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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

June 27, 2012
April 15, 2014
September 2012
April 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01631903 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Uterine Fibroids
  • Drug: telepristone acetate 12 mg
    12 mg, vaginal capsule, once daily for 4 months
    Other Name: Proellex
  • Drug: telepristone acetate 3 mg
    3 mg, vaginal capsule, once daily for 3 months
    Other Name: Proellex
  • Drug: telepristone acetate 6 mg
    6 mg, vaginal capsule, once daily for 3 months
    Other Name: Proellex
  • Drug: telepristone acetate 12 mg
    12 mg, vaginal capsule, once daily, for 3 months
    Other Name: Proellex
  • Drug: telepristone acetate 24 mg
    24 mg, vaginal capsule, once daily for 4 months
    Other Name: Proellex
  • Experimental: Arm 2 (3mg)
    Intervention: Drug: telepristone acetate 3 mg
  • Experimental: Arm 3 (6 mg)
    Intervention: Drug: telepristone acetate 6 mg
  • Experimental: Arm 4 (12 mg)
    Intervention: Drug: telepristone acetate 12 mg
  • Experimental: Arm 5 (24 mg)
    Intervention: Drug: telepristone acetate 24 mg
  • 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
    Intervention: Drug: telepristone acetate 12 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years to 47 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01631903
ZPV-200 EXT
No
Repros Therapeutics Inc.
Repros Therapeutics Inc.
Not Provided
Not Provided
Repros Therapeutics Inc.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP