Extension of Study ZPV-200

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01631903
First received: June 27, 2012
Last updated: April 15, 2014
Last verified: November 2012
  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
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631903

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:
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: April 15, 2014
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 July 22, 2014