Endometriosis
Conditions
Keywords
Endometrioma, Adenomyosis, Deep infiltrating endometriosis
Brief summary
This will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or adenomyosis.
Interventions
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 45 Years
Healthy volunteers
No
Inclusion criteria
1. Pre-menopausal women between the ages 18-45 years (both inclusive) at the time of signing the informed consent 2. Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening 3. Confirmation of deep infiltrating endometriosis (DIE), endometrioma or adenomyosis by high-resolution MRI at screening 4. Transvaginal ultrasound (TVU) documenting a uterus with no abnormalities of endometrium and presence of at least one ovary with no clinically significant abnormalities at screening. Note that presence of uterine fibroids are not exclusionary but presence of any submucosal fibroids or polyps are exclusionary 5. Willing and able to use a non-hormonal single-barrier method (i.e. condom) for contraception from the start of screening to the end-of-treatment. This is not required if adequate contraception is achieved by vasectomy of the male sexual partner, surgical sterilisation (e.g. tubal ligation and blockage methods such as ESSURE) of the subject, or true abstinence of the subject (sporadic sexual intercourse with men requiring condom use) 6. Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices (except for tampons) from randomization to the end of treatment
Exclusion criteria
1. Use of depot medroxyprogesterone acetate (MPA) within 10 months prior to the screening visit. 2. Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists within 6 months prior to the screening visit. 3. Use of GnRH agonists (1-month depot or nasal spray), GnRH antagonists, aromatase inhibitors, danazol, birth control implants (e.g. NEXPLANON), progestogen or levonorgestrel releasing intrauterine device (IUD) within 3 months prior to the screening visit. 4. Use of hormonal contraceptives (including combined oral contraceptive pill, transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the screening visit. 5. Contraindications to MRI such as having internal/external metallic devices and/or accessories (e.g. cardiac pacemakers and leg braces)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. |
| Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. |
| Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. |
| Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. |
| Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4 | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4. |
| Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4 | At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days) | B&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs. In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3. In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3. The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E. The score can be between 0 and 15. |
| Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) | Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes: * during the last menstrual cycle * during the menstrual period of the last menstrual cycle * during the non-menstrual period of the last menstrual cycle |
| Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months) | EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always. |
| Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) | Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown. |
| Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) | Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown. |
| Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months) | Assessed by blood sample collection |
| Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months) | Assessed by blood sample collection |
| Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months) | Assessed by blood sample collection |
| Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4 | Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Hematocrit | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Platelets | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Leukocytes | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Albumin | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Bilirubin | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Calcium | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Chloride | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Cholesterol | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Creatinine | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Glucose | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Phosphate | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Potassium | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Sodium | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. |
| Changes in Clinical Chemistry and Hematology Parameters: Urate | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
| Frequency and Intensity of Adverse Events | From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days) | Assessed by and Adverse Event Log completed by the Investigator |
| Changes in Clinical Chemistry and Hematology Parameters: Protein | At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days) | Assessed by blood sample collection |
Countries
Denmark, Germany, Italy, Poland
Participant flow
Recruitment details
The trial was performed in 6 investigational sites in 3 countries between Aug 2019 to Jul 2021.
Pre-assignment details
In total, 147 subjects were screened. Of these, 80 were screening failures and 67 were randomized and exposed to the investigational medicinal product (IMP): 35 to Quinagolide and 32 to Placebo.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| Placebo Vaginal ring containing matching placebo
Placebo: Matching placebo | 32 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
Baseline characteristics
| Characteristic | Quinagolide 1080 µg | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 32 Participants | 67 Participants |
| Age, Continuous | 36.9 years STANDARD_DEVIATION 5.51 | 35.2 years STANDARD_DEVIATION 5.96 | 36.1 years STANDARD_DEVIATION 5.75 |
| Body Mass Index (BMI) | 23.91 kg/m^2 STANDARD_DEVIATION 3.86 | 23.30 kg/m^2 STANDARD_DEVIATION 4.15 | 23.62 kg/m^2 STANDARD_DEVIATION 3.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 32 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 32 Participants | 66 Participants |
| Sex: Female, Male Female | 35 Participants | 32 Participants | 67 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 32 |
| other Total, other adverse events | 20 / 35 | 20 / 32 |
| serious Total, serious adverse events | 1 / 35 | 0 / 32 |
Outcome results
Primary
Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis.
