Endometriosis-related Pain
Conditions
Brief summary
To evaluate the efficacy of three doses of quinagolide administered as an extended-release vaginal ring compared to placebo on reduction of moderate to severe endometriosis-related pain
Interventions
DRUGQuinagolide 720 µg
Vaginal ring containing quinagolide 720 µg for daily releases
DRUGQuinagolide 360 µg
Vaginal ring containing quinagolide 360 µg for daily releases
Vaginal ring containing quinagolide 1080 µg for daily releases
DRUGPlacebo
Matching placebo
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pre-menopausal females aged ≥18 years at time of signing informed consent(s) with regular menstrual cycles. * Body mass index (BMI) of 18-42 kg/m2 (both inclusive) at screening. * Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10 years before the run-in visit or visualization of persistent endometrioma by repeat ultrasound. * Transvaginal ultrasound documenting a uterus with no clinically significant abnormalities and presence of at least one ovary with no clinically significant abnormalities (with the exception of endometrioma) at the run-in visit. * Eligible participants experienced moderate to severe endometriosis-related pain, which was defined as at the run-in visit, the participant having an NRS score of ≥5 for the worst endometriosis related pain during the past menstrual cycle and at randomization, the participant having a mean daily NRS score of ≥4 for the worst endometriosis related pain during each run-in menstrual cycle.
Exclusion criteria
* History of no relief of endometriosis related pain after any medical therapy or surgery. However, history of partial pain relief, discontinuation due to side effects are not exclusionary. * Known bone diseases (e.g. osteoporosis, Paget's disease and osteomalacia) affecting bone resorption or bone formation markers. * Any significant abnormal findings of heart examinations before randomization. * History of mental illness including occurrence of acute psychosis, bipolar disorders and schizophrenia (except for well-controlled anxiety and/or depression with no changes to interventions for 6 months prior to start of run-in) * History of impulse control disorders including pathological gambling, compulsive buying, hypersexuality, and binge eating or being identified with potential impulse control disorder by the questionnaire for impulsive-compulsive disorders (a score ≥2 for any sub-questions of Question 3 or a score ≥1 for any sub-questions of Question 4) prior to randomization. * History of orthostatic hypotension or recurrent syncope.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes from baseline to cycle 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles |
| Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles |
| Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles |
| Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles. |
| Frequency of Avoiding Sexual Intercourse Due to Expected Pain | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | The participants recorded daily if they had sexual intercourse, in an e-diary. For the days when participants did not have intercourse, the participant recorded if the reason for not having intercourse was because they expected pain: Yes (I did not have intercourse this day, because I expected pain) or No (I did not have intercourse this day, but this was not because I expected pain). The numbers represent the cumulative number of days with no intercourse, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days. |
| Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles. |
| Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed weekly by participants in an e-Diary. EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. Changes over 4 menstrual cycles. |
| Changes in ECG Parameters Including QRS Duration at Cycle 4 | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by 12-lead ECG |
| Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded if this was menstrual bleeding: Yes (I had a vaginal bleeding that was menstrual bleeding) or No (I had a vaginal bleeding that was not menstrual bleeding). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days. |
| Changes in Vaginal Bleeding Pattern. | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded the assessed bleeding volume as either spotting (tiny amount of blood on underwear or panty liners), light bleeding (requiring 1-3 sanitary pads or tampons per day), moderate bleeding (requiring 4-6 sanitary pads or tampons per day), or heavy bleeding (requiring more than 6 sanitary pads or tampons per day). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days. |
| Percentage of Days With Mild and/or Strong Rescue Analgesics Used | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed daily by participants in an e-Diary |
| Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed daily by participants in an e-Diary |
| Responder Rate | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed as ≥30%, ≥50% and ≥70% reduction from the baseline in mean daily NRS score for the worst endometriosis-related pain, dysmenorrhea and non-menstrual pelvic pain and for the worst endometriosis-related pain impact |
| Changes in the Mean Individual and Total Symptom and Sign Severity Scores | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by the Biberoglu and Behrman (B&B) scale which is a 4-point scale with 0=none and 3=severe. The scores are the mean individual scores. The B&B scale consists of two parts. The first part of the B&B scale evaluates symptoms of endometriosis (i.e. pain). There are 3 subscales: pelvic pain(A, 0=none and 3=severe), dysmenorrhea (B, 0=none and 3=severe), and dyspareunia(C, 0=none and 3=severe). The total pelvic pain score is the sum of the three scores, i.e. A+B+C, which can range from 0 to 9. The second part of the B&B scale evaluates signs of endometriosis. There are 2 subscales pelvic tenderness (D, 0=none and 3=severe) and induration (E, 0=none and 3=severe) based on findings from a pelvic examination. The total physical pain score is the sum of the two scores, i.e. D+E, which can range from 0 to 6. The total symptom and sign severity score is the sum of all five scores, i.e. A+B+C+D+E, which can range from 0 to 15. The values are the change from baseline to cycle 4. |
| Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by the EHP-30 quality-of-life questionnaire completed by participants. Score ranges from 0-100 with lower score denoting improvement. |
| Changes in Patient Global Impression of Severity (PGIS) Scores | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by the PGIS scale completed by participants. PGIS is a 6-point scale depicting a participant's rating of their current conditions from good to bad. It ranges from 0 (none) to 5 (very severe). |
| Patient Global Impression of Change (PGIC) Scores | At cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by the PGIC scale completed by participants. PGIC is a 7-point scale depicting a patient's rating of their overall improvement from good to bad. |
| Plasma Concentration of Quinagolide and Metabolites | Within 5 days after first ring insertion and at around 1 month, 3 months, 3.5 months and 4 months after baseline (each cycle is approximately 28 days) | Assessed by blood samples collection |
| Serum Levels of Mid-luteal Phase Progesterone | At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days) | Assessed by blood samples collection |
| Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days) | Assessed by blood samples collection |
| Serum Levels of Estradiol | At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days) | Assessed by blood samples collection |
| Serum Levels of Prolactin | At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days) | Assessed by blood samples collection |
| Serum Levels of Thyrotropin (TSH) | At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days) | Assessed by blood samples collection |
| Serum Levels of Insulin-like Growth Factor-1 (IGF-1) | At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days) | Assessed by blood samples collection |
| Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx) | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by blood samples collection. Changes from baseline to cycle 4 |
| Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP) | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by blood samples collection. Changes from baseline to cycle 4 |
| Changes in ECG Parameters Including PR Interval at Cycle 4 | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by 12-lead ECG |
| Changes in ECG Parameters Including QT Interval at Cycle 4 | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by 12-lead ECG |
| Changes in ECG Parameters Including QTcF Interval at Cycle 4 | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by 12-lead ECG |
| Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by echocardiography. Each echocardiography was to be assessed as normal or abnormal according to American College of Cardiology/American Heart Association guidelines for valvular heart disease. If abnormal, the level of valvular regurgitation and valvular stenosis was specified as mild, moderate or severe and valvular structure was evaluated as well. Measured at cycle 4. |
| Proportion of Subjects Identified With Potential Impulse Control Disorders | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by the questionnaire for impulsive-compulsive disorders completed by participants. Measured at cycle 4. |
| Frequency and Intensity of Adverse Events | From signing informed consent through study completion, around 8 months | Assessed by an Adverse Events Log completed by the Investigator |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Protein | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Urate | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Basophils | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in Circulating Levels of Clinical Haematology Parameters: Platelets | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Days with menstrual bleeding (dysmenorrhea). No menstrual bleeding (non-menstrual pelvic pain) Changes from baseline to cycle 4 |
| Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity) | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by urine sample collection (dip-stick test). Overall Urinalysis Result. |
| Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
| Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by urine samples collection |
| Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by a questionnaire completed by participants, addressing ring insertion |
| Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by a questionnaire completed by participants, addressing ring removal. |
| Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Assessed by a questionnaire completed by participants, addressing any feeling of the ring while the ring is in the body. |
| Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes | At baseline and at menstrual cycle 4 (around 4 months) | Assessed by blood samples collection |
Countries
United States
Participant flow
Recruitment details
The trial was performed in 12 investigational sites in the US between Dec 2018 and Feb 2022
Pre-assignment details
In total, 107 participants were screened. Of these, 85 were screening failures and 22 were randomized. All the randomized participants were exposed to the investigational medical product (IMP): 6 participants to Quinagolide 360 µg, 5 participants to Quinagolide 720 µg, 8 participants to Quinagolide 1080 µg and 3 participants to Placebo.
Participants by arm
| Arm | Count |
|---|---|
| Quinagolide 360 µg Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases | 6 |
| Quinagolide 720 µg Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases | 5 |
| Quinagolide 1080 µg Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases | 8 |
| Placebo Vaginal ring containing matching placebo
Placebo: Matching placebo | 3 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | Other | 0 | 0 | 1 | 0 |
| Overall Study | Pregnancy | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Quinagolide 720 µg | Quinagolide 360 µg | Quinagolide 1080 µg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 6 Participants | 8 Participants | 3 Participants | 22 Participants |
| Age, Continuous | 33.2 years STANDARD_DEVIATION 9.36 | 29.5 years STANDARD_DEVIATION 8.22 | 37.5 years STANDARD_DEVIATION 6.65 | 32.0 years STANDARD_DEVIATION 5.2 | 33.6 years STANDARD_DEVIATION 7.82 |
| Body Mass Index (BMI) | 26.58 kg/m^2 STANDARD_DEVIATION 5.006 | 28.33 kg/m^2 STANDARD_DEVIATION 5.428 | 29.91 kg/m^2 STANDARD_DEVIATION 5.038 | 32.33 kg/m^2 STANDARD_DEVIATION 7.19 | 29.05 kg/m^2 STANDARD_DEVIATION 5.348 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 5 Participants | 6 Participants | 3 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Numerical Rating Scale (NRS) at baseline 10 | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Numerical Rating Scale (NRS) at baseline 6 | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Numerical Rating Scale (NRS) at baseline 7 | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
| Numerical Rating Scale (NRS) at baseline 8 | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 4 Participants |
| Numerical Rating Scale (NRS) at baseline 9 | 2 Participants | 2 Participants | 4 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 6 Participants | 2 Participants | 18 Participants |
| Region of Enrollment United States | 5 participants | 6 participants | 8 participants | 3 participants | 22 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 8 Participants | 3 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 | 0 / 8 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 7 |
| other Total, other adverse events | 4 / 6 | 3 / 5 | 2 / 8 | 2 / 3 | 1 / 3 | 2 / 3 | 5 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 | 0 / 8 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 7 |
Outcome results
Primary
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes from baseline to cycle 4.
