Endometriosis
Conditions
Brief summary
The primary purpose of this study is to determine the safety and efficacy of two oral doses of telapristone acetate administered to premenopausal women with pelvic pain associated with endometriosis confirmed within the last seven years and using prescription analgesics for symptomatic pain.
Detailed description
This study is a phase 2, 3-arm-study with an 18-week active dosing period and an option for participants to receive 2 additional 16-week cycles of active treatment at their randomized dose \[6 mg or 12 mg/day\]. Placebo participants who elect additional treatment will receive treatment at 12 mg/day. The treatment dose will remain double-blind. The study will be conducted in 3 stages. The first stage is a no treatment baseline assessment period. This stage will last as long as it takes to record at least one full menstrual cycle (ovulation until ovulation). For stage 2, following the run-in stage, at Visit 3, 60 participants will be randomized into one of 3 arms in a 1-1-1 fashion. The start of dosing should commence as soon as possible after ovulation following the end of the previous menstrual event. For stage 3, participants who are eligible to receive additional cycles of treatment and who elect to continue treatment will be scheduled within a week before the second expected menses (+/- 2 days), following the off-drug interval. Participants will receive 2 cycles of treatment separated by an off-drug interval (ODI), after which they will be followed until menses has returned.
Interventions
DRUGPlacebo
Placebo matching capsules, orally, once daily for 18 weeks.
Telapristone acetate capsules, orally once daily for 18 weeks.
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 47 Years
Healthy volunteers
No
Inclusion criteria
* Adult females between 18 and 47 years of age using prescription analgesics for endometriosis pain and with a Biberoglu Behrman Symptom Severity Scale (BBSS) score ≥7 at screening (assessed over the previous 28 days). * Endometriosis diagnosis must have been surgically confirmed within 7 years. A laparoscopic diagnosis is acceptable. * Participants must have a history of at least 3 regular menstrual cycles in which symptoms of endometriosis occurred immediately prior to screening. * Normal or abnormal but non-clinically significant transvaginal ultrasound. * History of menstrual events occurring in regular cycles. * Agreement not to attempt to become pregnant during the trial. * Agreement to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours before each visit. * Ability to complete a daily electronic participant diary and study procedures in compliance with the protocol. * Women of child-bearing potential must be willing to use double-barrier contraception during the study and for 30 days after discontinuation of study medication. Acceptable double-barrier methods are: male condom with spermicide; male condom with diaphragm; diaphragm containing spermicide plus additional intra-vaginal spermicide. * Has a negative pregnancy test at the Screening and Baseline visits, and subsequent study visits. * A Body Mass Index (BMI) between 18 and 39 inclusive. * Is available for all treatment and follow-up visits.
Exclusion criteria
* Post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy. * Pregnant or lactating or is attempting or expecting to become pregnant during the 6-7 month study period. * Women with abnormally high liver enzymes or liver disease \[alanine transaminase (ALT) or aspartate aminotransferase (AST) exceeding 2 x upper limit of normal (ULN) and total bilirubin exceeding 1.5 x ULN at screening and confirmed on repeat\]. * Received an investigational drug in the 30 days prior to the screening for this study. * History of polycystic ovary syndrome (PCOS). * Concurrent use of any testosterone, androgen, anabolic steroids, dehydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to screening and during the study. Oral contraceptive use for control of endometriosis symptoms is acceptable for the first 28-days of the study. * Use of Depo-Provera® in the preceding 6 months. * Use of Gonadotrophin releasing hormone (GnRH) as (e.g. Lupron Depot) within 3 months of the first dose of study drug (Lupron Depot must have a wash-out period of 3 months after the period of duration of the Lupron dose). * Has an intrauterine device (IUD) in place. Copper IUDs (non-hormone containing will be permitted). * Presence of intramural fibroids that impact the endometrial stripe, submucosal fibroids (any size), or endometrial polyps. Subserosal and intramural fibroids with no impact on the endometrial stripe are acceptable. * Presence of endometrioma(s). * Present history or condition that causes non-endometriosis related dyspareunia (e.g. vulvar vestibulitis). * Past or present history of thrombophlebitis or thromboembolic disorders. * Known or suspected carcinoma of the breast or reproductive organs. * History of abnormal electrocardiogram (ECG) that, in the opinion of the investigator, is clinically significant and will prevent the participant from completing the study, including a QTc (corrected QT interval) of greater than 450 milliseconds (ms). * Cervical dysplasia classified as Atypical Squamous Cells of Undetermined Significance (ASCUS) associated with high-risk human papilloma