Extension of Study ZPV-200

Sponsor

Repros Therapeutics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01631903

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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 12 mg Drug: telepristone acetate 24 mg	Phase 2

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2012

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 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 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 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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 47 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1		Miami Gardens	Florida	United States	33169
2		Houston	Texas	United States	77030

Sponsors and Collaborators

Repros Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Sponsor's corporate web page

Publications

None provided.

Responsible Party:

Repros Therapeutics Inc.

ClinicalTrials.gov Identifier:

NCT01631903

Other Study ID Numbers:

ZPV-200 EXT

First Posted:

Jun 29, 2012

Last Update Posted:

Apr 16, 2014

Last Verified:

Nov 1, 2012

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Study Results

No Results Posted as of Apr 16, 2014