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | -0.66 score on a scale | Standard Deviation 1.213 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | -2.04 score on a scale | Standard Deviation 2.092 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | -2.14 score on a scale | Standard Deviation 1.344 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | -3.68 score on a scale | Standard Deviation 1.685 |
Secondary
Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP)
Assessed by blood samples collection. Changes from baseline to cycle 4
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP) | -1.4 ng/mL | Standard Deviation 9.56 |
| Quinagolide 720 µg | Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP) | -3.5 ng/mL | Standard Deviation 6.36 |
| Quinagolide 1080 µg | Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP) | 10.3 ng/mL | Standard Deviation 20.12 |
| Placebo | Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP) | -21.0 ng/mL | — |
Secondary
Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx)
Assessed by blood samples collection. Changes from baseline to cycle 4
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx) | -0.060 ng/mL | Standard Deviation 0.121 |
| Quinagolide 720 µg | Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx) | 0.277 ng/mL | Standard Deviation 0.3026 |
| Quinagolide 1080 µg | Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx) | 0.067 ng/mL | Standard Deviation 0.0685 |
| Placebo | Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx) | -0.031 ng/mL | Standard Deviation 0.0354 |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase | -8.3 IU/L | Standard Deviation 23.26 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase | 46.0 IU/L | Standard Deviation 69.3 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase | -5.8 IU/L | Standard Deviation 6.38 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase | -3.0 IU/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin | -0.5 g/L | Standard Deviation 3 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin | 0.5 g/L | Standard Deviation 2.12 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin | -2.8 g/L | Standard Deviation 2.28 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin | -3.0 g/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase | -16.5 IU/L | Standard Deviation 20.94 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase | 26.5 IU/L | Standard Deviation 45.96 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase | -7.2 IU/L | Standard Deviation 14.62 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase | -13.0 IU/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase | -5.3 IU/L | Standard Deviation 14.57 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase | 26.5 IU/L | Standard Deviation 41.72 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase | -0.6 IU/L | Standard Deviation 1.14 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase | 4.0 IU/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate | -0.8 mmol/L | Standard Deviation 2.63 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate | 0.5 mmol/L | Standard Deviation 3.54 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate | -0.2 mmol/L | Standard Deviation 1.92 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate | -2.0 mmol/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin | 1.3 umol/L | Standard Deviation 2.57 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin | 4.3 umol/L | Standard Deviation 3.63 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin | -2.1 umol/L | Standard Deviation 2.23 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin | 1.7 umol/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium | 0.0 mmol/L | Standard Deviation 0.06 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium | 0.0 mmol/L | Standard Deviation 0.05 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium | -0.1 mmol/L | Standard Deviation 0.07 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium | -0.1 mmol/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride | 0.8 mmol/L | Standard Deviation 1.71 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride | 1.0 mmol/L | Standard Deviation 0 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride | 1.4 mmol/L | Standard Deviation 2.51 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride | 2.5 mmol/L | Standard Deviation 2.12 |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol | 0.7 mmol/L | Standard Deviation 0.46 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol | 0.5 mmol/L | Standard Deviation 0.49 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol | 0.1 mmol/L | Standard Deviation 0.27 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol | -0.1 mmol/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine | -3.3 umol/L | Standard Deviation 13.39 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine | -10.6 umol/L | Standard Deviation 3.75 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine | 0.0 umol/L | Standard Deviation 7.26 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine | 0.9 umol/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin | 0.0 umol/L | Standard Deviation 0 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin | 0.0 umol/L | Standard Deviation 0 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin | -0.7 umol/L | Standard Deviation 0.72 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin | 0.0 umol/L | Standard Deviation 0 |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase | -3.5 IU/L | Standard Deviation 9.75 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase | 11.0 IU/L | Standard Deviation 14.14 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase | -2.8 IU/L | Standard Deviation 11.32 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase | -9.0 IU/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose | -0.3 mmol/L | Standard Deviation 0.4 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose | -0.6 mmol/L | Standard Deviation 0.59 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose | -0.1 mmol/L | Standard Deviation 0.49 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose | 4.8 mmol/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase | -11.8 IU/L | Standard Deviation 14.86 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase | 35.0 IU/L | Standard Deviation 55.15 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase | -16.0 IU/L | Standard Deviation 14.68 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase | 8.0 IU/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate | 0.1 mmol/L | Standard Deviation 0.08 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate | -0.1 mmol/L | Standard Deviation 0.43 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate | 0.0 mmol/L | Standard Deviation 0.12 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate | 0.0 mmol/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium | -0.2 mmol/L | Standard Deviation 0.58 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium | -0.1 mmol/L | Standard Deviation 0 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium | -0.3 mmol/L | Standard Deviation 0.32 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium | -0.5 mmol/L | Standard Deviation 0 |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Protein
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Protein | -0.8 g/L | Standard Deviation 4.35 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Protein | 0.0 g/L | Standard Deviation 2.83 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Protein | -3.4 g/L | Standard Deviation 3.65 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Protein | -5.0 g/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium | 1.5 mmol/L | Standard Deviation 1.73 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium | -1.5 mmol/L | Standard Deviation 3.54 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium | 1.2 mmol/L | Standard Deviation 2.39 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium | 0.5 mmol/L | Standard Deviation 4.95 |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Urate
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Urate | -5.9 umol/L | Standard Deviation 31.85 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Urate | -23.8 umol/L | Standard Deviation 50.47 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Urate | 10.7 umol/L | Standard Deviation 64.8 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Urate | 41.6 umol/L | — |
Secondary
Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen | 0.3 mmol/L | Standard Deviation 2.21 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen | -2.0 mmol/L | Standard Deviation 0.76 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen | -0.4 mmol/L | Standard Deviation 0.84 |
| Placebo | Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen | -0.7 mmol/L | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Basophils
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Basophils | 0.0 *10^3 cells/uL | Standard Deviation 0.03 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Basophils | 0.0 *10^3 cells/uL | Standard Deviation 0.02 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Basophils | 0.0 *10^3 cells/uL | Standard Deviation 0.02 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Basophils | 0.0 *10^3 cells/uL | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute | -0.3 Basophils Absolute (%) | Standard Deviation 0.25 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute | -0.4 Basophils Absolute (%) | Standard Deviation 0.21 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute | 0.0 Basophils Absolute (%) | Standard Deviation 0.05 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute | 0.1 Basophils Absolute (%) | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils | -0.1 *10^3 cells/uL | Standard Deviation 0.02 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils | -0.1 *10^3 cells/uL | Standard Deviation 0.14 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils | 0.0 *10^3 cells/uL | Standard Deviation 0.13 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils | 0.0 *10^3 cells/uL | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute | -0.6 Eosinophils Absolute (%) | Standard Deviation 0.71 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute | -0.3 Eosinophils Absolute (%) | Standard Deviation 2.19 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute | -1.4 Eosinophils Absolute (%) | Standard Deviation 3.73 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute | 0.0 Eosinophils Absolute (%) | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin | 0.3 pg/cell | Standard Deviation 0.58 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin | 0.0 pg/cell | Standard Deviation 0 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin | -0.2 pg/cell | Standard Deviation 0.45 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin | 0.0 pg/cell | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration | 0.2 mmol/L | Standard Deviation 0.72 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration | 0.3 mmol/L | Standard Deviation 1.32 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration | -0.1 mmol/L | Standard Deviation 0.52 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration | 1.2 mmol/L | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume | 0.0 fL | Standard Deviation 2.65 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume | 0.5 fL | Standard Deviation 3.54 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume | 0.2 fL | Standard Deviation 1.64 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume | -3.0 fL | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes | -0.1 10^12 cells/L | Standard Deviation 0.35 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes | -0.1 10^12 cells/L | Standard Deviation 0.42 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes | -0.2 10^12 cells/L | Standard Deviation 0.24 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes | -0.1 10^12 cells/L | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit | 0.0 RATIO | Standard Deviation 0.03 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit | 0.0 RATIO | Standard Deviation 0.02 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit | 0.0 RATIO | Standard Deviation 0.03 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit | 0.0 RATIO | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin | 1.3 g/L | Standard Deviation 10.07 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin | -1.5 g/L | Standard Deviation 14.85 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin | -6.0 g/L | Standard Deviation 7.87 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin | 0.0 g/L | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes | 0.3 10^9 cells/L | Standard Deviation 1.72 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes | -0.5 10^9 cells/L | Standard Deviation 2.05 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes | 0.0 10^9 cells/L | Standard Deviation 1.63 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes | 0.0 10^9 cells/L | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes | 0.3 *10^3 cells/uL | Standard Deviation 0.39 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes | -0.2 *10^3 cells/uL | Standard Deviation 0.54 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes | -0.1 *10^3 cells/uL | Standard Deviation 0.43 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes | 0.3 *10^3 cells/uL | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute | 2.5 Lymphocytes Absolute (%) | Standard Deviation 1.96 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute | -0.6 Lymphocytes Absolute (%) | Standard Deviation 0.35 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute | -2.1 Lymphocytes Absolute (%) | Standard Deviation 8.22 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute | 3.9 Lymphocytes Absolute (%) | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes | -0.2 *10^3 cells/uL | Standard Deviation 0.03 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes | -0.2 *10^3 cells/uL | Standard Deviation 0.04 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes | 0.0 *10^3 cells/uL | Standard Deviation 0.13 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes | 0.0 *10^3 cells/uL | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute | -2.1 Monocytes Absolute (%) | Standard Deviation 0.26 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute | -2.2 Monocytes Absolute (%) | Standard Deviation 1.34 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute | -0.1 Monocytes Absolute (%) | Standard Deviation 1.32 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute | 0.6 Monocytes Absolute (%) | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils | 0.3 *10^3 cells/uL | Standard Deviation 1.37 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils | 0.0 *10^3 cells/uL | Standard Deviation 1.67 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils | 0.1 *10^3 cells/uL | Standard Deviation 1.52 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils | -0.3 *10^3 cells/uL | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute | 0.6 Neutrophils Absolute (%) | Standard Deviation 2.74 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute | 3.4 Neutrophils Absolute (%) | Standard Deviation 2.9 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute | 3.7 Neutrophils Absolute (%) | Standard Deviation 7.28 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute | -4.6 Neutrophils Absolute (%) | — |
Secondary
Changes in Circulating Levels of Clinical Haematology Parameters: Platelets
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Platelets | -10.3 10^9 cells/L | Standard Deviation 26.54 |
| Quinagolide 720 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Platelets | 36.5 10^9 cells/L | Standard Deviation 50.2 |
| Quinagolide 1080 µg | Changes in Circulating Levels of Clinical Haematology Parameters: Platelets | 1.8 10^9 cells/L | Standard Deviation 33.33 |
| Placebo | Changes in Circulating Levels of Clinical Haematology Parameters: Platelets | 12.0 10^9 cells/L | — |
Secondary
Changes in ECG Parameters Including PR Interval at Cycle 4
Assessed by 12-lead ECG
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in ECG Parameters Including PR Interval at Cycle 4 | -1.8 msec | Standard Deviation 11.17 |
| Quinagolide 720 µg | Changes in ECG Parameters Including PR Interval at Cycle 4 | 8.0 msec | Standard Deviation 8.72 |
| Quinagolide 1080 µg | Changes in ECG Parameters Including PR Interval at Cycle 4 | 1.0 msec | Standard Deviation 11.66 |
| Placebo | Changes in ECG Parameters Including PR Interval at Cycle 4 | -2.5 msec | Standard Deviation 2.12 |
Secondary
Changes in ECG Parameters Including QRS Duration at Cycle 4
Assessed by 12-lead ECG
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in ECG Parameters Including QRS Duration at Cycle 4 | -0.2 msec | Standard Deviation 4.82 |
| Quinagolide 720 µg | Changes in ECG Parameters Including QRS Duration at Cycle 4 | 5.0 msec | Standard Deviation 5.83 |
| Quinagolide 1080 µg | Changes in ECG Parameters Including QRS Duration at Cycle 4 | 2.8 msec | Standard Deviation 7.19 |
| Placebo | Changes in ECG Parameters Including QRS Duration at Cycle 4 | -7.5 msec | Standard Deviation 9.19 |
Secondary
Changes in ECG Parameters Including QTcF Interval at Cycle 4
Assessed by 12-lead ECG
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in ECG Parameters Including QTcF Interval at Cycle 4 | -6.2 msec | Standard Deviation 6.18 |
| Quinagolide 720 µg | Changes in ECG Parameters Including QTcF Interval at Cycle 4 | 1.5 msec | Standard Deviation 11.39 |
| Quinagolide 1080 µg | Changes in ECG Parameters Including QTcF Interval at Cycle 4 | 3.2 msec | Standard Deviation 13.22 |
| Placebo | Changes in ECG Parameters Including QTcF Interval at Cycle 4 | -17.5 msec | Standard Deviation 33.23 |
Secondary
Changes in ECG Parameters Including QT Interval at Cycle 4
Assessed by 12-lead ECG
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 360 µg | Changes in ECG Parameters Including QT Interval at Cycle 4 | -1.2 msec | Standard Deviation 22.33 |
| Quinagolide 720 µg | Changes in ECG Parameters Including QT Interval at Cycle 4 | -7.5 msec | Standard Deviation 23.61 |
| Quinagolide 1080 µg | Changes in ECG Parameters Including QT Interval at Cycle 4 | 18.0 msec | Standard Deviation 30.32 |
| Placebo | Changes in ECG Parameters Including QT Interval at Cycle 4 | 7.0 msec | Standard Deviation 5.66 |
Secondary
Changes in Patient Global Impression of Severity (PGIS) Scores
Assessed by the PGIS scale completed by participants. PGIS is a 6-point scale depicting a participant's rating of their current conditions from good to bad. It ranges from 0 (none) to 5 (very severe).