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 1080 µg | Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | Endometrioma | -0.20 mm | Standard Error 4.34 |
| Quinagolide 1080 µg | Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | DIE | 2.41 mm | Standard Error 2.52 |
| Quinagolide 1080 µg | Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | Adenomyosis | -3.10 mm | Standard Error 3.75 |
| Placebo | Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | Endometrioma | -1.94 mm | Standard Error 4.48 |
| Placebo | Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | DIE | -0.94 mm | Standard Error 2.03 |
| Placebo | Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 | Adenomyosis | -3.43 mm | Standard Error 3.87 |
Comparison: Endometriomap-value: 0.7895% CI: [-10.45, 13.94]ANCOVA
Comparison: DIEp-value: 0.2995% CI: [-2.89, 9.59]ANCOVA
Comparison: Adenomyosisp-value: 0.9595% CI: [-10.33, 10.99]ANCOVA
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase | -1.1 U/L | Standard Deviation 5.88 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase | -0.2 U/L | Standard Deviation 3.86 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Albumin
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Albumin | 0.0 g/L | Standard Deviation 2.28 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Albumin | 0.7 g/L | Standard Deviation 2.84 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase | 3.1 IU/L | Standard Deviation 8.18 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase | 4.2 IU/L | Standard Deviation 6.67 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase | 1.0 U/L | Standard Deviation 3.72 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase | 0.5 U/L | Standard Deviation 3.43 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate | -2.7 mmol/L | Standard Deviation 2.59 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate | -2.9 mmol/L | Standard Deviation 2.51 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Bilirubin
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Bilirubin | -1.2 umol/L | Standard Deviation 2.84 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Bilirubin | -0.8 umol/L | Standard Deviation 4.57 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Calcium
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Calcium | 0.009 mmol/L | Standard Deviation 0.0896 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Calcium | 0.012 mmol/L | Standard Deviation 0.0773 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Chloride
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Chloride | 0.2 mmol/L | Standard Deviation 2.68 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Chloride | -0.5 mmol/L | Standard Deviation 2.49 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Cholesterol
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Cholesterol | 0.045 mmol/L | Standard Deviation 0.505 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Cholesterol | 0.244 mmol/L | Standard Deviation 0.5219 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Creatinine
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Creatinine | -3.5 umol/L | Standard Deviation 8.21 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Creatinine | -4.3 umol/L | Standard Deviation 7.82 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin | 0.0 umol/L | Standard Deviation 0.38 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin | 0.0 umol/L | Standard Deviation 1.1 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin | -0.7 pg/cell | Standard Deviation 0.71 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin | -0.6 pg/cell | Standard Deviation 1.22 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration | -3.1 g/L | Standard Deviation 7.11 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration | -4.3 g/L | Standard Deviation 8.76 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume | -1.2 fL | Standard Deviation 2.11 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume | -0.7 fL | Standard Deviation 3.1 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes | -0.02 10^12 cells/L | Standard Deviation 0.192 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes | -0.01 10^12 cells/L | Standard Deviation 0.228 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase | -1.1 U/L | Standard Deviation 4.77 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase | 1.0 U/L | Standard Deviation 4.46 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Glucose
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Glucose | -0.07 mmol/L | Standard Deviation 0.734 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Glucose | -0.06 mmol/L | Standard Deviation 0.866 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin | -3.6 g/L | Standard Deviation 5.6 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin | -3.2 g/L | Standard Deviation 8.69 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Hematocrit
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Hematocrit | -0.007 % v/v | Standard Deviation 0.0181 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Hematocrit | -0.005 % v/v | Standard Deviation 0.0259 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase | 2.7 U/L | Standard Deviation 12.3 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase | 2.8 U/L | Standard Deviation 8.42 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Leukocytes
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Leukocytes | -0.43 10^9 cells/L | Standard Deviation 1.928 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Leukocytes | 0.18 10^9 cells/L | Standard Deviation 2.055 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Phosphate
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Phosphate | -0.013 mmol/L | Standard Deviation 0.1452 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Phosphate | 0.048 mmol/L | Standard Deviation 0.1885 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Platelets
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Platelets | 4.9 10^9 cells/L | Standard Deviation 33.98 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Platelets | 11.6 10^9 cells/L | Standard Deviation 45.92 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Potassium
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Potassium | 0.07 mmol/L | Standard Deviation 0.333 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Potassium | 0.06 mmol/L | Standard Deviation 0.357 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Protein
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Protein | -0.1 g/L | Standard Deviation 3.82 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Protein | 1.4 g/L | Standard Deviation 3.19 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Sodium
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Sodium | 0.7 mmol/L | Standard Deviation 2.04 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Sodium | 0.4 mmol/L | Standard Deviation 2.54 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Urate
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Urate | 10.7 umol/L | Standard Deviation 56.36 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Urate | 1.3 umol/L | Standard Deviation 37.59 |
Secondary
Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen | -0.180 mmol/L | Standard Deviation 1.0184 |
| Placebo | Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen | 0.148 mmol/L | Standard Deviation 1.2286 |
Secondary
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4
EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always.
Time frame: At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 1080 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | Endometrioma at cycle 2 | -46.6 Score on a scale | Standard Deviation 90.49 |
| Quinagolide 1080 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | Endometrioma at cycle 4 | -56.6 Score on a scale | Standard Deviation 88.84 |
| Quinagolide 1080 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | DIE at cycle 2 | -55.6 Score on a scale | Standard Deviation 91.14 |
| Quinagolide 1080 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | DIE at cycle 4 | -54.8 Score on a scale | Standard Deviation 87.29 |
| Quinagolide 1080 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | Adenomyosis at cycle 2 | -46.3 Score on a scale | Standard Deviation 102.92 |
| Quinagolide 1080 µg | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | Adenomyosis at cycle 4 | -64.9 Score on a scale | Standard Deviation 105.62 |
| Placebo | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | Adenomyosis at cycle 2 | -33.2 Score on a scale | Standard Deviation 52.21 |
| Placebo | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | Endometrioma at cycle 2 | -51.0 Score on a scale | Standard Deviation 71.6 |
| Placebo | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | DIE at cycle 4 | -85.7 Score on a scale | Standard Deviation 98.96 |
| Placebo | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | Endometrioma at cycle 4 | -94.0 Score on a scale | Standard Deviation 85.14 |
| Placebo | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | Adenomyosis at cycle 4 | -79.4 Score on a scale | Standard Deviation 90.04 |
| Placebo | Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 | DIE at cycle 2 | -41.7 Score on a scale | Standard Deviation 86.27 |
Comparison: Endometrioma at cycle 2p-value: 0.7595% CI: [-53.97, 39.27]ANCOVA
Comparison: Endometrioma at cycle 4p-value: 0.4295% CI: [-25.41, 60.04]ANCOVA
Comparison: DIE at cycle 2p-value: 0.4795% CI: [-66.3, 30.98]ANCOVA
Comparison: DIE at cycle 4p-value: 0.2795% CI: [-21.05, 72.27]ANCOVA
Comparison: Adenomyosis at cycle 2p-value: 0.4195% CI: [-71.83, 29.92]ANCOVA
Comparison: Adenomyosis at cycle 4p-value: 0.9395% CI: [-49.57, 54.06]ANCOVA
Secondary
Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4
B&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs. In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3. In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3. The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E. The score can be between 0 and 15.
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 1080 µg | Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4 | Endometrioma | -1.2 score on a scale | Standard Deviation 2.26 |
| Quinagolide 1080 µg | Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4 | DIE | -1.3 score on a scale | Standard Deviation 2.16 |
| Quinagolide 1080 µg | Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4 | Adenomyosis | -1.5 score on a scale | Standard Deviation 2.33 |
| Placebo | Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4 | Endometrioma | -2.1 score on a scale | Standard Deviation 2.51 |
| Placebo | Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4 | DIE | -1.6 score on a scale | Standard Deviation 2.21 |
| Placebo | Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4 | Adenomyosis | -1.9 score on a scale | Standard Deviation 1.86 |
Comparison: Endometriomap-value: 0.195% CI: [-0.2, 2.38]ANCOVA
Comparison: DIEp-value: 0.6795% CI: [-1.02, 1.58]ANCOVA
Comparison: Adenomyosisp-value: 0.6495% CI: [-1.06, 1.71]ANCOVA
Secondary
Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)
Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown.
