Extension of Study ZPV-200
This study is enrolling participants by invitation only.
Sponsor:
Repros Therapeutics Inc.
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01631903
First received: June 27, 2012
Last updated: November 13, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Fibroids |
Drug: telepristone acetate 12 mg Drug: telepristone acetate 3 mg Drug: telepristone acetate 6 mg Drug: telepristone acetate 24 mg |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multi-Center, Five-Arm, Parallel Design, Randomized, Single-Blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Confirmed by Ultrasound |
Further study details as provided by Repros Therapeutics Inc.:
Primary Outcome Measures:
- Bleeding Scores [ Time Frame: 3 or 4 months depending on treatment arm ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 48 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 2 (3mg) |
Drug: telepristone acetate 3 mg
3 mg, vaginal capsule, once daily for 3 months
Other Name: Proellex
|
| Experimental: Arm 3 (6 mg) |
Drug: telepristone acetate 6 mg
6 mg, vaginal capsule, once daily for 3 months
Other Name: Proellex
|
| Experimental: Arm 4 (12 mg) |
Drug: telepristone acetate 12 mg
12 mg, vaginal capsule, once daily, for 3 months
Other Name: Proellex
|
| Experimental: Arm 5 (24 mg) |
Drug: telepristone acetate 24 mg
24 mg, vaginal capsule, once daily for 4 months
Other Name: Proellex
|
|
Experimental: PK arm (12 mg)
PK arm requires one additional 24 hour PK assessment at V3 and daily visits between visits 2 and 3 for drug trough sample collection
|
Drug: telepristone acetate 12 mg
12 mg, vaginal capsule, once daily for 4 months
Other Name: Proellex
|
Eligibility| Ages Eligible for Study: | 18 Years to 47 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Repros Therapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT01631903 History of Changes |
| Other Study ID Numbers: | ZPV-200 EXT |
| Study First Received: | June 27, 2012 |
| Last Updated: | November 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 19, 2013