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle | No Change | 1 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle | Decreased score | 2 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of endometriosis-related pain on daily activities during the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle | Decreased score | 3 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of endometriosis-related pain on daily activities during the last menstrual cycle | Decreased score | 2 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the last menstrual cycle | Decreased score | 2 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle | No Change | 1 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle | No Change | 1 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle | Decreased score | 3 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle | No Change | 2 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of endometriosis-related pain on daily activities during the last menstrual cycle | No Change | 2 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle | Decreased score | 2 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the last menstrual cycle | No Change | 2 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 360 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle | Increased score | 1 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle | No Change | 0 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle | Decreased score | 3 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle | Decreased score | 4 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of endometriosis-related pain on daily activities during the last menstrual cycle | No Change | 0 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of endometriosis-related pain on daily activities during the last menstrual cycle | Decreased score | 4 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of endometriosis-related pain on daily activities during the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the last menstrual cycle | No Change | 1 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle | No Change | 0 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle | Decreased score | 4 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle | No Change | 1 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle | No Change | 0 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the last menstrual cycle | Decreased score | 3 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 720 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle | Decreased score | 4 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle | No Change | 1 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle | No Change | 1 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the last menstrual cycle | No Change | 3 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the last menstrual cycle | Decreased score | 3 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle | No Change | 1 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle | Decreased score | 4 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle | Increased score | 1 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle | No Change | 2 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle | Decreased score | 4 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of endometriosis-related pain on daily activities during the last menstrual cycle | No Change | 0 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of endometriosis-related pain on daily activities during the last menstrual cycle | Decreased score | 5 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of endometriosis-related pain on daily activities during the last menstrual cycle | Increased score | 1 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle | Decreased score | 5 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle | Decreased score | 4 Participants |
| Quinagolide 1080 µg | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle | Increased score | 1 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the last menstrual cycle | No Change | 0 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle | Decreased score | 2 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle | Decreased score | 2 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle | No Change | 0 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle | No Change | 0 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle | Decreased score | 2 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle | No Change | 0 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle | No Change | 0 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the last menstrual cycle | Increased score | 0 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during the last menstrual cycle | Decreased score | 2 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle | Decreased score | 2 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of endometriosis-related pain on daily activities during the last menstrual cycle | Increased score | 0 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of endometriosis-related pain on daily activities during the last menstrual cycle | Decreased score | 2 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Impact of endometriosis-related pain on daily activities during the last menstrual cycle | No Change | 0 Participants |
| Placebo | Changes in Patient Global Impression of Severity (PGIS) Scores | Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle | Increased score | 0 Participants |
Secondary
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores
Assessed by the EHP-30 quality-of-life questionnaire completed by participants. Score ranges from 0-100 with lower score denoting improvement.
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 1 | -7.2 score on a scale | Standard Deviation 15.22 |
| Quinagolide 360 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 2 | -2.0 score on a scale | Standard Deviation 22.55 |
| Quinagolide 360 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 3 | -2.8 score on a scale | Standard Deviation 20.98 |
| Quinagolide 360 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 4 | -4.0 score on a scale | Standard Deviation 33.79 |
| Quinagolide 720 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 2 | -12.0 score on a scale | Standard Deviation 25.88 |
| Quinagolide 720 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 3 | -12.4 score on a scale | Standard Deviation 26.02 |
| Quinagolide 720 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 4 | -23.3 score on a scale | Standard Deviation 25.63 |
| Quinagolide 720 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 1 | -12.8 score on a scale | Standard Deviation 18.09 |
| Quinagolide 1080 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 3 | -18.7 score on a scale | Standard Deviation 15.25 |
| Quinagolide 1080 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 2 | -19.7 score on a scale | Standard Deviation 15.52 |
| Quinagolide 1080 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 4 | -23.3 score on a scale | Standard Deviation 12.86 |
| Quinagolide 1080 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 1 | -8.8 score on a scale | Standard Deviation 13.86 |
| Placebo | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 4 | -50.5 score on a scale | Standard Deviation 31.82 |
| Placebo | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 2 | -49.5 score on a scale | Standard Deviation 68.59 |
| Placebo | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 1 | -39.5 score on a scale | Standard Deviation 74.25 |
| Placebo | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores | Cycle 3 | -14.0 score on a scale | Standard Deviation 11.31 |
Secondary
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 1 | -1.10 score on a scale | Standard Deviation 1.051 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 2 | -0.95 score on a scale | Standard Deviation 1.678 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 3 | 0.04 score on a scale | Standard Deviation 1.076 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 4 | -0.51 score on a scale | Standard Deviation 0.989 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 3 | -1.00 score on a scale | Standard Deviation 1.442 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 1 | -1.48 score on a scale | Standard Deviation 1.69 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 4 | -3.70 score on a scale | Standard Deviation 3.252 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 2 | -1.76 score on a scale | Standard Deviation 3.427 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 1 | -0.61 score on a scale | Standard Deviation 0.699 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 2 | -1.17 score on a scale | Standard Deviation 1.545 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 3 | -1.69 score on a scale | Standard Deviation 1.429 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 4 | -2.54 score on a scale | Standard Deviation 1.787 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 3 | -3.90 score on a scale | Standard Deviation 0.495 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 2 | -1.15 score on a scale | Standard Deviation 1.556 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 4 | -4.90 score on a scale | Standard Deviation 0.495 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea. | Cycle 1 | -4.40 score on a scale | Standard Deviation 4.455 |
Secondary
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles.
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 1 | -1.62 score on a scale | Standard Deviation 1.85 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 2 | -1.43 score on a scale | Standard Deviation 2.008 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 3 | -0.53 score on a scale | Standard Deviation 1.514 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 4 | -1.45 score on a scale | Standard Deviation 1.468 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 3 | -0.29 score on a scale | Standard Deviation 1.551 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 4 | 0.85 score on a scale | Standard Deviation 1.109 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 1 | -0.49 score on a scale | Standard Deviation 1.088 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 2 | -0.06 score on a scale | Standard Deviation 0.756 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 3 | -2.12 score on a scale | Standard Deviation 2.791 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 2 | -1.50 score on a scale | Standard Deviation 1.542 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 4 | -2.03 score on a scale | Standard Deviation 0.864 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 1 | -1.69 score on a scale | Standard Deviation 1.972 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 3 | -7.00 score on a scale | — |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 1 | -1.00 score on a scale | — |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse. | Cycle 4 | -5.00 score on a scale | — |
Secondary
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 3 | -0.61 score on a scale | Standard Deviation 1.057 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 2 | -0.79 score on a scale | Standard Deviation 1.343 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 1 | -0.33 score on a scale | Standard Deviation 1.2 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 4 | -0.66 score on a scale | Standard Deviation 1.213 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 1 | -1.42 score on a scale | Standard Deviation 0.99 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 3 | -1.71 score on a scale | Standard Deviation 1.788 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 2 | -2.39 score on a scale | Standard Deviation 3.127 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 4 | -2.04 score on a scale | Standard Deviation 2.092 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 1 | -0.51 score on a scale | Standard Deviation 0.733 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 2 | -1.63 score on a scale | Standard Deviation 1.254 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 3 | -1.51 score on a scale | Standard Deviation 1.912 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 4 | -2.14 score on a scale | Standard Deviation 1.344 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 2 | -1.16 score on a scale | Standard Deviation 1.19 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 1 | -1.97 score on a scale | Standard Deviation 1.397 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 4 | -3.68 score on a scale | Standard Deviation 1.685 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain. | Cycle 3 | -2.29 score on a scale | Standard Deviation 2.152 |
Secondary
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Days with menstrual bleeding (dysmenorrhea). No menstrual bleeding (non-menstrual pelvic pain) Changes from baseline to cycle 4
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding | Dysmenorrhea | -0.51 score on a scale | Standard Deviation 0.989 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding | Non-menstrual pelvic pain | -0.69 score on a scale | Standard Deviation 1.236 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding | Dysmenorrhea | -3.70 score on a scale | Standard Deviation 3.252 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding | Non-menstrual pelvic pain | -2.04 score on a scale | Standard Deviation 2.39 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding | Non-menstrual pelvic pain | -2.08 score on a scale | Standard Deviation 1.274 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding | Dysmenorrhea | -2.54 score on a scale | Standard Deviation 1.787 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding | Dysmenorrhea | -4.90 score on a scale | Standard Deviation 0.495 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding | Non-menstrual pelvic pain | -3.37 score on a scale | Standard Deviation 2.04 |
Secondary
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles.