Time frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Endometrioma at cycle 4 | 5.0 Days | Standard Deviation 1.43 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | DIE at cycle 3 | 4.5 Days | Standard Deviation 1.22 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Endometrioma at cycle 1 | 5.3 Days | Standard Deviation 1.71 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | DIE at cycle 4 | 5.2 Days | Standard Deviation 1.04 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | DIE at baseline | 4.9 Days | Standard Deviation 0.99 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Adenomyosis at baseline | 5.2 Days | Standard Deviation 1.2 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Endometrioma at cycle 3 | 4.5 Days | Standard Deviation 1.61 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Adenomyosis at cycle 1 | 5.0 Days | Standard Deviation 1.75 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | DIE at cycle 1 | 5.0 Days | Standard Deviation 1.6 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Adenomyosis at cycle 2 | 4.6 Days | Standard Deviation 1.78 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Endometrioma at cycle 2 | 5.3 Days | Standard Deviation 1.22 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Adenomyosis at cycle 3 | 4.3 Days | Standard Deviation 1.66 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | DIE at cycle 2 | 5.0 Days | Standard Deviation 1.82 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Adenomyosis at cycle 4 | 5.0 Days | Standard Deviation 0.74 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Endometrioma at baseline | 5.1 Days | Standard Deviation 1.08 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Adenomyosis at cycle 4 | 5.0 Days | Standard Deviation 1.32 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Endometrioma at baseline | 5.1 Days | Standard Deviation 0.97 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Endometrioma at cycle 1 | 4.7 Days | Standard Deviation 0.77 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Endometrioma at cycle 2 | 5.1 Days | Standard Deviation 0.87 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Endometrioma at cycle 3 | 4.8 Days | Standard Deviation 0.89 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Endometrioma at cycle 4 | 4.7 Days | Standard Deviation 1.52 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | DIE at baseline | 5.3 Days | Standard Deviation 1.01 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | DIE at cycle 1 | 4.6 Days | Standard Deviation 0.7 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | DIE at cycle 2 | 5.0 Days | Standard Deviation 1.04 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | DIE at cycle 3 | 4.9 Days | Standard Deviation 0.93 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | DIE at cycle 4 | 4.9 Days | Standard Deviation 1.6 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Adenomyosis at baseline | 5.4 Days | Standard Deviation 1.15 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Adenomyosis at cycle 1 | 4.9 Days | Standard Deviation 0.62 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Adenomyosis at cycle 2 | 4.8 Days | Standard Deviation 1.17 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) | Adenomyosis at cycle 3 | 4.7 Days | Standard Deviation 1.05 |
Secondary
Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)
Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown.
Time frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Endometrioma at cycle 4 | 28.2 Days | Standard Deviation 3.27 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | DIE at cycle 3 | 28.2 Days | Standard Deviation 2.86 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Endometrioma at cycle 1 | 27.8 Days | Standard Deviation 2.92 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | DIE at cycle 4 | 26.9 Days | Standard Deviation 2.23 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | DIE at baseline | 33.2 Days | Standard Deviation 11.8 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Adenomyosis at baseline | 33.5 Days | Standard Deviation 11.16 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Endometrioma at cycle 3 | 27.7 Days | Standard Deviation 2.12 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Adenomyosis at cycle 1 | 27.7 Days | Standard Deviation 2.54 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | DIE at cycle 1 | 26.7 Days | Standard Deviation 2.66 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Adenomyosis at cycle 2 | 28.3 Days | Standard Deviation 2.23 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Endometrioma at cycle 2 | 28.1 Days | Standard Deviation 2.13 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Adenomyosis at cycle 3 | 27.8 Days | Standard Deviation 2.52 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | DIE at cycle 2 | 27.4 Days | Standard Deviation 1.98 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Adenomyosis at cycle 4 | 27.2 Days | Standard Deviation 1.5 |