virus (HPV) or Low/High Grade Squamous Intraepithelial Lesion (LGSIL or HGSIL). * History of abnormal endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN). * Recent history (within past 6 months) of alcoholism or drug abuse. * Known active infection with Human Immunodeficiency Virus (HIV), Hepatitis A, B or C. * Previous history of auto-immune disease and/or positive antinuclear antigen (ANA). * Endometrial stripe ≥18 mm in thickness at Visit 1. * Women currently taking cimetidine or spironolactone. * Clinically significant abnormal findings on screening examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea | Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1) | The BBSS scale defined dysmenorrhea according to the loss of work efficiency and need for bed rest. The dysmenorrhea was graded on a scale from 0 to 3 where, 0 = None; 1 = Mild (some loss in work efficiency); 2 = Moderate (in bed part of the day, occasional loss of work efficiency); 3 = Severe (in bed one or more days, incapacitation), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement. |
| Change From Baseline in Individual BBSS Score for Dyspareunia | Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1) | The BBSS scale defined deep dyspareunia according to the limitation of sexual activity. The dyspareunia was graded on a scale from 0 to 3 where, 0= None (no discomfort); 1= Mild (tolerated discomfort); 2= Moderate (intercourse painful to the point of interruption); 3= Severe (intercourse avoided because of pain), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.. |
| Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain | Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1) | The BBSS scale defined non-menstrual pelvic pain according to various degrees of discomfort and use of analgesics. The non-menstrual pelvic pain was graded on a scale from 0 to 3 where, 0= None (absence of pain); 1= Mild (occasional pelvic discomfort); 2= Moderate (noticeable discomfort for most of the cycle); 3= Severe (pain persisting during the cycle or requiring strong analgesics), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Non-Prescription Analgesics Usage | Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) | An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are OTC analgesics. Participants were provided with a daily diary to record the number of pills of over the counter drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement. |
| Change From Baseline in Total Analgesics Usage | Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) | An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. The daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement. |
| Percentage Change From Baseline in Total Analgesics Usage | Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) | An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28-day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement. |
| Change From Baseline in Prescription Analgesics Usage | Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) | An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement. |
| Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score | Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1) | A 100-millimeter (mm) VAS was used to grade the severity of dysmenorrhea, and non-menstrual pelvic pain. The lowest value indicated the absence of pain and the highest value indicated pain as bad as it could be; a score of 1-50 was considered mild pain, 51-80 moderate pain and 81-100 severe pain. A negative change from Baseline indicates improvement. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain. |
| Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1) | NRS is a valid and reliable clinical measure to assess pain intensity. Sex Avoidance Pain (SAP) and Endometriosis Pain (EP) were assessed using NRS-11 to measure pain based on pain ratings given by participants on the scale of 0 to 10 where, 0 represents no pain and 10 represents the worst pain possible. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement. |
| Change From Baseline in BBSS Physician-Reported Scores | Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1) | BBSS Physician-Reported Scores included two scores: Pelvic Tenderness Score (PTS) and Induration Score (IS). PTS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (minimal tenderness on palpation); 2= Moderate (extensive tenderness on palpation); 3= Severe (unable to palpate because of tenderness). IS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (uterus freely mobile, induration on the cul-de-sac); 2= Moderate (thickened and indurated adnexa and cul-de-sac, restricted uterine mobility); 3= Severe (nodular adnexa and cul-de-sac, uterus frequently frozen), with higher scores indicating more severe symptoms. A negative change from Baseline indicates improvement. Data from On-drug cycle and Off-drug interval (ODI) were reported. |
| Percentage Change From Baseline in Prescription Analgesics Usage | Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) | An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28.The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change from Baseline indicates improvement. |
