Extension of Study ZPV-200

• ClinicalTrials.gov Identifier: NCT01631903
• Recruitment Status: Completed
• First Posted: June 29, 2012
• Last Update Posted: April 16, 2014
• Sponsor: Repros Therapeutics Inc.
• Information provided by (Responsible Party): Repros Therapeutics Inc.

Study Description

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.

Condition or disease	Intervention/treatment	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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• 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
• Study Start Date: September 2012
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: April 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Bleeding Scores [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 47 Years (Adult)
• Sexes 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

Locations

United States, Florida

Miami Gardens, Florida, United States, 33169

United States, Texas

Houston, Texas, United States, 77030

Sponsors and Collaborators

Repros Therapeutics Inc.

More Information

Additional Information:

Sponsor's corporate web page 

• Responsible Party: Repros Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT01631903
• Other Study ID Numbers: ZPV-200 EXT
• First Posted: June 29, 2012
• Last Update Posted: April 16, 2014
• Last Verified: November 2012

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