Overview

This trial is active, not recruiting.

Condition endometriosis
Treatments placebo, proellex 6 mg, proellex 12 mg
Phase phase 2
Sponsor Repros Therapeutics Inc.
Start date November 2012
End date July 2016
Trial size 60 participants
Trial identifier NCT01728454, ZPE-202

Summary

The primary objective of this study is to determine the safety and efficacy of two oral doses of Proellex administered to premenopausal women with pelvic pain associated with endometriosis confirmed within the last seven years and using prescription analgesics for symptomatic pain.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Parallel placebo arm oral, capsules, once a day for 18 weeks
placebo
proellex 6 mg telepristone acetate
proellex 12 mg telepristone acetate
(Experimental)
proellex 6 mg, oral, capsules, once a day for 18 weeks
proellex 6 mg telepristone acetate
(Experimental)
proellex 12 mg, oral, capsules, once a day for 18 weeks
proellex 12 mg telepristone acetate

Primary Outcomes

Measure
Change in individual BBSS pain scores
time frame: 18 weeks

Secondary Outcomes

Measure
Change in use of prescription analgesics
time frame: 18 weeks
Change in use of over the counter analgesics
time frame: 18 weeks
Change in use of overall analgesics
time frame: 18 weeks
Change in physician reported BBSS scores
time frame: 18 weeks
Change in pain assessed using Visual Analog Scale
time frame: 18 weeks
Change in dysmenorrhea and non-menstrual pelvic pain
time frame: 18 weeks

Eligibility Criteria

Female participants from 18 years up to 47 years old.

Inclusion Criteria: - Healthy adult females between 18 and 47 years of age using prescription analgesics for endometriosis pain and with a BBSS score ≥7 at screening (assessed over the previous 28 days, see Appendix 2). - Endometriosis diagnosis must have been surgically confirmed within 7 years. A laparoscopic diagnosis is acceptable. - Subjects 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 subject 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: - Subject is a 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. - Subject is 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. (ALT (alanine transaminase) or AST(aspartate aminotransferase ) exceeding 2 x ULN (upper limit of normal) AND total bilirubin exceeding 1.5x ULN at screening and confirmed on repeat). - Received an investigational drug in the 30 days prior to the screening for this study - Women with a history of PCOS(polycystic ovary syndrome) - Concurrent use of any testosterone, androgen, anabolic steroids, DHEA(dehydroepiandrosterone) 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 GnRHas (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 IUD(intrauterine device) 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 ECG that, in the opinion of the investigator, is clinically significant and will prevent the subject from completing the study, including a QTc(corrected QT interval) of greater than 450 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 EIN(Endometrial Intraepithelial Neoplasia) . - Recent history (within past 6 months) of alcoholism or drug abuse. - Known active infection with 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.

Additional Information

Official title A Phase 2, Multi-Center, Three-Arm, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Endometriosis
Description This study is a phase 2, 3-arm-study with an 18 week active dosing period and an option for subjects to receive 2 additional 16-week cycles of active treatment at their randomized dose (6 mg or 12 mg/day). Placebo subjects 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. In the first stage, women will receive a daily single-blind placebo. 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 subjects 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, subjects 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. Subjects will receive 2 cycles of treatment separated by an off-drug interval (ODI), after which they will be followed until menses has returned.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Repros Therapeutics Inc..