| Change From Baseline in Non-Prescription Analgesics Usage | Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) | An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are over-the-counter (OTC) analgesics. Participants were provided with a daily diary to record the number of pills of OTC drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3. | 17 |
| Telapristone Acetate 6 mg Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3. | 20 |
| Telapristone Acetate 12 mg Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3. | 23 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Stage 1 and 2 | Lost to Follow-up | 1 | 1 | 0 |
| Stage 1 and 2 | Moved to Active Drug/ Lack of Efficacy | 1 | 0 | 0 |
| Stage 1 and 2 | Non-compliance with Protocol | 0 | 0 | 1 |
| Stage 1 and 2 | Pregnancy | 1 | 0 | 0 |
| Stage 1 and 2 | Withdrew due to Adverse Events/Toxicity | 2 | 3 | 3 |
| Stage 3 | Lost to Follow-up | 0 | 3 | 1 |
| Stage 3 | Non-compliance with Protocol | 0 | 0 | 1 |
| Stage 3 | Pregnancy | 1 | 0 | 0 |
| Stage 3 | Reason Missing | 0 | 0 | 1 |
| Stage 3 | Subject Required Other Treatment | 0 | 1 | 0 |
| Stage 3 | Withdrew Consent | 1 | 0 | 1 |
| Stage 3 | Withdrew due to Adverse Events/Toxicity | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Telapristone Acetate 6 mg | Telapristone Acetate 12 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 28.3 years STANDARD_DEVIATION 6.52 | 30.8 years STANDARD_DEVIATION 5.93 | 30.1 years STANDARD_DEVIATION 7.07 | 29.8 years STANDARD_DEVIATION 6.52 |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 6 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 5 Participants | 4 Participants | 5 Participants | 14 Participants |
| Race/Ethnicity, Customized Non-Hispanic or Non-Latino | 12 Participants | 16 Participants | 18 Participants | 46 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 15 Participants | 14 Participants | 18 Participants | 47 Participants |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 23 Participants | 60 Participants |
| Sex: Female, Male Male | 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 20 | 0 / 23 | 0 / 6 | 0 / 5 | 0 / 11 |
| other Total, other adverse events | 14 / 17 | 17 / 20 | 18 / 23 | 4 / 6 | 5 / 5 | 6 / 11 |
| serious Total, serious adverse events | 0 / 17 | 0 / 20 | 0 / 23 | 0 / 6 | 0 / 5 | 0 / 11 |
Outcome results
Primary
Change From Baseline in Individual BBSS Score for Dyspareunia
The BBSS scale defined deep dyspareunia according to the limitation of sexual activity. The dyspareunia was graded on a scale from 0 to 3 where, 0= None (no discomfort); 1= Mild (tolerated discomfort); 2= Moderate (intercourse painful to the point of interruption); 3= Severe (intercourse avoided because of pain), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement..
Time frame: Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
Population: ITT population included all participants who were randomized and received study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Individual BBSS Score for Dyspareunia | Change from Baseline to Off-Drug Cycle 1 | -21.50 score on a scale per 28-day period | Standard Deviation 18.8 |
| Placebo | Change From Baseline in Individual BBSS Score for Dyspareunia | Baseline | 41.2 score on a scale per 28-day period | Standard Deviation 24.15 |
| Placebo | Change From Baseline in Individual BBSS Score for Dyspareunia | Change from Baseline to On-Drug Cycle 1 | -21.50 score on a scale per 28-day period | Standard Deviation 18.8 |
| Telapristone Acetate 6 mg | Change From Baseline in Individual BBSS Score for Dyspareunia | Change from Baseline to Off-Drug Cycle 1 | -14.75 score on a scale per 28-day period | Standard Deviation 19.749 |
| Telapristone Acetate 6 mg | Change From Baseline in Individual BBSS Score for Dyspareunia | Baseline | 36.5 score on a scale per 28-day period | Standard Deviation 24.43 |
| Telapristone Acetate 6 mg | Change From Baseline in Individual BBSS Score for Dyspareunia | Change from Baseline to On-Drug Cycle 1 | -14.75 score on a scale per 28-day period | Standard Deviation 19.749 |
| Telapristone Acetate 12 mg | Change From Baseline in Individual BBSS Score for Dyspareunia | Change from Baseline to Off-Drug Cycle 1 | -9.83 score on a scale per 28-day period | Standard Deviation 15.594 |
| Telapristone Acetate 12 mg | Change From Baseline in Individual BBSS Score for Dyspareunia | Baseline | 39.8 score on a scale per 28-day period | Standard Deviation 21.42 |
| Telapristone Acetate 12 mg | Change From Baseline in Individual BBSS Score for Dyspareunia | Change from Baseline to On-Drug Cycle 1 | -9.83 score on a scale per 28-day period | Standard Deviation 15.594 |
Comparison: On-Drug Cycle 1p-value: 0.1017Wilcoxon Rank- Sum Test
Comparison: On-Drug Cycle 1p-value: 0.1927Wilcoxon Rank- Sum Test
Comparison: Off-Drug Cycle 1p-value: 0.1017Wilcoxon Rank- Sum Test
Comparison: Off-Drug Cycle 1p-value: 0.1927Wilcoxon Rank- Sum Test
Primary
Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain
The BBSS scale defined non-menstrual pelvic pain according to various degrees of discomfort and use of analgesics. The non-menstrual pelvic pain was graded on a scale from 0 to 3 where, 0= None (absence of pain); 1= Mild (occasional pelvic discomfort); 2= Moderate (noticeable discomfort for most of the cycle); 3= Severe (pain persisting during the cycle or requiring strong analgesics), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.