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 1 | -0.27 score on a scale | Standard Deviation 1.095 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 2 | -0.53 score on a scale | Standard Deviation 0.867 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 3 | -0.08 score on a scale | Standard Deviation 1.438 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 4 | -0.32 score on a scale | Standard Deviation 1.647 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 2 | -2.19 score on a scale | Standard Deviation 3.194 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 3 | -1.44 score on a scale | Standard Deviation 1.871 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 4 | -1.57 score on a scale | Standard Deviation 2.203 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 1 | -1.45 score on a scale | Standard Deviation 1.079 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 3 | -0.87 score on a scale | Standard Deviation 1.847 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 2 | -0.95 score on a scale | Standard Deviation 1.281 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 4 | -1.48 score on a scale | Standard Deviation 1.649 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 1 | -0.31 score on a scale | Standard Deviation 0.741 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 4 | -3.61 score on a scale | Standard Deviation 1.678 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 2 | -0.76 score on a scale | Standard Deviation 1.518 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 1 | -1.77 score on a scale | Standard Deviation 1.324 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function. | Cycle 3 | -2.02 score on a scale | Standard Deviation 2.631 |
Secondary
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 4 | -0.69 score on a scale | Standard Deviation 1.236 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 1 | -0.09 score on a scale | Standard Deviation 1.457 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 3 | -0.77 score on a scale | Standard Deviation 1.194 |
| Quinagolide 360 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 2 | -0.69 score on a scale | Standard Deviation 1.484 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 1 | -1.45 score on a scale | Standard Deviation 0.926 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 2 | -2.71 score on a scale | Standard Deviation 2.995 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 4 | -2.04 score on a scale | Standard Deviation 2.39 |
| Quinagolide 720 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 3 | -3.21 score on a scale | Standard Deviation 3.39 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 2 | -1.64 score on a scale | Standard Deviation 1.354 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 1 | -0.61 score on a scale | Standard Deviation 0.847 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 4 | -2.08 score on a scale | Standard Deviation 1.274 |
| Quinagolide 1080 µg | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 3 | -1.39 score on a scale | Standard Deviation 2.306 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 4 | -3.37 score on a scale | Standard Deviation 2.04 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 3 | -1.88 score on a scale | Standard Deviation 2.632 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 1 | -1.42 score on a scale | Standard Deviation 0.693 |
| Placebo | Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain. | Cycle 2 | -1.22 score on a scale | Standard Deviation 1.036 |
Secondary
Changes in the Mean Individual and Total Symptom and Sign Severity Scores
Assessed by the Biberoglu and Behrman (B&B) scale which is a 4-point scale with 0=none and 3=severe. The scores are the mean individual scores. The B&B scale consists of two parts. The first part of the B&B scale evaluates symptoms of endometriosis (i.e. pain). There are 3 subscales: pelvic pain(A, 0=none and 3=severe), dysmenorrhea (B, 0=none and 3=severe), and dyspareunia(C, 0=none and 3=severe). The total pelvic pain score is the sum of the three scores, i.e. A+B+C, which can range from 0 to 9. The second part of the B&B scale evaluates signs of endometriosis. There are 2 subscales pelvic tenderness (D, 0=none and 3=severe) and induration (E, 0=none and 3=severe) based on findings from a pelvic examination. The total physical pain score is the sum of the two scores, i.e. D+E, which can range from 0 to 6. The total symptom and sign severity score is the sum of all five scores, i.e. A+B+C+D+E, which can range from 0 to 15. The values are the change from baseline to cycle 4.
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Total symptom and sign severity score | -2.7 score on a scale | Standard Deviation 3.21 |
| Quinagolide 360 µg | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Total physical sign pain score | -1.7 score on a scale | Standard Deviation 1.53 |
| Quinagolide 360 µg | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Total pelvic pain score | -1.0 score on a scale | Standard Deviation 1.73 |
| Quinagolide 720 µg | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Total symptom and sign severity score | -4.5 score on a scale | Standard Deviation 4.95 |
| Quinagolide 720 µg | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Total pelvic pain score | -3.0 score on a scale | Standard Deviation 5.66 |
| Quinagolide 720 µg | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Total physical sign pain score | -1.5 score on a scale | Standard Deviation 0.71 |
| Quinagolide 1080 µg | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Total physical sign pain score | -2.2 score on a scale | Standard Deviation 1.48 |
| Quinagolide 1080 µg | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Total pelvic pain score | -2.4 score on a scale | Standard Deviation 2.51 |
| Quinagolide 1080 µg | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Total symptom and sign severity score | -4.6 score on a scale | Standard Deviation 3.91 |
| Placebo | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Total symptom and sign severity score | -6.0 score on a scale | — |
| Placebo | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Total physical sign pain score | -1.0 score on a scale | — |
| Placebo | Changes in the Mean Individual and Total Symptom and Sign Severity Scores | Total pelvic pain score | -5.0 score on a scale | — |
Secondary
Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain.
Assessed weekly by participants in an e-Diary. EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. Changes over 4 menstrual cycles.
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 3 | -3.19 score on a scale | Standard Deviation 14.065 |
| Quinagolide 360 µg | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 4 | -6.75 score on a scale | Standard Deviation 15.743 |
| Quinagolide 360 µg | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 1 | -5.54 score on a scale | Standard Deviation 10.939 |
| Quinagolide 360 µg | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 2 | -5.69 score on a scale | Standard Deviation 16.059 |
| Quinagolide 720 µg | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 1 | -5.54 score on a scale | Standard Deviation 11.787 |
| Quinagolide 720 µg | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 3 | -21.19 score on a scale | Standard Deviation 31.336 |
| Quinagolide 720 µg | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 4 | -24.75 score on a scale | Standard Deviation 35.171 |
| Quinagolide 720 µg | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 2 | -13.53 score on a scale | Standard Deviation 28.807 |
| Quinagolide 1080 µg | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 4 | -16.01 score on a scale | Standard Deviation 8.624 |
| Quinagolide 1080 µg | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 2 | -14.27 score on a scale | Standard Deviation 8.47 |
| Quinagolide 1080 µg | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 1 | -7.03 score on a scale | Standard Deviation 10.05 |
| Quinagolide 1080 µg | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 3 | -13.70 score on a scale | Standard Deviation 12.564 |
| Placebo | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 3 | -27.89 score on a scale | Standard Deviation 27.253 |
| Placebo | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 4 | -31.68 score on a scale | Standard Deviation 21.896 |
| Placebo | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 2 | -4.12 score on a scale | Standard Deviation 17.477 |
| Placebo | Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain. | Cycle 1 | -26.66 score on a scale | Standard Deviation 18.146 |
Secondary
Changes in Vaginal Bleeding Pattern.
The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded the assessed bleeding volume as either spotting (tiny amount of blood on underwear or panty liners), light bleeding (requiring 1-3 sanitary pads or tampons per day), moderate bleeding (requiring 4-6 sanitary pads or tampons per day), or heavy bleeding (requiring more than 6 sanitary pads or tampons per day). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern. | Moderate - Cycle 4 | 9 Number of days |
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern. | Light - Cycle 4 | 8 Number of days |
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern. | Moderate - Baseline | 10 Number of days |
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern. | No Bleeding - Cycle 4 | 91 Number of days |
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern. | Heavy - Cycle 4 | 3 Number of days |
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern. | Heavy - Baseline | 5 Number of days |
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern. | No bleeding - Baseline | 91 Number of days |
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern. | Spotting - Cycle 4 | 12 Number of days |
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern. | Light - Baseline | 17 Number of days |
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern. | Spotting - Baseline | 18 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern. | Spotting - Baseline | 9 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern. | Light - Cycle 4 | 7 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern. | Moderate - Cycle 4 | 4 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern. | Moderate - Baseline | 11 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern. | Heavy - Baseline | 9 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern. | Light - Baseline | 11 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern. | No bleeding - Baseline | 101 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern. | No Bleeding - Cycle 4 | 57 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern. | Spotting - Cycle 4 | 8 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern. | Heavy - Cycle 4 | 2 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern. | Spotting - Baseline | 16 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern. | Light - Baseline | 12 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern. | Moderate - Baseline | 15 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern. | Heavy - Baseline | 10 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern. | No Bleeding - Cycle 4 | 110 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern. | Spotting - Cycle 4 | 11 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern. | Light - Cycle 4 | 9 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern. | Moderate - Cycle 4 | 10 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern. | Heavy - Cycle 4 | 5 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern. | No bleeding - Baseline | 144 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern. | Spotting - Cycle 4 | 2 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern. | Light - Baseline | 8 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern. | Heavy - Cycle 4 | 3 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern. | No Bleeding - Cycle 4 | 50 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern. | Heavy - Baseline | 3 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern. | Spotting - Baseline | 3 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern. | No bleeding - Baseline | 56 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern. | Moderate - Baseline | 3 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern. | Moderate - Cycle 4 | 3 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern. | Light - Cycle 4 | 9 Number of days |
Secondary
Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period
The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded if this was menstrual bleeding: Yes (I had a vaginal bleeding that was menstrual bleeding) or No (I had a vaginal bleeding that was not menstrual bleeding). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Baseline Yes | 38 Number of days |
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Baseline No | 11 Number of days |
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Cycle 4 Yes | 29 Number of days |
| Quinagolide 360 µg | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Cycle 4 No | 3 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Cycle 4 No | 5 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Cycle 4 Yes | 16 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Baseline Yes | 37 Number of days |
| Quinagolide 720 µg | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Baseline No | 0 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Baseline No | 10 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Baseline Yes | 42 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Cycle 4 Yes | 33 Number of days |
| Quinagolide 1080 µg | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Cycle 4 No | 2 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Baseline Yes | 15 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Baseline No | 2 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Cycle 4 Yes | 17 Number of days |
| Placebo | Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period | Bleeding related to period - Cycle 4 No | 0 Number of days |
Secondary
Frequency and Intensity of Adverse Events
Assessed by an Adverse Events Log completed by the Investigator
Time frame: From signing informed consent through study completion, around 8 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinagolide 360 µg | Frequency and Intensity of Adverse Events | Treatment emergent adverse events | 4 participants |
| Quinagolide 360 µg | Frequency and Intensity of Adverse Events | Mild adverse events | 4 participants |
| Quinagolide 360 µg | Frequency and Intensity of Adverse Events | Moderate adverse events | 2 participants |
| Quinagolide 360 µg | Frequency and Intensity of Adverse Events | Severe adverse events | 0 participants |
| Quinagolide 720 µg | Frequency and Intensity of Adverse Events | Mild adverse events | 2 participants |
| Quinagolide 720 µg | Frequency and Intensity of Adverse Events | Moderate adverse events | 2 participants |
| Quinagolide 720 µg | Frequency and Intensity of Adverse Events | Severe adverse events | 1 participants |
| Quinagolide 720 µg | Frequency and Intensity of Adverse Events | Treatment emergent adverse events | 3 participants |
| Quinagolide 1080 µg | Frequency and Intensity of Adverse Events | Moderate adverse events | 2 participants |
| Quinagolide 1080 µg | Frequency and Intensity of Adverse Events | Mild adverse events | 4 participants |
| Quinagolide 1080 µg | Frequency and Intensity of Adverse Events | Severe adverse events | 0 participants |
| Quinagolide 1080 µg | Frequency and Intensity of Adverse Events | Treatment emergent adverse events | 5 participants |
| Placebo | Frequency and Intensity of Adverse Events | Severe adverse events | 0 participants |
| Placebo | Frequency and Intensity of Adverse Events | Mild adverse events | 2 participants |
| Placebo | Frequency and Intensity of Adverse Events | Treatment emergent adverse events | 2 participants |
| Placebo | Frequency and Intensity of Adverse Events | Moderate adverse events | 2 participants |
Secondary
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Assessed by a questionnaire completed by participants, addressing any feeling of the ring while the ring is in the body.