| Quinagolide 1080 µg | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Endometrioma at baseline | 31.9 Days | Standard Deviation 10.54 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Adenomyosis at cycle 4 | 27.4 Days | Standard Deviation 1.87 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Endometrioma at baseline | 32.6 Days | Standard Deviation 10.38 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Endometrioma at cycle 1 | 26.9 Days | Standard Deviation 2.39 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Endometrioma at cycle 2 | 27.4 Days | Standard Deviation 2.5 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Endometrioma at cycle 3 | 28.3 Days | Standard Deviation 2.65 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Endometrioma at cycle 4 | 26.9 Days | Standard Deviation 2.23 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | DIE at baseline | 31.4 Days | Standard Deviation 9.45 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | DIE at cycle 1 | 27.3 Days | Standard Deviation 2.78 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | DIE at cycle 2 | 27.7 Days | Standard Deviation 2.52 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | DIE at cycle 3 | 28.5 Days | Standard Deviation 2.29 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | DIE at cycle 4 | 27.7 Days | Standard Deviation 2.59 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Adenomyosis at baseline | 32.4 Days | Standard Deviation 11.49 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Adenomyosis at cycle 1 | 26.8 Days | Standard Deviation 2.61 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Adenomyosis at cycle 2 | 27.4 Days | Standard Deviation 2.37 |
| Placebo | Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) | Adenomyosis at cycle 3 | 27.9 Days | Standard Deviation 1.93 |
Secondary
Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4
Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes: * during the last menstrual cycle * during the menstrual period of the last menstrual cycle * during the non-menstrual period of the last menstrual cycle
Time frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 1080 µg | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Endometrioma at cycle 1 | -0.5 score on a scale | Standard Deviation 1.96 |
| Quinagolide 1080 µg | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Endometrioma at cycle 2 | -0.9 score on a scale | Standard Deviation 2.17 |
| Quinagolide 1080 µg | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Endometrioma at cycle 3 | -1.7 score on a scale | Standard Deviation 2.73 |
| Quinagolide 1080 µg | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Endometrioma at cycle 4 | -1.5 score on a scale | Standard Deviation 3.11 |
| Quinagolide 1080 µg | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | DIE at cycle 1 | -0.6 score on a scale | Standard Deviation 2.14 |
| Quinagolide 1080 µg | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | DIE at cycle 2 | -1.1 score on a scale | Standard Deviation 2.2 |
| Quinagolide 1080 µg | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | DIE at cycle 3 | -1.7 score on a scale | Standard Deviation 2.65 |
| Quinagolide 1080 µg | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | DIE at cycle 4 | -1.2 score on a scale | Standard Deviation 2.27 |
| Quinagolide 1080 µg | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Adenomyosis at cycle 1 | 0.3 score on a scale | Standard Deviation 1.84 |
| Quinagolide 1080 µg | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Adenomyosis at cycle 2 | -0.7 score on a scale | Standard Deviation 2.37 |
| Quinagolide 1080 µg | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Adenomyosis at cycle 3 | -0.8 score on a scale | Standard Deviation 2.34 |
| Quinagolide 1080 µg | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Adenomyosis at cycle 4 | -1.6 score on a scale | Standard Deviation 2.91 |
| Placebo | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Adenomyosis at cycle 3 | -0.9 score on a scale | Standard Deviation 1.78 |
| Placebo | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Endometrioma at cycle 1 | -0.7 score on a scale | Standard Deviation 2.21 |
| Placebo | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | DIE at cycle 3 | -1.0 score on a scale | Standard Deviation 1.97 |
| Placebo | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Endometrioma at cycle 2 | -1.1 score on a scale | Standard Deviation 2.85 |
| Placebo | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Adenomyosis at cycle 2 | -0.9 score on a scale | Standard Deviation 2.13 |
| Placebo | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Endometrioma at cycle 3 | -1.1 score on a scale | Standard Deviation 1.67 |
| Placebo | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | DIE at cycle 4 | -2.1 score on a scale | Standard Deviation 2.21 |
| Placebo | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Endometrioma at cycle 4 | -2.0 score on a scale | Standard Deviation 1.94 |
| Placebo | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Adenomyosis at cycle 4 | -1.9 score on a scale | Standard Deviation 2.28 |
| Placebo | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | DIE at cycle 1 | -0.7 score on a scale | Standard Deviation 2.19 |
| Placebo | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | Adenomyosis at cycle 1 | -0.7 score on a scale | Standard Deviation 2.24 |
| Placebo | Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 | DIE at cycle 2 | -1.4 score on a scale | Standard Deviation 2.97 |
Comparison: Endometrioma at cycle 1p-value: 0.7395% CI: [-1.02, 1.44]ANCOVA
Comparison: Endometrioma at cycle 2p-value: 0.5495% CI: [-0.97, 1.82]ANCOVA
Comparison: Endometrioma at cycle 3p-value: 0.4695% CI: [-1.86, 0.85]ANCOVA
Comparison: Endometrioma at cycle 4p-value: 0.4995% CI: [-0.99, 2.05]ANCOVA
Comparison: DIE at cycle 1p-value: 0.9995% CI: [-1.32, 1.3]ANCOVA
Comparison: DIE at cycle 2p-value: 0.8395% CI: [-1.38, 1.71]ANCOVA
Comparison: DIE at cycle 3p-value: 0.2895% CI: [-2.11, 0.63]ANCOVA
Comparison: DIE at cycle 4p-value: 0.2695% CI: [-0.57, 2.07]ANCOVA
Comparison: Adenomyosis at cycle 1p-value: 0.1995% CI: [-0.49, 2.31]ANCOVA
Comparison: Adenomyosis at cycle 2p-value: 0.9395% CI: [-1.45, 1.58]ANCOVA
Comparison: Adenomyosis at cycle 3p-value: 0.8595% CI: [-1.58, 1.32]ANCOVA
Comparison: Adenomyosis at cycle 4p-value: 0.9995% CI: [-1.68, 1.69]ANCOVA
Secondary
Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4
Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4.