Time frame: Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
Population: ITT population included all participants who were randomized and received study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain | Change from Baseline to On-Drug Cycle 1 | -6.06 score on a scale per 28-day period | Standard Deviation 11.132 |
| Placebo | Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain | Baseline | 34.3 score on a scale per 28-day period | Standard Deviation 18.07 |
| Placebo | Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain | Change from Baseline to Off-Drug Cycle 1 | -6.87 score on a scale per 28-day period | Standard Deviation 12.034 |
| Telapristone Acetate 6 mg | Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain | Change from Baseline to On-Drug Cycle 1 | -10.01 score on a scale per 28-day period | Standard Deviation 15.2 |
| Telapristone Acetate 6 mg | Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain | Baseline | 33.5 score on a scale per 28-day period | Standard Deviation 17.85 |
| Telapristone Acetate 6 mg | Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain | Change from Baseline to Off-Drug Cycle 1 | -13.09 score on a scale per 28-day period | Standard Deviation 17.745 |
| Telapristone Acetate 12 mg | Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain | Baseline | 32.7 score on a scale per 28-day period | Standard Deviation 16.68 |
| Telapristone Acetate 12 mg | Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain | Change from Baseline to Off-Drug Cycle 1 | -8.26 score on a scale per 28-day period | Standard Deviation 13.608 |
| Telapristone Acetate 12 mg | Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain | Change from Baseline to On-Drug Cycle 1 | -2.96 score on a scale per 28-day period | Standard Deviation 15.782 |
Comparison: On-Drug Cycle 1p-value: 0.7508Wilcoxon Rank- Sum Test
Comparison: On-Drug Cycle 1p-value: 0.5507Wilcoxon Rank- Sum Test
Comparison: Off-Drug Cycle 1p-value: 0.3993Wilcoxon Rank- Sum Test
Comparison: Off-Drug Cycle 1p-value: 0.5821Wilcoxon Rank- Sum Test
Primary
Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea
The BBSS scale defined dysmenorrhea according to the loss of work efficiency and need for bed rest. The dysmenorrhea was graded on a scale from 0 to 3 where, 0 = None; 1 = Mild (some loss in work efficiency); 2 = Moderate (in bed part of the day, occasional loss of work efficiency); 3 = Severe (in bed one or more days, incapacitation), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.
Time frame: Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
Population: Intent-to-Treat (ITT) population included all participants who were randomized and received study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea | Change from Baseline to On-Drug Cycle 1 | -3.95 score on a scale per 28-day period | Standard Deviation 5.936 |
| Placebo | Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea | Baseline | 12.6 score on a scale per 28-day period | Standard Deviation 5.58 |
| Placebo | Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea | Change from Baseline to Off-Drug Cycle 1 | -2.43 score on a scale per 28-day period | Standard Deviation 7.852 |
| Telapristone Acetate 6 mg | Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea | Change from Baseline to On-Drug Cycle 1 | -8.46 score on a scale per 28-day period | Standard Deviation 5.174 |
| Telapristone Acetate 6 mg | Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea | Baseline | 10.8 score on a scale per 28-day period | Standard Deviation 6.9 |
| Telapristone Acetate 6 mg | Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea | Change from Baseline to Off-Drug Cycle 1 | 1.36 score on a scale per 28-day period | Standard Deviation 14.546 |
| Telapristone Acetate 12 mg | Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea | Baseline | 11.1 score on a scale per 28-day period | Standard Deviation 5.55 |
| Telapristone Acetate 12 mg | Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea | Change from Baseline to Off-Drug Cycle 1 | -1.82 score on a scale per 28-day period | Standard Deviation 9.054 |
| Telapristone Acetate 12 mg | Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea | Change from Baseline to On-Drug Cycle 1 | -6.46 score on a scale per 28-day period | Standard Deviation 10.668 |
Comparison: On-Drug Cycle 1p-value: 0.036Wilcoxon Rank- Sum Test
Comparison: On-Drug Cycle 1p-value: 0.1087Wilcoxon Rank- Sum Test
Comparison: Off-Drug Cycle 1p-value: 0.2263Wilcoxon Rank- Sum Test
Comparison: Off-Drug Cycle 1p-value: 0.5375Wilcoxon Rank- Sum Test
Secondary
Change From Baseline in BBSS Physician-Reported Scores
BBSS Physician-Reported Scores included two scores: Pelvic Tenderness Score (PTS) and Induration Score (IS). PTS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (minimal tenderness on palpation); 2= Moderate (extensive tenderness on palpation); 3= Severe (unable to palpate because of tenderness). IS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (uterus freely mobile, induration on the cul-de-sac); 2= Moderate (thickened and indurated adnexa and cul-de-sac, restricted uterine mobility); 3= Severe (nodular adnexa and cul-de-sac, uterus frequently frozen), with higher scores indicating more severe symptoms. A negative change from Baseline indicates improvement. Data from On-drug cycle and Off-drug interval (ODI) were reported.