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Always | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Frequently | 1 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Occasionally | 5 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Never | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Always | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Frequently | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Occasionally | 2 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Occasionally | 6 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Never | 1 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Always | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Frequently | 1 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Frequently | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Never | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Occasionally | 2 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Never | 1 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Always | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Always | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Never | 1 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Occasionally | 2 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Frequently | 2 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Never | 2 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Occasionally | 3 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Frequently | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Always | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Never | 1 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Occasionally | 3 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Frequently | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Always | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Never | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Occasionally | 3 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Frequently | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Always | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Frequently | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Always | 1 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Never | 1 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Occasionally | 3 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Never | 3 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Never | 2 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Never | 2 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Frequently | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Frequently | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Occasionally | 4 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Always | 1 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Always | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Occasionally | 3 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Frequently | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Occasionally | 4 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Always | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Frequently | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Always | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Frequently | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Never | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Occasionally | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Occasionally | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Frequently | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Occasionally | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 3 | Always | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Never | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Never | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Never | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 1 | Always | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 4 | Always | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Occasionally | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring | Cycle 2 | Frequently | 0 Participants |
Secondary
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Assessed by a questionnaire completed by participants, addressing ring insertion
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Easy | 2 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Easy | 5 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Easy | 1 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Easy | 3 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Easier than the previous ring | 3 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Easier than the previous ring | 1 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Not Applicable (I was not given a new ring) | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Not Applicable (I was not given a new ring) | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Difficult | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Easier than the previous ring | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Difficult | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Easier than the previous ring | 1 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Not Applicable (I was not given a new ring) | 2 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Not Applicable (I was not given a new ring) | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Difficult | 1 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Difficult | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Difficult | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Easy | 2 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Easier than the previous ring | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Not Applicable (I was not given a new ring) | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Difficult | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Not Applicable (I was not given a new ring) | 1 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Easy | 4 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Easier than the previous ring | 1 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Easier than the previous ring | 2 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Difficult | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Not Applicable (I was not given a new ring) | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Easy | 3 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Easy | 4 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Easier than the previous ring | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Difficult | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Not Applicable (I was not given a new ring) | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Easy | 7 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Easy | 4 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Easy | 5 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Not Applicable (I was not given a new ring) | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Not Applicable (I was not given a new ring) | 1 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Easy | 6 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Easier than the previous ring | 1 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Not Applicable (I was not given a new ring) | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Difficult | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Easier than the previous ring | 1 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Difficult | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Easier than the previous ring | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Easier than the previous ring | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Difficult | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Not Applicable (I was not given a new ring) | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Difficult | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Not Applicable (I was not given a new ring) | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Easy | 2 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Easier than the previous ring | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Difficult | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 1 | Not Applicable (I was not given a new ring) | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Easy | 2 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Easier than the previous ring | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Difficult | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 2 | Not Applicable (I was not given a new ring) | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Easy | 2 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Easier than the previous ring | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Difficult | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 3 | Not Applicable (I was not given a new ring) | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Easy | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Easier than the previous ring | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring | Cycle 4 | Difficult | 0 Participants |
Secondary
Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring
Assessed by a questionnaire completed by participants, addressing ring removal.
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 1 | Easy | 6 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 1 | Difficult | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 2 | Easy | 6 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 2 | Difficult | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 3 | Easy | 4 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 3 | Difficult | 0 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 4 | Easy | 3 Participants |
| Quinagolide 360 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 4 | Difficult | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 3 | Difficult | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 3 | Easy | 4 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 1 | Difficult | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 4 | Difficult | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 4 | Easy | 3 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 2 | Difficult | 0 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 2 | Easy | 5 Participants |
| Quinagolide 720 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 1 | Easy | 5 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 4 | Easy | 5 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 2 | Easy | 7 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 2 | Difficult | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 3 | Easy | 6 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 3 | Difficult | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 4 | Difficult | 0 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 1 | Easy | 6 Participants |
| Quinagolide 1080 µg | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 1 | Difficult | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 2 | Easy | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 2 | Difficult | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 1 | Difficult | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 1 | Easy | 2 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 3 | Easy | 2 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 4 | Difficult | 0 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 4 | Easy | 1 Participants |
| Placebo | Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring | Cycle 3 | Difficult | 0 Participants |
Secondary
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
The participants recorded daily if they had sexual intercourse, in an e-diary. For the days when participants did not have intercourse, the participant recorded if the reason for not having intercourse was because they expected pain: Yes (I did not have intercourse this day, because I expected pain) or No (I did not have intercourse this day, but this was not because I expected pain). The numbers represent the cumulative number of days with no intercourse, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinagolide 360 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Baseline - Yes | 36 Number of days |
| Quinagolide 360 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 1 - Yes | 38 Number of days |
| Quinagolide 360 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Baseline - No | 103 Number of days |
| Quinagolide 360 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 1 - No | 116 Number of days |
| Quinagolide 360 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 2 - Yes | 34 Number of days |
| Quinagolide 360 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 2 - No | 107 Number of days |
| Quinagolide 360 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 3 - Yes | 30 Number of days |
| Quinagolide 360 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 3 - No | 112 Number of days |
| Quinagolide 360 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 4 - No | 94 Number of days |
| Quinagolide 360 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 4 - Yes | 29 Number of days |
| Quinagolide 720 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 4 - Yes | 11 Number of days |
| Quinagolide 720 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 1 - Yes | 20 Number of days |
| Quinagolide 720 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 3 - No | 106 Number of days |
| Quinagolide 720 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 1 - No | 107 Number of days |
| Quinagolide 720 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 2 - Yes | 13 Number of days |
| Quinagolide 720 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 2 - No | 109 Number of days |
| Quinagolide 720 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 3 - Yes | 23 Number of days |
| Quinagolide 720 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 4 - No | 67 Number of days |
| Quinagolide 720 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Baseline - Yes | 46 Number of days |
| Quinagolide 720 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Baseline - No | 94 Number of days |
| Quinagolide 1080 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 3 - No | 122 Number of days |
| Quinagolide 1080 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 2 - Yes | 29 Number of days |
| Quinagolide 1080 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 4 - Yes | 28 Number of days |
| Quinagolide 1080 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 4 - No | 117 Number of days |
| Quinagolide 1080 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 2 - No | 153 Number of days |
| Quinagolide 1080 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 3 - Yes | 31 Number of days |
| Quinagolide 1080 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Baseline - No | 154 Number of days |
| Quinagolide 1080 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Baseline - Yes | 41 Number of days |
| Quinagolide 1080 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 1 - Yes | 35 Number of days |
| Quinagolide 1080 µg | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 1 - No | 158 Number of days |
| Placebo | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 1 - Yes | 22 Number of days |
| Placebo | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Baseline - Yes | 24 Number of days |
| Placebo | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 3 - Yes | 1 Number of days |
| Placebo | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 2 - Yes | 11 Number of days |
| Placebo | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Baseline - No | 48 Number of days |
| Placebo | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 3 - No | 51 Number of days |
| Placebo | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 1 - No | 28 Number of days |
| Placebo | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 2 - No | 40 Number of days |
| Placebo | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 4 - Yes | 3 Number of days |
| Placebo | Frequency of Avoiding Sexual Intercourse Due to Expected Pain | Cycle 4 - No | 64 Number of days |
Secondary
Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml)
Assessed by blood samples collection
Time frame: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Quinagolide 360 µg | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Baseline | < 7.9 | 2 Participants |
| Quinagolide 360 µg | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Baseline | >= 7.9 | 4 Participants |
| Quinagolide 360 µg | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Cycle 4 | < 7.9 | 3 Participants |
| Quinagolide 360 µg | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Cycle 4 | >= 7.9 | 2 Participants |
| Quinagolide 720 µg | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Baseline | >= 7.9 | 3 Participants |
| Quinagolide 720 µg | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Cycle 4 | < 7.9 | 1 Participants |
| Quinagolide 720 µg | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Cycle 4 | >= 7.9 | 1 Participants |
| Quinagolide 720 µg | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Baseline | < 7.9 | 2 Participants |
| Quinagolide 1080 µg | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Cycle 4 | < 7.9 | 2 Participants |
| Quinagolide 1080 µg | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Baseline | >= 7.9 | 4 Participants |
| Quinagolide 1080 µg | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Cycle 4 | >= 7.9 | 3 Participants |
| Quinagolide 1080 µg | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Baseline | < 7.9 | 4 Participants |
| Placebo | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Cycle 4 | >= 7.9 | 0 Participants |
| Placebo | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Baseline | >= 7.9 | 2 Participants |
| Placebo | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Baseline | < 7.9 | 1 Participants |
| Placebo | Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml) | Cycle 4 | < 7.9 | 2 Participants |
Secondary
Patient Global Impression of Change (PGIC) Scores
Assessed by the PGIC scale completed by participants. PGIC is a 7-point scale depicting a patient's rating of their overall improvement from good to bad.
