Uterine Fibroids
Conditions
Brief summary
The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.
Interventions
DRUGtelepristone acetate 12 mg
12 mg, vaginal capsule, once daily for 4 months
DRUGtelepristone acetate 3 mg
3 mg, vaginal capsule, once daily for 3 months
DRUGtelepristone acetate 6 mg
6 mg, vaginal capsule, once daily for 3 months
DRUGtelepristone acetate 24 mg
24 mg, vaginal capsule, once daily for 4 months
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 47 Years
Healthy volunteers
No
Inclusion criteria
* Healthy adult females between 18 and 47 years of age with uterine fibroids confirmed by ultrasound. Normal, or abnormal but non-clinically significant, transvaginal ultrasound. History of menstrual events occurring in regular cycles. * Agreement not to attempt to become pregnant. * 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 subject diary and study procedures in compliance with the protocol. * Agrees to use the condoms provided and no other method of birth control (hormonal methods, contraceptive sponge, spermicide or cervical cap) over the course of the study. * Has a negative pregnancy test at the Screening and Baseline visits. An exception for the pregnancy test requirement will be granted for subjects providing verification of surgical sterilization. * A Body Mass Index (BMI) between 18 and 39 inclusive. * Is available for all treatment and follow-up visits. * Subject is able to insert vaginal suppositories. * Subject is willing to exclusively use sanitary napkins (no tampons) during study duration.
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 7 month study period. * Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 1.5x ULN AND total bilirubin exceeding 1.5xULN 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. * Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study. * Use of oral contraceptives in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months. * Has an IUD in place. * Women currently using narcotics. * Women currently taking cimetidine or spironolactone. * Clinically significant abnormal findings on screening examination 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. * Participation in study ZP-204.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding Scores | 3 or 4 months depending on treatment arm | The primary efficacy endpoint will be bleeding assessed using the change in PBAC scores from the 4 weeks prior to Visit 2 to the 4 weeks prior to Visit 10 |
Countries
United States
Outcome results
None listed