Time frame: Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
Population: ITT population included all participants who were randomized and received study drug. Last observation carried forward (LOCF) approach was used to impute missing data in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in BBSS Physician-Reported Scores | PTS at Baseline (BL) | 1.9 score on a scale | Standard Deviation 0.83 |
| Placebo | Change From Baseline in BBSS Physician-Reported Scores | PTS Change from BL to LOCF Cycle 1 | -0.76 score on a scale | Standard Deviation 0.903 |
| Placebo | Change From Baseline in BBSS Physician-Reported Scores | PTS Change from BL to ODI Cycle 1 | -0.92 score on a scale | Standard Deviation 0.954 |
| Placebo | Change From Baseline in BBSS Physician-Reported Scores | IS at Baseline | 1.0 score on a scale | Standard Deviation 1.06 |
| Placebo | Change From Baseline in BBSS Physician-Reported Scores | IS Change from BL to LOCF Cycle 1 | -0.53 score on a scale | Standard Deviation 1.007 |
| Placebo | Change From Baseline in BBSS Physician-Reported Scores | IS Change from BL to ODI Cycle 1 | -0.54 score on a scale | Standard Deviation 0.967 |
| Telapristone Acetate 6 mg | Change From Baseline in BBSS Physician-Reported Scores | IS Change from BL to ODI Cycle 1 | -0.59 score on a scale | Standard Deviation 0.87 |
| Telapristone Acetate 6 mg | Change From Baseline in BBSS Physician-Reported Scores | PTS at Baseline (BL) | 1.8 score on a scale | Standard Deviation 0.77 |
| Telapristone Acetate 6 mg | Change From Baseline in BBSS Physician-Reported Scores | IS at Baseline | 1.1 score on a scale | Standard Deviation 1.05 |
| Telapristone Acetate 6 mg | Change From Baseline in BBSS Physician-Reported Scores | IS Change from BL to LOCF Cycle 1 | -0.70 score on a scale | Standard Deviation 0.923 |
| Telapristone Acetate 6 mg | Change From Baseline in BBSS Physician-Reported Scores | PTS Change from BL to LOCF Cycle 1 | -0.95 score on a scale | Standard Deviation 1.146 |
| Telapristone Acetate 6 mg | Change From Baseline in BBSS Physician-Reported Scores | PTS Change from BL to ODI Cycle 1 | -0.59 score on a scale | Standard Deviation 0.712 |
| Telapristone Acetate 12 mg | Change From Baseline in BBSS Physician-Reported Scores | PTS Change from BL to LOCF Cycle 1 | -0.43 score on a scale | Standard Deviation 0.843 |
| Telapristone Acetate 12 mg | Change From Baseline in BBSS Physician-Reported Scores | PTS Change from BL to ODI Cycle 1 | -0.18 score on a scale | Standard Deviation 1.006 |
| Telapristone Acetate 12 mg | Change From Baseline in BBSS Physician-Reported Scores | IS Change from BL to ODI Cycle 1 | -0.41 score on a scale | Standard Deviation 0.796 |
| Telapristone Acetate 12 mg | Change From Baseline in BBSS Physician-Reported Scores | IS at Baseline | 0.8 score on a scale | Standard Deviation 0.83 |
| Telapristone Acetate 12 mg | Change From Baseline in BBSS Physician-Reported Scores | PTS at Baseline (BL) | 1.5 score on a scale | Standard Deviation 0.67 |
| Telapristone Acetate 12 mg | Change From Baseline in BBSS Physician-Reported Scores | IS Change from BL to LOCF Cycle 1 | -0.39 score on a scale | Standard Deviation 0.988 |
Comparison: PTS: LOCF Cycle 1p-value: 0.4365Wilcoxon Rank- Sum Test
Comparison: PTS: LOCF Cycle 1p-value: 0.1302Wilcoxon Rank- Sum Test
Comparison: PTS: ODI Cycle 1p-value: 0.3591Wilcoxon Rank- Sum Test
Comparison: PTS: ODI Cycle 1p-value: 0.0872Wilcoxon Rank- Sum Test
Comparison: IS: LOCF Cycle 1p-value: 0.4814Wilcoxon Rank- Sum Test
Comparison: IS: LOCF Cycle 1p-value: 0.9162Wilcoxon Rank- Sum Test
Comparison: IS: ODI Cycle 1p-value: 0.6607Wilcoxon Rank- Sum Test
Comparison: IS: ODI Cycle 1p-value: 0.9527Wilcoxon Rank- Sum Test
Secondary
Change From Baseline in Non-Prescription Analgesics Usage
An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are over-the-counter (OTC) analgesics. Participants were provided with a daily diary to record the number of pills of OTC drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.
