Extension of Study ZPV-200

NCT01631903 | Completed Phase 2

• 1 other identifier: ZPV-200 EXT
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Arm 2 (3mg)

EXPERIMENTAL

Drug: telepristone acetate 3 mg

Arm 3 (6 mg)

EXPERIMENTAL

Drug: telepristone acetate 6 mg

Arm 4 (12 mg)

EXPERIMENTAL

Drug: telepristone acetate 12 mg

Arm 5 (24 mg)

EXPERIMENTAL

Drug: telepristone acetate 24 mg

PK arm (12 mg)

EXPERIMENTAL

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

Interventions

telepristone acetate 12 mg DRUG

12 mg, vaginal capsule, once daily for 4 months

Also known as: Proellex

PK arm (12 mg)

telepristone acetate 3 mg DRUG

3 mg, vaginal capsule, once daily for 3 months

Also known as: Proellex

Arm 2 (3mg)

telepristone acetate 6 mg DRUG

6 mg, vaginal capsule, once daily for 3 months

Also known as: Proellex

Arm 3 (6 mg)

telepristone acetate 24 mg DRUG

24 mg, vaginal capsule, once daily for 4 months

Also known as: Proellex

Arm 5 (24 mg)

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (2)

Unknown Facility

Miami Gardens, Florida, 33169, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Related Links

• Sponsor's corporate web page

MeSH Terms

Conditions

Leiomyoma

Interventions

telapristone acetate

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: June 29, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 16, 2014

Record last verified: 2012-11

Locations

US (2)