Time frame: At cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Minimally improved | 5 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Minimally improved | 4 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Minimally improved | 4 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Very much improved | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | No change | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Very much worse | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Much improved | 1 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Much improved | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Very much worse | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Minimally improved | 2 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Very much improved | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Very much improved | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Very much improved | 1 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Very much improved | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | No change | 1 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Very much improved | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Much improved | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Much improved | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | No change | 1 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Very much worse | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Minimally improved | 3 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | No change | 1 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Minimally improved | 3 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Much improved | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | No change | 1 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Very much worse | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Very much worse | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | No change | 1 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Very much worse | 0 Participants |
| Quinagolide 360 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Much improved | 2 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Very much worse | 0 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Minimally improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Very much improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Minimally improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Much improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Much improved | 0 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Minimally improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Very much worse | 0 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | No change | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Very much improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Very much improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Very much worse | 0 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Very much improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Very much worse | 0 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Much improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Much improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Minimally improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | No change | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | No change | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Very much improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Very much worse | 0 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Much improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Very much improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Very much worse | 0 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Much improved | 1 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Minimally improved | 2 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | No change | 2 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | No change | 0 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Minimally improved | 2 Participants |
| Quinagolide 720 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | No change | 0 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Very much improved | 0 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Very much improved | 0 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | No change | 0 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Very much worse | 1 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Much improved | 2 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Minimally improved | 4 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Very much worse | 0 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Very much improved | 0 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Much improved | 2 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Minimally improved | 2 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | No change | 1 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Very much worse | 1 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Very much improved | 0 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Much improved | 2 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Minimally improved | 3 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | No change | 1 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Very much worse | 0 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Very much improved | 0 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Much improved | 2 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Minimally improved | 3 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | No change | 1 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Very much worse | 0 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Very much improved | 0 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Much improved | 2 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Minimally improved | 3 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | No change | 0 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Very much worse | 1 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Much improved | 2 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Minimally improved | 3 Participants |
| Quinagolide 1080 µg | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | No change | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Very much improved | 2 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Very much worse | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Much improved | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Minimally improved | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | No change | 1 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Minimally improved | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Very much improved | 2 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | No change | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Much improved | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change of non-menstrual pelvic pain | Very much improved | 1 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Minimally improved | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Very much worse | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Very much worse | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | No change | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Minimally improved | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Very much improved | 2 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Much improved | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in dysmenorrhea | Very much improved | 2 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | No change | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Much improved | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | Very much worse | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain | No change | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Very much worse | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | No change | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Very much worse | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Very much improved | 2 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Minimally improved | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in the overall impact of endometriosis-related pain on daily activities | Much improved | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in the endometriosis related pain impact during non-menstrual periods | Minimally improved | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) Scores | Change in endometriosis-related pain impact during their menstrual periods | Much improved | 0 Participants |
Secondary
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Assessed daily by participants in an e-Diary
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 3 - Any analgesics | 39.67 percentage of days | Standard Deviation 40.008 |
| Quinagolide 360 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 3 - Mild analgesics | 38.00 percentage of days | Standard Deviation 36.92 |
| Quinagolide 360 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 2 - Mild analgesics | 40.96 percentage of days | Standard Deviation 37.699 |
| Quinagolide 360 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 3 - Strong analgesics | 10.83 percentage of days | Standard Deviation 24.224 |
| Quinagolide 360 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 4 - Strong analgesics | 9.17 percentage of days | Standard Deviation 20.497 |
| Quinagolide 360 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 1 - Mild analgesics | 41.68 percentage of days | Standard Deviation 31.961 |
| Quinagolide 360 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 1 - Strong analgesics | 10.75 percentage of days | Standard Deviation 22.649 |
| Quinagolide 360 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 4 - Mild analgesics | 39.88 percentage of days | Standard Deviation 35.135 |
| Quinagolide 360 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 2 - Any analgesics | 40.96 percentage of days | Standard Deviation 37.699 |
| Quinagolide 360 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 1 - Any analgesics | 41.68 percentage of days | Standard Deviation 31.961 |
| Quinagolide 360 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 2 - Strong analgesics | 12.35 percentage of days | Standard Deviation 30.241 |
| Quinagolide 360 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 4 - Any analgesics | 39.88 percentage of days | Standard Deviation 35.135 |
| Quinagolide 720 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 4 - Mild analgesics | 1.39 percentage of days | Standard Deviation 2.406 |
| Quinagolide 720 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 3 - Any analgesics | 32.25 percentage of days | Standard Deviation 44.036 |
| Quinagolide 720 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 2 - Mild analgesics | 21.00 percentage of days | Standard Deviation 44.215 |
| Quinagolide 720 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 3 - Strong analgesics | 10.13 percentage of days | Standard Deviation 13.88 |
| Quinagolide 720 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 2 - Strong analgesics | 10.99 percentage of days | Standard Deviation 14.572 |
| Quinagolide 720 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 3 - Mild analgesics | 29.47 percentage of days | Standard Deviation 46.115 |
| Quinagolide 720 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 1 - Strong analgesics | 5.12 percentage of days | Standard Deviation 7.976 |
| Quinagolide 720 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 4 - Any analgesics | 5.93 percentage of days | Standard Deviation 6.988 |
| Quinagolide 720 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 1 - Any analgesics | 26.04 percentage of days | Standard Deviation 41.912 |
| Quinagolide 720 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 2 - Any analgesics | 25.33 percentage of days | Standard Deviation 42.31 |
| Quinagolide 720 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 1 - Mild analgesics | 22.41 percentage of days | Standard Deviation 43.522 |
| Quinagolide 720 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 4 - Strong analgesics | 4.55 percentage of days | Standard Deviation 7.873 |
| Quinagolide 1080 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 3 - Mild analgesics | 38.62 percentage of days | Standard Deviation 44.213 |
| Quinagolide 1080 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 2 - Mild analgesics | 36.29 percentage of days | Standard Deviation 39.131 |
| Quinagolide 1080 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 1 - Any analgesics | 44.82 percentage of days | Standard Deviation 35.052 |
| Quinagolide 1080 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 1 - Mild analgesics | 44.82 percentage of days | Standard Deviation 35.052 |
| Quinagolide 1080 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 1 - Strong analgesics | 3.43 percentage of days | Standard Deviation 9.071 |
| Quinagolide 1080 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 2 - Any analgesics | 36.29 percentage of days | Standard Deviation 39.131 |
| Quinagolide 1080 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 2 - Strong analgesics | 2.86 percentage of days | Standard Deviation 7.559 |
| Quinagolide 1080 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 3 - Any analgesics | 38.62 percentage of days | Standard Deviation 44.213 |
| Quinagolide 1080 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 3 - Strong analgesics | 5.17 percentage of days | Standard Deviation 12.67 |
| Quinagolide 1080 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 4 - Any analgesics | 37.75 percentage of days | Standard Deviation 44.143 |
| Quinagolide 1080 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 4 - Mild analgesics | 37.75 percentage of days | Standard Deviation 44.143 |
| Quinagolide 1080 µg | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 4 - Strong analgesics | 3.47 percentage of days | Standard Deviation 8.505 |
| Placebo | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 2 - Strong analgesics | 0 percentage of days | Standard Deviation 0 |
| Placebo | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 2 - Any analgesics | 20.37 percentage of days | Standard Deviation 28.808 |
| Placebo | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 2 - Mild analgesics | 20.37 percentage of days | Standard Deviation 28.808 |
| Placebo | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 4 - Any analgesics | 2.56 percentage of days | Standard Deviation 3.626 |
| Placebo | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 1 - Strong analgesics | 0 percentage of days | Standard Deviation 0 |
| Placebo | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 1 - Mild analgesics | 3.57 percentage of days | Standard Deviation 5.051 |
| Placebo | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 4 - Strong analgesics | 0 percentage of days | Standard Deviation 0 |
| Placebo | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 4 - Mild analgesics | 2.56 percentage of days | Standard Deviation 3.626 |
| Placebo | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 3 - Mild analgesics | 13.46 percentage of days | Standard Deviation 13.598 |
| Placebo | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 3 - Any analgesics | 13.46 percentage of days | Standard Deviation 13.598 |
| Placebo | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 1 - Any analgesics | 3.57 percentage of days | Standard Deviation 5.051 |
| Placebo | Percentage of Days With Mild and/or Strong Rescue Analgesics Used | Cycle 3 - Strong analgesics | 0 percentage of days | Standard Deviation 0 |
Secondary
Plasma Concentration of Quinagolide and Metabolites
Assessed by blood samples collection
Time frame: Within 5 days after first ring insertion and at around 1 month, 3 months, 3.5 months and 4 months after baseline (each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Plasma Concentration of Quinagolide and Metabolites | Within 1-5 days of first ring inserting | 3.04 pg/mL | Standard Deviation 1.09 |
| Quinagolide 360 µg | Plasma Concentration of Quinagolide and Metabolites | Luteinizing hormone surge + 7 days visit during cycle 1 | 1.84 pg/mL | Standard Deviation 1.31 |
| Quinagolide 360 µg | Plasma Concentration of Quinagolide and Metabolites | Return of Menses + 7 days visit during cycle 1 | 1.22 pg/mL | Standard Deviation 0.632 |
| Quinagolide 360 µg | Plasma Concentration of Quinagolide and Metabolites | Return of Menses+7 days visit during cycle 3 | 1.44 pg/mL | Standard Deviation 0.578 |
| Quinagolide 360 µg | Plasma Concentration of Quinagolide and Metabolites | Luteinizing hormone surge + 7 days visit during cycle 4 | 2.08 pg/mL | Standard Deviation 0.65 |
| Quinagolide 360 µg | Plasma Concentration of Quinagolide and Metabolites | Return of Menses+7 days visit during cycle 4 | 1.47 pg/mL | Standard Deviation 0.799 |
| Quinagolide 720 µg | Plasma Concentration of Quinagolide and Metabolites | Return of Menses+7 days visit during cycle 4 | 2.07 pg/mL | Standard Deviation 0.85 |
| Quinagolide 720 µg | Plasma Concentration of Quinagolide and Metabolites | Within 1-5 days of first ring inserting | 7.77 pg/mL | Standard Deviation 3.94 |
| Quinagolide 720 µg | Plasma Concentration of Quinagolide and Metabolites | Return of Menses+7 days visit during cycle 3 | 2.00 pg/mL | Standard Deviation 0.98 |
| Quinagolide 720 µg | Plasma Concentration of Quinagolide and Metabolites | Luteinizing hormone surge + 7 days visit during cycle 4 | 2.92 pg/mL | — |
| Quinagolide 720 µg | Plasma Concentration of Quinagolide and Metabolites | Luteinizing hormone surge + 7 days visit during cycle 1 | 2.36 pg/mL | Standard Deviation 0.75 |
| Quinagolide 720 µg | Plasma Concentration of Quinagolide and Metabolites | Return of Menses + 7 days visit during cycle 1 | 1.52 pg/mL | Standard Deviation 0.54 |
| Quinagolide 1080 µg | Plasma Concentration of Quinagolide and Metabolites | Luteinizing hormone surge + 7 days visit during cycle 1 | 7.10 pg/mL | Standard Deviation 2.36 |
| Quinagolide 1080 µg | Plasma Concentration of Quinagolide and Metabolites | Return of Menses + 7 days visit during cycle 1 | 3.22 pg/mL | Standard Deviation 1.7 |
| Quinagolide 1080 µg | Plasma Concentration of Quinagolide and Metabolites | Return of Menses+7 days visit during cycle 4 | 3.41 pg/mL | Standard Deviation 2.43 |
| Quinagolide 1080 µg | Plasma Concentration of Quinagolide and Metabolites | Return of Menses+7 days visit during cycle 3 | 5.70 pg/mL | Standard Deviation 5.55 |
| Quinagolide 1080 µg | Plasma Concentration of Quinagolide and Metabolites | Within 1-5 days of first ring inserting | 10.5 pg/mL | Standard Deviation 8.79 |
| Quinagolide 1080 µg | Plasma Concentration of Quinagolide and Metabolites | Luteinizing hormone surge + 7 days visit during cycle 4 | 5.13 pg/mL | Standard Deviation 2.91 |
Secondary
Proportion of Subjects Identified With Potential Impulse Control Disorders
Assessed by the questionnaire for impulsive-compulsive disorders completed by participants. Measured at cycle 4.