Time frame: Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)
Population: ITT population included all participants who were randomized and received study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Non-Prescription Analgesics Usage | Baseline | 19.0 pills per 28-day period | Standard Deviation 29.05 |
| Placebo | Change From Baseline in Non-Prescription Analgesics Usage | Change from Baseline to On-Drug Cycle | 1.78 pills per 28-day period | Standard Deviation 21.426 |
| Telapristone Acetate 6 mg | Change From Baseline in Non-Prescription Analgesics Usage | Baseline | 15.4 pills per 28-day period | Standard Deviation 26.95 |
| Telapristone Acetate 6 mg | Change From Baseline in Non-Prescription Analgesics Usage | Change from Baseline to On-Drug Cycle | -12.79 pills per 28-day period | Standard Deviation 25.628 |
| Telapristone Acetate 12 mg | Change From Baseline in Non-Prescription Analgesics Usage | Baseline | 43.2 pills per 28-day period | Standard Deviation 98.6 |
| Telapristone Acetate 12 mg | Change From Baseline in Non-Prescription Analgesics Usage | Change from Baseline to On-Drug Cycle | -6.81 pills per 28-day period | Standard Deviation 25.615 |
Comparison: On-Drug Cyclep-value: 0.114Wilcoxon Rank- Sum Test
Comparison: On-Drug Cyclep-value: 0.1636Wilcoxon Rank- Sum Test
Secondary
Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS)
NRS is a valid and reliable clinical measure to assess pain intensity. Sex Avoidance Pain (SAP) and Endometriosis Pain (EP) were assessed using NRS-11 to measure pain based on pain ratings given by participants on the scale of 0 to 10 where, 0 represents no pain and 10 represents the worst pain possible. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.
Time frame: Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
Population: ITT population included all participants who were randomized and received study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | SAP Baseline | 67.9 score on a scale per 28-day period | Standard Deviation 13.26 |
| Placebo | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | SAP Change from BL to On-Drug Cycle 1 | -2.52 score on a scale per 28-day period | Standard Deviation 4.527 |
| Placebo | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | SAP Change from BL to Off-Drug Cycle 1 | -2.21 score on a scale per 28-day period | Standard Deviation 10.125 |
| Placebo | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | EP Baseline | 136.9 score on a scale per 28-day period | Standard Deviation 72.48 |
| Placebo | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | EP Change from BL to On-Drug Cycle 1 | -42.84 score on a scale per 28-day period | Standard Deviation 39.777 |
| Placebo | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | EP Change from BL to Off-Drug Cycle 1 | -44.91 score on a scale per 28-day period | Standard Deviation 43.163 |
| Telapristone Acetate 6 mg | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | EP Change from BL to Off-Drug Cycle 1 | -27.06 score on a scale per 28-day period | Standard Deviation 46.525 |
| Telapristone Acetate 6 mg | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | SAP Baseline | 64.7 score on a scale per 28-day period | Standard Deviation 15.29 |
| Telapristone Acetate 6 mg | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | EP Baseline | 136.2 score on a scale per 28-day period | Standard Deviation 70.6 |
| Telapristone Acetate 6 mg | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | EP Change from BL to On-Drug Cycle 1 | -52.05 score on a scale per 28-day period | Standard Deviation 39.14 |
| Telapristone Acetate 6 mg | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | SAP Change from BL to On-Drug Cycle 1 | -9.43 score on a scale per 28-day period | Standard Deviation 14.48 |
| Telapristone Acetate 6 mg | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | SAP Change from BL to Off-Drug Cycle 1 | -5.88 score on a scale per 28-day period | Standard Deviation 27.822 |
| Telapristone Acetate 12 mg | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | SAP Change from BL to On-Drug Cycle 1 | -0.53 score on a scale per 28-day period | Standard Deviation 10.544 |