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Quinagolide 1080 µg | Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4 | 14.19 mm | Standard Error 8.7 |
| Placebo | Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4 | 4.06 mm | Standard Error 9.02 |
p-value: 0.4295% CI: [-14.74, 35]ANCOVA
Secondary
Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, and 45 subjects in the DIE group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 1080 µg | Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4 | DIE | -0.15 mm^3 | Standard Error 1.81 |
| Quinagolide 1080 µg | Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4 | Endometrioma | 2.12 mm^3 | Standard Error 4.62 |
| Placebo | Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4 | Endometrioma | 1.89 mm^3 | Standard Error 4.77 |
| Placebo | Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4 | DIE | -0.87 mm^3 | Standard Error 1.25 |
Comparison: Endometriomap-value: 0.9795% CI: [-12.78, 13.23]ANCOVA
Comparison: DIEp-value: 0.7495% CI: [-3.63, 5.07]ANCOVA
Secondary
Frequency and Intensity of Adverse Events
Assessed by and Adverse Event Log completed by the Investigator
Time frame: From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinagolide 1080 µg | Frequency and Intensity of Adverse Events | Mild adverse events | 28.6 Percentage of subjects |
| Quinagolide 1080 µg | Frequency and Intensity of Adverse Events | Moderate adverse events | 42.9 Percentage of subjects |
| Quinagolide 1080 µg | Frequency and Intensity of Adverse Events | Severe adverse events | 2.9 Percentage of subjects |
| Placebo | Frequency and Intensity of Adverse Events | Mild adverse events | 43.8 Percentage of subjects |
| Placebo | Frequency and Intensity of Adverse Events | Moderate adverse events | 37.5 Percentage of subjects |
| Placebo | Frequency and Intensity of Adverse Events | Severe adverse events | 9.4 Percentage of subjects |
Secondary
Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinagolide 1080 µg | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | DIE - Disappearing Lesions | 0 Lesions |
| Quinagolide 1080 µg | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Endometrioma - Disappearing Lesions | 14 Lesions |
| Quinagolide 1080 µg | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Adenomyosis - Disappearing Lesions | 1 Lesions |
| Quinagolide 1080 µg | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Endometrioma - New Lesions | 3 Lesions |
| Quinagolide 1080 µg | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | DIE - New Lesions | 0 Lesions |
| Quinagolide 1080 µg | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Adenomyosis - New Lesions | 0 Lesions |
| Placebo | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | DIE - New Lesions | 0 Lesions |
| Placebo | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Endometrioma - New Lesions | 3 Lesions |
| Placebo | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Endometrioma - Disappearing Lesions | 5 Lesions |
| Placebo | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | DIE - Disappearing Lesions | 1 Lesions |
| Placebo | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Adenomyosis - New Lesions | 0 Lesions |
| Placebo | Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Adenomyosis - Disappearing Lesions | 2 Lesions |
Comparison: Endometrioma - Disappearing Lesionsp-value: 0.1395% CI: [0.76, 8.39]Negative-binomial regression
Comparison: Adenomyosis - Disappearing Lesionsp-value: 0.5695% CI: [0.04, 5.41]Negative-binomial regression
Secondary
Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 1080 µg | Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Endometrioma | 15.64 Percentage of changes in the size | Standard Deviation 70.12 |
| Quinagolide 1080 µg | Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | DIE | 7.67 Percentage of changes in the size | Standard Deviation 15.22 |
| Quinagolide 1080 µg | Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Adenomyosis | -3.04 Percentage of changes in the size | Standard Deviation 32.31 |
| Placebo | Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Endometrioma | -6.83 Percentage of changes in the size | Standard Deviation 44.46 |
| Placebo | Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | DIE | 5.81 Percentage of changes in the size | Standard Deviation 37.73 |
| Placebo | Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 | Adenomyosis | -6.99 Percentage of changes in the size | Standard Deviation 25.48 |
p-value: 0.7495% CI: [-40.94, 29.1]ANCOVA
Comparison: Endometriomap-value: 0.6595% CI: [-36.8, 22.82]ANCOVA
Comparison: DIEp-value: 0.9295% CI: [-22.77, 20.51]ANCOVA
Secondary
Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4
Assessed by blood sample collection
Time frame: Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Population: Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 1080 µg | Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4 | Within 1-5 days of randomization | 11.66 pg/mL | Standard Deviation 5.23 |
| Quinagolide 1080 µg | Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4 | Within 7-14 days of randomization | 5.50 pg/mL | Standard Deviation 2.59 |