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quinagolide 360 µg | Proportion of Subjects Identified With Potential Impulse Control Disorders | 1 Participants |
| Quinagolide 720 µg | Proportion of Subjects Identified With Potential Impulse Control Disorders | 0 Participants |
| Quinagolide 1080 µg | Proportion of Subjects Identified With Potential Impulse Control Disorders | 0 Participants |
| Placebo | Proportion of Subjects Identified With Potential Impulse Control Disorders | 0 Participants |
Secondary
Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease
Assessed by echocardiography. Each echocardiography was to be assessed as normal or abnormal according to American College of Cardiology/American Heart Association guidelines for valvular heart disease. If abnormal, the level of valvular regurgitation and valvular stenosis was specified as mild, moderate or severe and valvular structure was evaluated as well. Measured at cycle 4.
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quinagolide 360 µg | Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease | 0 Participants |
| Quinagolide 720 µg | Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease | 0 Participants |
| Quinagolide 1080 µg | Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease | 0 Participants |
| Placebo | Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease | 0 Participants |
Secondary
Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quinagolide 360 µg | Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters | 0 Participants |
| Quinagolide 720 µg | Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters | 0 Participants |
| Quinagolide 1080 µg | Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters | 0 Participants |
| Placebo | Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters | 0 Participants |
Secondary
Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters
Assessed by blood samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quinagolide 360 µg | Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters | 0 Participants |
| Quinagolide 720 µg | Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters | 0 Participants |
| Quinagolide 1080 µg | Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters | 0 Participants |
| Placebo | Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters | 0 Participants |
Secondary
Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters
Assessed by urine samples collection
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Quinagolide 360 µg | Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters | 0 Participants |
| Quinagolide 720 µg | Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters | 0 Participants |
| Quinagolide 1080 µg | Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters | 0 Participants |
| Placebo | Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters | 0 Participants |
Secondary
Responder Rate
Assessed as ≥30%, ≥50% and ≥70% reduction from the baseline in mean daily NRS score for the worst endometriosis-related pain, dysmenorrhea and non-menstrual pelvic pain and for the worst endometriosis-related pain impact
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinagolide 360 µg | Responder Rate | ≥50% reduction - non-menstrual pelvic pain | 20.0 percentage of participants |
| Quinagolide 360 µg | Responder Rate | ≥50% reduction - dysmenorrhea | 0 percentage of participants |
| Quinagolide 360 µg | Responder Rate | ≥30% reduction - impact on the subject's ability to function | 20.0 percentage of participants |
| Quinagolide 360 µg | Responder Rate | ≥70% reduction - non-menstrual pelvic pain | 0 percentage of participants |
| Quinagolide 360 µg | Responder Rate | ≥50% reduction - endometriosis-related pain | 0 percentage of participants |
| Quinagolide 360 µg | Responder Rate | ≥70% reduction - dysmenorrhea | 0 percentage of participants |
| Quinagolide 360 µg | Responder Rate | ≥30% reduction - dysmenorrhea | 0 percentage of participants |
| Quinagolide 360 µg | Responder Rate | ≥30% reduction - endometriosis-related pain | 20.0 percentage of participants |
| Quinagolide 360 µg | Responder Rate | ≥70% reduction - endometriosis-related pain | 0 percentage of participants |
| Quinagolide 360 µg | Responder Rate | ≥50% reduction - impact on the subject's ability to function | 0 percentage of participants |
| Quinagolide 360 µg | Responder Rate | ≥30% reduction - non-menstrual pelvic pain | 20.0 percentage of participants |
| Quinagolide 360 µg | Responder Rate | ≥70% reduction - impact on the subject's ability to function | 0 percentage of participants |
| Quinagolide 720 µg | Responder Rate | ≥70% reduction - endometriosis-related pain | 0 percentage of participants |
| Quinagolide 720 µg | Responder Rate | ≥30% reduction - endometriosis-related pain | 50.0 percentage of participants |
| Quinagolide 720 µg | Responder Rate | ≥30% reduction - dysmenorrhea | 75.0 percentage of participants |
| Quinagolide 720 µg | Responder Rate | ≥30% reduction - non-menstrual pelvic pain | 50.0 percentage of participants |
| Quinagolide 720 µg | Responder Rate | ≥30% reduction - impact on the subject's ability to function | 50.0 percentage of participants |
| Quinagolide 720 µg | Responder Rate | ≥50% reduction - endometriosis-related pain | 25.0 percentage of participants |
| Quinagolide 720 µg | Responder Rate | ≥50% reduction - dysmenorrhea | 50.0 percentage of participants |
| Quinagolide 720 µg | Responder Rate | ≥50% reduction - non-menstrual pelvic pain | 25.0 percentage of participants |
| Quinagolide 720 µg | Responder Rate | ≥50% reduction - impact on the subject's ability to function | 50.0 percentage of participants |
| Quinagolide 720 µg | Responder Rate | ≥70% reduction - dysmenorrhea | 25.0 percentage of participants |
| Quinagolide 720 µg | Responder Rate | ≥70% reduction - non-menstrual pelvic pain | 25.0 percentage of participants |
| Quinagolide 720 µg | Responder Rate | ≥70% reduction - impact on the subject's ability to function | 25.0 percentage of participants |
| Quinagolide 1080 µg | Responder Rate | ≥50% reduction - dysmenorrhea | 33.3 percentage of participants |
| Quinagolide 1080 µg | Responder Rate | ≥30% reduction - non-menstrual pelvic pain | 33.3 percentage of participants |
| Quinagolide 1080 µg | Responder Rate | ≥50% reduction - non-menstrual pelvic pain | 33.3 percentage of participants |
| Quinagolide 1080 µg | Responder Rate | ≥50% reduction - impact on the subject's ability to function | 33.3 percentage of participants |
| Quinagolide 1080 µg | Responder Rate | ≥30% reduction - dysmenorrhea | 50.0 percentage of participants |
| Quinagolide 1080 µg | Responder Rate | ≥70% reduction - endometriosis-related pain | 16.7 percentage of participants |
| Quinagolide 1080 µg | Responder Rate | ≥70% reduction - dysmenorrhea | 16.7 percentage of participants |
| Quinagolide 1080 µg | Responder Rate | ≥30% reduction - endometriosis-related pain | 33.3 percentage of participants |
| Quinagolide 1080 µg | Responder Rate | ≥30% reduction - impact on the subject's ability to function | 33.3 percentage of participants |
| Quinagolide 1080 µg | Responder Rate | ≥70% reduction - impact on the subject's ability to function | 16.7 percentage of participants |
| Quinagolide 1080 µg | Responder Rate | ≥50% reduction - endometriosis-related pain | 33.3 percentage of participants |
| Quinagolide 1080 µg | Responder Rate | ≥70% reduction - non-menstrual pelvic pain | 16.7 percentage of participants |
| Placebo | Responder Rate | ≥30% reduction - endometriosis-related pain | 100 percentage of participants |
| Placebo | Responder Rate | ≥50% reduction - dysmenorrhea | 100 percentage of participants |
| Placebo | Responder Rate | ≥70% reduction - impact on the subject's ability to function | 0 percentage of participants |
| Placebo | Responder Rate | ≥70% reduction - non-menstrual pelvic pain | 0 percentage of participants |
| Placebo | Responder Rate | ≥30% reduction - non-menstrual pelvic pain | 100 percentage of participants |
| Placebo | Responder Rate | ≥50% reduction - non-menstrual pelvic pain | 50.0 percentage of participants |
| Placebo | Responder Rate | ≥30% reduction - dysmenorrhea | 100 percentage of participants |
| Placebo | Responder Rate | ≥70% reduction - endometriosis-related pain | 0 percentage of participants |
| Placebo | Responder Rate | ≥70% reduction - dysmenorrhea | 0 percentage of participants |
| Placebo | Responder Rate | ≥50% reduction - impact on the subject's ability to function | 50.0 percentage of participants |
| Placebo | Responder Rate | ≥50% reduction - endometriosis-related pain | 50.0 percentage of participants |
| Placebo | Responder Rate | ≥30% reduction - impact on the subject's ability to function | 100 percentage of participants |
Secondary
Serum Levels of Estradiol
Assessed by blood samples collection
Time frame: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Serum Levels of Estradiol | Baseline | 328.2 pmol/L | Standard Deviation 105.46 |
| Quinagolide 360 µg | Serum Levels of Estradiol | Cycle 4 | 415.6 pmol/L | Standard Deviation 84.52 |
| Quinagolide 720 µg | Serum Levels of Estradiol | Cycle 4 | 278.8 pmol/L | Standard Deviation 229.21 |
| Quinagolide 720 µg | Serum Levels of Estradiol | Baseline | 534.4 pmol/L | Standard Deviation 215.68 |
| Quinagolide 1080 µg | Serum Levels of Estradiol | Baseline | 350.0 pmol/L | Standard Deviation 141.05 |
| Quinagolide 1080 µg | Serum Levels of Estradiol | Cycle 4 | 552.3 pmol/L | Standard Deviation 267.16 |
| Placebo | Serum Levels of Estradiol | Baseline | 431.6 pmol/L | Standard Deviation 67.41 |
| Placebo | Serum Levels of Estradiol | Cycle 4 | 142.8 pmol/L | Standard Deviation 10.9 |
Secondary
Serum Levels of Insulin-like Growth Factor-1 (IGF-1)
Assessed by blood samples collection
Time frame: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) | Baseline | 216.7 ng/mL | Standard Deviation 50.11 |
| Quinagolide 360 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) | Cycle 4 | 211.5 ng/mL | Standard Deviation 38.37 |
| Quinagolide 720 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) | Cycle 4 | 208.3 ng/mL | Standard Deviation 142.27 |
| Quinagolide 720 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) | Baseline | 221.1 ng/mL | Standard Deviation 89.37 |
| Quinagolide 1080 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) | Baseline | 166.2 ng/mL | Standard Deviation 59.58 |
| Quinagolide 1080 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) | Cycle 4 | 158.1 ng/mL | Standard Deviation 53.32 |
| Placebo | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) | Baseline | 188.7 ng/mL | Standard Deviation 12.57 |