| Telapristone Acetate 12 mg | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | SAP Change from BL to Off-Drug Cycle 1 | 3.04 score on a scale per 28-day period | Standard Deviation 14.071 |
| Telapristone Acetate 12 mg | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | EP Change from BL to Off-Drug Cycle 1 | -29.02 score on a scale per 28-day period | Standard Deviation 45.496 |
| Telapristone Acetate 12 mg | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | EP Baseline | 142.4 score on a scale per 28-day period | Standard Deviation 70.92 |
| Telapristone Acetate 12 mg | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | SAP Baseline | 60.6 score on a scale per 28-day period | Standard Deviation 13.86 |
| Telapristone Acetate 12 mg | Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) | EP Change from BL to On-Drug Cycle 1 | -25.98 score on a scale per 28-day period | Standard Deviation 40.954 |
Comparison: SAP: On-Drug Cycle 1p-value: 0.6131Wilcoxon Rank- Sum Test
Comparison: SAP: On-Drug Cycle 1p-value: 0.7881Wilcoxon Rank- Sum Test
Comparison: SAP: Off-Drug Cycle 1p-value: 0.9376Wilcoxon Rank- Sum Test
Comparison: SAP: Off-Drug Cycle 1p-value: 0.6552Wilcoxon Rank- Sum Test
Comparison: EP: On-Drug Cycle 1p-value: 0.7143Wilcoxon Rank- Sum Test
Comparison: EP: On-Drug Cycle 1p-value: 0.2985Wilcoxon Rank- Sum Test
Comparison: EP: Off-Drug Cycle 1p-value: 0.3162Wilcoxon Rank- Sum Test
Comparison: EP: Off-Drug Cycle 1p-value: 0.7503Wilcoxon Rank- Sum Test
Secondary
Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score
A 100-millimeter (mm) VAS was used to grade the severity of dysmenorrhea, and non-menstrual pelvic pain. The lowest value indicated the absence of pain and the highest value indicated pain as bad as it could be; a score of 1-50 was considered mild pain, 51-80 moderate pain and 81-100 severe pain. A negative change from Baseline indicates improvement. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain.
Time frame: Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
Population: ITT population included all participants who were randomized and received study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score | Percentage change from BL to LOCF Cycle 1 | -30.11 score on a scale | Standard Deviation 39.877 |
| Placebo | Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score | Baseline | 57.0 score on a scale | Standard Deviation 27.68 |
| Placebo | Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score | Percent change from BL to ODI Cycle 1 | -29.36 score on a scale | Standard Deviation 46.552 |
| Telapristone Acetate 6 mg | Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score | Percentage change from BL to LOCF Cycle 1 | -46.10 score on a scale | Standard Deviation 46.871 |
| Telapristone Acetate 6 mg | Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score | Baseline | 66.6 score on a scale | Standard Deviation 25.06 |
| Telapristone Acetate 6 mg | Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score | Percent change from BL to ODI Cycle 1 | -12.57 score on a scale | Standard Deviation 52.07 |
| Telapristone Acetate 12 mg | Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score | Baseline | 63.8 score on a scale | Standard Deviation 29.14 |
| Telapristone Acetate 12 mg | Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score | Percent change from BL to ODI Cycle 1 | 118.34 score on a scale | Standard Deviation 596.879 |
| Telapristone Acetate 12 mg | Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score | Percentage change from BL to LOCF Cycle 1 | -17.02 score on a scale | Standard Deviation 88.394 |
Comparison: LOCF Cycle 1p-value: 0.2812Wilcoxon Rank- Sum Test
Comparison: LOCF Cycle 1p-value: 0.5858Wilcoxon Rank- Sum Test
Comparison: ODI Cycle 1p-value: 0.4116Wilcoxon Rank- Sum Test
Comparison: ODI Cycle 1p-value: 0.4252Wilcoxon Rank- Sum Test
Secondary
Change From Baseline in Prescription Analgesics Usage
An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.