| Quinagolide 1080 µg | Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4 | Cycle 1 | 2.90 pg/mL | Standard Deviation 1.33 |
| Quinagolide 1080 µg | Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4 | Cycle 2 | 2.92 pg/mL | Standard Deviation 1.68 |
| Quinagolide 1080 µg | Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4 | Cycle 3 | 2.78 pg/mL | Standard Deviation 1.32 |
| Quinagolide 1080 µg | Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4 | Cycle 4 | 3.16 pg/mL | Standard Deviation 3.03 |
Secondary
Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinagolide 1080 µg | Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4 | Endometrioma | 18.9 Percentage of lesions |
| Quinagolide 1080 µg | Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4 | DIE | 0 Percentage of lesions |
| Quinagolide 1080 µg | Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4 | Adenomyosis | 12.1 Percentage of lesions |
| Placebo | Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4 | Endometrioma | 21.7 Percentage of lesions |
| Placebo | Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4 | DIE | 12.1 Percentage of lesions |
| Placebo | Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4 | Adenomyosis | 24.1 Percentage of lesions |
Comparison: Endometriomap-value: 0.9595% CI: [0.38, 2.82]Regression, Logistic
Comparison: Adenomyosisp-value: 0.3995% CI: [0.14, 2.17]Regression, Logistic
Secondary
Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinagolide 1080 µg | Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4 | Endometrioma | 24.0 Percentage of subjects |
| Quinagolide 1080 µg | Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4 | DIE | 0 Percentage of subjects |
| Quinagolide 1080 µg | Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4 | Adenomyosis | 15.0 Percentage of subjects |
| Placebo | Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4 | Endometrioma | 31.8 Percentage of subjects |
| Placebo | Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4 | DIE | 11.5 Percentage of subjects |
| Placebo | Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4 | Adenomyosis | 37.5 Percentage of subjects |
Comparison: Endometriomap-value: 0.695% CI: [0.19, 2.65]Regression, Logistic
Comparison: Adenomyosisp-value: 0.2195% CI: [0.07, 1.79]Regression, Logistic
Secondary
Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters
Assessed by blood sample collection
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quinagolide 1080 µg | Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters | 2.86 Percentage of subjects |
| Placebo | Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters | 0 Percentage of subjects |
Secondary
Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4
Assessed by blood sample collection
Time frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 1080 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 2 | 19.9 nmol/L | Standard Deviation 6.511 |
| Quinagolide 1080 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | DIE at cycle 4 | 20.98 nmol/L | Standard Deviation 5.678 |
| Quinagolide 1080 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | DIE at cycle 1 | 22.16 nmol/L | Standard Deviation 8.099 |
| Quinagolide 1080 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 1 | 21.80 nmol/L | Standard Deviation 7.763 |
| Quinagolide 1080 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 4 | 21.82 nmol/L | Standard Deviation 5.45 |
| Quinagolide 1080 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 2 | 19.17 nmol/L | Standard Deviation 6.497 |
| Quinagolide 1080 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | DIE at cycle 2 | 18.01 nmol/L | Standard Deviation 5.484 |
| Quinagolide 1080 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 4 | 21.19 nmol/L | Standard Deviation 6.331 |
| Quinagolide 1080 µg | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 1 | 23.90 nmol/L | Standard Deviation 8.002 |
| Placebo | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 4 | 18.93 nmol/L | Standard Deviation 4.836 |
| Placebo | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 1 | 22.96 nmol/L | Standard Deviation 6.721 |
| Placebo | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 2 | 21.81 nmol/L | Standard Deviation 5.481 |
| Placebo | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 4 | 20.22 nmol/L | Standard Deviation 5.786 |
| Placebo | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | DIE at cycle 1 | 23.68 nmol/L | Standard Deviation 6.135 |
| Placebo | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | DIE at cycle 2 | 21.07 nmol/L | Standard Deviation 6.526 |
| Placebo | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | DIE at cycle 4 | 20.53 nmol/L | Standard Deviation 6.083 |
| Placebo | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 1 | 22.51 nmol/L | Standard Deviation 4.58 |
| Placebo | Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 2 | 19.93 nmol/L | Standard Deviation 5.233 |
Secondary
Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4
Assessed by blood sample collection