| Placebo | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) | Cycle 4 | 169.9 ng/mL | Standard Deviation 12.73 |
Secondary
Serum Levels of Mid-luteal Phase Progesterone
Assessed by blood samples collection
Time frame: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Serum Levels of Mid-luteal Phase Progesterone | Baseline | 8.29 ng/mL | Standard Deviation 4.984 |
| Quinagolide 360 µg | Serum Levels of Mid-luteal Phase Progesterone | Cycle 4 | 9.55 ng/mL | Standard Deviation 7.389 |
| Quinagolide 720 µg | Serum Levels of Mid-luteal Phase Progesterone | Cycle 4 | 6.00 ng/mL | Standard Deviation 6.505 |
| Quinagolide 720 µg | Serum Levels of Mid-luteal Phase Progesterone | Baseline | 8.49 ng/mL | Standard Deviation 6.343 |
| Quinagolide 1080 µg | Serum Levels of Mid-luteal Phase Progesterone | Baseline | 7.04 ng/mL | Standard Deviation 6.014 |
| Quinagolide 1080 µg | Serum Levels of Mid-luteal Phase Progesterone | Cycle 4 | 6.56 ng/mL | Standard Deviation 6.382 |
| Placebo | Serum Levels of Mid-luteal Phase Progesterone | Baseline | 8.57 ng/mL | Standard Deviation 1.537 |
| Placebo | Serum Levels of Mid-luteal Phase Progesterone | Cycle 4 | 0.05 ng/mL | Standard Deviation 0 |
Secondary
Serum Levels of Prolactin
Assessed by blood samples collection
Time frame: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Serum Levels of Prolactin | Baseline | 8.0 ng/mL | Standard Deviation 2.4 |
| Quinagolide 360 µg | Serum Levels of Prolactin | Cycle 4 | 10.7 ng/mL | Standard Deviation 5.04 |
| Quinagolide 720 µg | Serum Levels of Prolactin | Cycle 4 | 11.3 ng/mL | Standard Deviation 2.97 |
| Quinagolide 720 µg | Serum Levels of Prolactin | Baseline | 13.2 ng/mL | Standard Deviation 8.25 |
| Quinagolide 1080 µg | Serum Levels of Prolactin | Baseline | 10.0 ng/mL | Standard Deviation 2.95 |
| Quinagolide 1080 µg | Serum Levels of Prolactin | Cycle 4 | 9.0 ng/mL | Standard Deviation 2.5 |
| Placebo | Serum Levels of Prolactin | Baseline | 13.4 ng/mL | Standard Deviation 0.69 |
| Placebo | Serum Levels of Prolactin | Cycle 4 | 35.7 ng/mL | Standard Deviation 20.22 |
Secondary
Serum Levels of Thyrotropin (TSH)
Assessed by blood samples collection
Time frame: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Serum Levels of Thyrotropin (TSH) | Cycle 4 | 1.7 uIU/mL | Standard Deviation 0.55 |
| Quinagolide 360 µg | Serum Levels of Thyrotropin (TSH) | Baseline | 1.9 uIU/mL | Standard Deviation 0.97 |
| Quinagolide 720 µg | Serum Levels of Thyrotropin (TSH) | Baseline | 2.1 uIU/mL | Standard Deviation 1.25 |
| Quinagolide 720 µg | Serum Levels of Thyrotropin (TSH) | Cycle 4 | 2.1 uIU/mL | Standard Deviation 1.17 |
| Quinagolide 1080 µg | Serum Levels of Thyrotropin (TSH) | Cycle 4 | 1.2 uIU/mL | Standard Deviation 0.78 |
| Quinagolide 1080 µg | Serum Levels of Thyrotropin (TSH) | Baseline | 1.3 uIU/mL | Standard Deviation 0.56 |
| Placebo | Serum Levels of Thyrotropin (TSH) | Baseline | 2.7 uIU/mL | Standard Deviation 2.14 |
| Placebo | Serum Levels of Thyrotropin (TSH) | Cycle 4 | 2.3 uIU/mL | — |
Secondary
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Assessed daily by participants in an e-Diary
Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 3 | 10360.0 mg | Standard Deviation 11802.03 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 1 | 325.10 mg | Standard Deviation 339.854 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 2 | 11266.7 mg | Standard Deviation 15184.03 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 2 | 443.41 mg | Standard Deviation 557.172 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 1 | 8400.0 mg | Standard Deviation 7740.8 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 3 | 412.97 mg | Standard Deviation 490.864 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 4 | 9760.0 mg | Standard Deviation 11939.35 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 4 | 403.73 mg | Standard Deviation 507.562 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 1 | 1575.8 mg | Standard Deviation 3431.31 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 1 | 66.93 mg | Standard Deviation 146.737 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 2 | 2541.7 mg | Standard Deviation 6225.79 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 2 | 94.42 mg | Standard Deviation 231.273 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 3 | 2013.0 mg | Standard Deviation 4501.2 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 3 | 79.38 mg | Standard Deviation 177.493 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 4 | 1159.0 mg | Standard Deviation 2591.6 |
| Quinagolide 360 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 4 | 46.14 mg | Standard Deviation 103.164 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 3 | 333.19 mg | Standard Deviation 497.634 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 1 | 427.0 mg | Standard Deviation 668.22 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 4 | 13.26 mg | Standard Deviation 22.968 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 2 | 36.03 mg | Standard Deviation 45.793 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 4 | 305.0 mg | Standard Deviation 528.28 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 1 | 18.38 mg | Standard Deviation 30.108 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 2 | 5480.0 mg | Standard Deviation 11594.48 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 2 | 854.0 mg | Standard Deviation 1086.93 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 3 | 10650.0 mg | Standard Deviation 17070.34 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 4 | 400.0 mg | Standard Deviation 692.82 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 2 | 230.28 mg | Standard Deviation 482.277 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 1 | 213.27 mg | Standard Deviation 420.629 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 3 | 1143.8 mg | Standard Deviation 1460.08 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 4 | 16.00 mg | Standard Deviation 27.713 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 3 | 36.55 mg | Standard Deviation 44.327 |
| Quinagolide 720 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 1 | 5680.0 mg | Standard Deviation 11389.12 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 3 | 590.77 mg | Standard Deviation 648.496 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 3 | 16166.7 mg | Standard Deviation 17716.17 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 3 | 54.34 mg | Standard Deviation 133.103 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 4 | 15333.3 mg | Standard Deviation 21142.44 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 4 | 606.03 mg | Standard Deviation 824.589 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 4 | 12.71 mg | Standard Deviation 31.129 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 1 | 697.1 mg | Standard Deviation 1844.47 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 1 | 27.89 mg | Standard Deviation 73.779 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 4 | 305.0 mg | Standard Deviation 747.09 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 2 | 915.0 mg | Standard Deviation 2420.86 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 2 | 30.50 mg | Standard Deviation 80.695 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 1 | 14514.3 mg | Standard Deviation 14920.17 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 1 | 613.51 mg | Standard Deviation 665.765 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 3 | 1575.8 mg | Standard Deviation 3859.99 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 2 | 13485.7 mg | Standard Deviation 17324.3 |
| Quinagolide 1080 µg | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 2 | 487.05 mg | Standard Deviation 613.429 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 4 | 0 mg | Standard Deviation 0 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 4 | 30.77 mg | Standard Deviation 43.514 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 2 | 8600.0 mg | Standard Deviation 12162.24 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 1 | 1200.0 mg | Standard Deviation 1697.06 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 3 | 0 mg | Standard Deviation 0 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 4 | 1200.0 mg | Standard Deviation 1697.06 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 3 | 0 mg | Standard Deviation 0 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 1 | 42.86 mg | Standard Deviation 60.609 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of mild analgesics - Cycle 3 | 5500.0 mg | Standard Deviation 6646.8 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 1 | 0 mg | Standard Deviation 0 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 3 | 211.54 mg | Standard Deviation 255.646 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 2 | 0 mg | Standard Deviation 0 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 4 | 0 mg | Standard Deviation 0 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Total dose of strong analgesics - Cycle 1 | 0 mg | Standard Deviation 0 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of mild analgesics - Cycle 2 | 318.52 mg | Standard Deviation 450.453 |
| Placebo | Total and Average Doses of Mild and/or Strong Rescue Analgesics Used | Average dose of strong analgesics - Cycle 2 | 0 mg | Standard Deviation 0 |
Secondary
Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity)
Assessed by urine sample collection (dip-stick test). Overall Urinalysis Result.
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Quinagolide 360 µg | Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity) | Abnormal overall urinalysis result | 0 Participants |
| Quinagolide 360 µg | Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity) | Normal overall urinalysis result | 1 Participants |
| Quinagolide 720 µg | Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity) | Normal overall urinalysis result | 1 Participants |
| Quinagolide 720 µg | Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity) | Abnormal overall urinalysis result | 0 Participants |
| Quinagolide 1080 µg | Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity) | Normal overall urinalysis result | 2 Participants |
| Quinagolide 1080 µg | Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity) | Abnormal overall urinalysis result | 0 Participants |
| Placebo | Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity) | Abnormal overall urinalysis result | 0 Participants |
| Placebo | Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity) | Normal overall urinalysis result | 2 Participants |