Time frame: Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)
Population: ITT population included all participants who were randomized and received study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Prescription Analgesics Usage | Baseline | 14.8 pills per 28-day period | Standard Deviation 18.13 |
| Placebo | Change From Baseline in Prescription Analgesics Usage | Change from Baseline to On-Drug Cycle | -6.74 pills per 28-day period | Standard Deviation 14.897 |
| Telapristone Acetate 6 mg | Change From Baseline in Prescription Analgesics Usage | Baseline | 14.9 pills per 28-day period | Standard Deviation 20.72 |
| Telapristone Acetate 6 mg | Change From Baseline in Prescription Analgesics Usage | Change from Baseline to On-Drug Cycle | -7.20 pills per 28-day period | Standard Deviation 15.948 |
| Telapristone Acetate 12 mg | Change From Baseline in Prescription Analgesics Usage | Baseline | 31.4 pills per 28-day period | Standard Deviation 52.55 |
| Telapristone Acetate 12 mg | Change From Baseline in Prescription Analgesics Usage | Change from Baseline to On-Drug Cycle | -5.87 pills per 28-day period | Standard Deviation 27.753 |
Comparison: On-Drug Cyclep-value: 0.7507Wilcoxon Rank- Sum Test
Comparison: On-Drug Cyclep-value: 0.8919Wilcoxon Rank- Sum Test
Secondary
Change From Baseline in Total Analgesics Usage
An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. The daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.
Time frame: Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)
Population: ITT Population consisted of all participants who were randomized and received study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total Analgesics Usage | Baseline | 33.8 pills per 28-day period | Standard Deviation 32.46 |
| Placebo | Change From Baseline in Total Analgesics Usage | Change from Baseline to On-Drug Cycle | -4.96 pills per 28-day period | Standard Deviation 12.525 |
| Telapristone Acetate 6 mg | Change From Baseline in Total Analgesics Usage | Baseline | 30.2 pills per 28-day period | Standard Deviation 35.09 |
| Telapristone Acetate 6 mg | Change From Baseline in Total Analgesics Usage | Change from Baseline to On-Drug Cycle | -19.99 pills per 28-day period | Standard Deviation 25.132 |
| Telapristone Acetate 12 mg | Change From Baseline in Total Analgesics Usage | Baseline | 74.6 pills per 28-day period | Standard Deviation 126.2 |
| Telapristone Acetate 12 mg | Change From Baseline in Total Analgesics Usage | Change from Baseline to On-Drug Cycle | -12.67 pills per 28-day period | Standard Deviation 38.865 |
Comparison: On-Drug Cyclep-value: 0.1253Wilcoxon Rank- Sum Test
Comparison: On-Drug Cyclep-value: 0.3442Wilcoxon Rank- Sum Test
Secondary
Percentage Change From Baseline in Non-Prescription Analgesics Usage
An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are OTC analgesics. Participants were provided with a daily diary to record the number of pills of over the counter drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.
Time frame: Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)
Population: ITT population included all participants who were randomized and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage Change From Baseline in Non-Prescription Analgesics Usage | 6.06 percent change | Standard Deviation 62.237 |
| Telapristone Acetate 6 mg | Percentage Change From Baseline in Non-Prescription Analgesics Usage | -22.80 percent change | Standard Deviation 57.498 |
| Telapristone Acetate 12 mg | Percentage Change From Baseline in Non-Prescription Analgesics Usage | -31.49 percent change | Standard Deviation 60.114 |
Comparison: On-Drug Cyclep-value: 0.114Wilcoxon Rank- Sum Test
Comparison: On-Drug Cyclep-value: 0.0733Wilcoxon Rank- Sum Test
Secondary
Percentage Change From Baseline in Prescription Analgesics Usage
An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28.The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change from Baseline indicates improvement.
Time frame: Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)
Population: ITT population included all participants who were randomized and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage Change From Baseline in Prescription Analgesics Usage | -9.69 percent change | Standard Deviation 71.98 |
| Telapristone Acetate 6 mg | Percentage Change From Baseline in Prescription Analgesics Usage | -21.63 percent change | Standard Deviation 76.53 |
| Telapristone Acetate 12 mg | Percentage Change From Baseline in Prescription Analgesics Usage | -6.36 percent change | Standard Deviation 174.21 |
Comparison: On-Drug Cyclep-value: 0.478Wilcoxon Rank- Sum Test
Comparison: On-Drug Cyclep-value: 0.2354Wilcoxon Rank- Sum Test
Secondary
Percentage Change From Baseline in Total Analgesics Usage
An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28-day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.
Time frame: Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)
Population: ITT population included all participants who were randomized and received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage Change From Baseline in Total Analgesics Usage | -13.88 percent change | Standard Deviation 64.098 |
| Telapristone Acetate 6 mg | Percentage Change From Baseline in Total Analgesics Usage | -51.96 percent change | Standard Deviation 45.461 |
| Telapristone Acetate 12 mg | Percentage Change From Baseline in Total Analgesics Usage | -36.05 percent change | Standard Deviation 57.129 |
Comparison: On-Drug Cyclep-value: 0.0303Wilcoxon Rank- Sum Test
Comparison: On-Drug Cyclep-value: 0.2864Wilcoxon Rank- Sum Test