Time frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 1080 µg | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 2 | 9.30 pg/L | Standard Deviation 4.739 |
| Quinagolide 1080 µg | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | DIE at cycle 4 | 10.65 pg/L | Standard Deviation 4.465 |
| Quinagolide 1080 µg | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | DIE at cycle 1 | 5.95 pg/L | Standard Deviation 3.258 |
| Quinagolide 1080 µg | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 1 | 5.80 pg/L | Standard Deviation 4.017 |
| Quinagolide 1080 µg | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 4 | 9.47 pg/L | Standard Deviation 4.081 |
| Quinagolide 1080 µg | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 2 | 7.97 pg/L | Standard Deviation 2.608 |
| Quinagolide 1080 µg | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | DIE at cycle 2 | 10.36 pg/L | Standard Deviation 5.118 |
| Quinagolide 1080 µg | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 4 | 9.35 pg/L | Standard Deviation 3.418 |
| Quinagolide 1080 µg | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 1 | 5.51 pg/L | Standard Deviation 3.604 |
| Placebo | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 4 | 11.95 pg/L | Standard Deviation 4.395 |
| Placebo | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 1 | 12.68 pg/L | Standard Deviation 4.618 |
| Placebo | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 2 | 12.79 pg/L | Standard Deviation 4.381 |
| Placebo | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 4 | 12.31 pg/L | Standard Deviation 6.648 |
| Placebo | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | DIE at cycle 1 | 10.80 pg/L | Standard Deviation 4.201 |
| Placebo | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | DIE at cycle 2 | 11.85 pg/L | Standard Deviation 5.029 |
| Placebo | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | DIE at cycle 4 | 12.08 pg/L | Standard Deviation 6.739 |
| Placebo | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 1 | 12.13 pg/L | Standard Deviation 4.563 |
| Placebo | Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 2 | 11.94 pg/L | Standard Deviation 4.15 |
Secondary
Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4
Assessed by blood sample collection
Time frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Population: All analyses for primary and secondary efficacy endpoints are presented by lesion type. This means one subject can be included in multiple lesion groups, depending on the type of lesion(s) with a size of ≥10 mm present at baseline. Thus, the FAS population by lesion type includes 47 subjects in the endometrioma group, 45 subjects in the DIE group, and 36 subjects in the adenomyosis group. The primary and secondary efficacy results are presented for these subjects unless otherwise specified.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinagolide 1080 µg | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 2 | 1.785 mIU/L | Standard Deviation 1.0535 |
| Quinagolide 1080 µg | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | DIE at cycle 4 | 1.375 mIU/L | Standard Deviation 0.8953 |
| Quinagolide 1080 µg | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | DIE at cycle 1 | 1.706 mIU/L | Standard Deviation 1.555 |
| Quinagolide 1080 µg | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 1 | 2.067 mIU/L | Standard Deviation 1.81 |
| Quinagolide 1080 µg | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 4 | 1.692 mIU/L | Standard Deviation 0.9489 |
| Quinagolide 1080 µg | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 2 | 1.722 mIU/L | Standard Deviation 1.1557 |
| Quinagolide 1080 µg | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | DIE at cycle 2 | 1.726 mIU/L | Standard Deviation 1.1633 |
| Quinagolide 1080 µg | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 4 | 1.801 mIU/L | Standard Deviation 0.9463 |
| Quinagolide 1080 µg | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 1 | 1.672 mIU/L | Standard Deviation 1.3376 |
| Placebo | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 4 | 1.353 mIU/L | Standard Deviation 0.5614 |
| Placebo | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 1 | 1.513 mIU/L | Standard Deviation 0.6822 |
| Placebo | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 2 | 1.509 mIU/L | Standard Deviation 0.6746 |
| Placebo | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Endometrioma at cycle 4 | 1.422 mIU/L | Standard Deviation 0.6528 |
| Placebo | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | DIE at cycle 1 | 1.394 mIU/L | Standard Deviation 0.82 |
| Placebo | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | DIE at cycle 2 | 1.383 mIU/L | Standard Deviation 0.6903 |
| Placebo | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | DIE at cycle 4 | 1.299 mIU/L | Standard Deviation 0.6571 |
| Placebo | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 1 | 1.325 mIU/L | Standard Deviation 0.7248 |
| Placebo | Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 | Adenomyosis at cycle 2 | 1.311 mIU/L | Standard Deviation 0.5664 |