Extension of Study ZPV-200

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

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.

Study Overview

• Status: Completed
• Conditions: Uterine Fibroids
• Intervention / Treatment: Drug: telepristone acetate 3 mg; Drug: telepristone acetate 6 mg; Drug: telepristone acetate 12 mg; Drug: telepristone acetate 12 mg; Drug: telepristone acetate 24 mg

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami Gardens, Florida, United States, 33169
  • Texas
    • Houston, Texas, United States, 77030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 2 (3mg)	Drug: telepristone acetate 3 mg; 3 mg, vaginal capsule, once daily for 3 months; Other Names: Proellex
Experimental: Arm 3 (6 mg)	Drug: telepristone acetate 6 mg; 6 mg, vaginal capsule, once daily for 3 months; Other Names: Proellex
Experimental: Arm 4 (12 mg)	Drug: telepristone acetate 12 mg; 12 mg, vaginal capsule, once daily for 4 months; Other Names: Proellex; Drug: telepristone acetate 12 mg; 12 mg, vaginal capsule, once daily, for 3 months; Other Names: Proellex
Experimental: Arm 5 (24 mg)	Drug: telepristone acetate 24 mg; 24 mg, vaginal capsule, once daily for 4 months; Other Names: 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 Names: Proellex; Drug: telepristone acetate 12 mg; 12 mg, vaginal capsule, once daily, for 3 months; Other Names: Proellex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding Scores	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	3 or 4 months depending on treatment arm

Collaborators and Investigators

• Sponsor: Repros Therapeutics Inc.

Publications and helpful links

Helpful Links

• Sponsor's corporate web page

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 27, 2012
• First Submitted That Met QC Criteria: June 28, 2012
• First Posted (Estimate): June 29, 2012

Study Record Updates

• Last Update Posted (Estimate): April 16, 2014
• Last Update Submitted That Met QC Criteria: April 15, 2014
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: ZPV-200 EXT