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Open-Label Extension Study to ZPE-202

Sponsor
Repros Therapeutics Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01961908
Collaborator
(none)
0
Enrollment
7
Locations
1
Arm
12
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a phase 2, open-label extension study of 12 mg Proellex for 2 treatment cycles, each with a 16 week active dosing period. Endometriosis pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia (BBSS) as well as use of pain medications, and vaginal bleeding intensity will be recorded using an electronic diary and Visual Analog Scale (VAS) pain assessment will be utilized. All subjects will have completed an Off-Drug Interval (ODI) prior to starting treatment. Visit 1 will be scheduled within a week before the next expected menses (+/- 2 days), following the off-drug interval. Subjects will receive 2 cycles of treatment separated by an off-drug interval (ODI), after which they will be followed until menses has returned. During the follow-up period subjects will continue to record study information in the electronic diary. The final follow-up visit will be scheduled after blood flow has stopped.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multi-Center, Open-Label Extension Study to Evaluate the Safety and Efficacy of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Endometriosis
Study Start Date :
Dec 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: 12 mg Proellex

12 mg capsules, orally, once daily for 8 months, including off-drug interval

Drug: Proellex
Other Names:
  • telepristone acetate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Prescription Analgesic Use [10 months]

      Percent change from baseline in use of prescription analgesics comparing the ZPE-202 baseline nominal 28-day menstrual cycle (including menstrual event) to a similar period leading up to the end of treatment in the extension study (Visit 10)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 47 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Successful completion of protocol ZPE-202, or subject who withdrew from ZPE-202 for lack of efficacy after completion of at least 28 days of double-blind treatment (after Visit 3)

    • Agreement not to attempt to become pregnant during the trial

    • Women of child-bearing potential must be willing to use double-barrier contraception during the study and for 30 days after discontinuation of study medication. Acceptable double-barrier methods are: male condom with spermicide; male condom with diaphragm; diaphragm containing spermicide plus additional intra-vaginal spermicide

    • Has a negative pregnancy test at Visit 1

    • Is available for all treatment and follow-up visits

    Exclusion Criteria:

    • Subject is pregnant or lactating or is attempting or expecting to become pregnant during the 6-7 month study period

    • Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, dehydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to Visit

    • Presence of intramural fibroids that impact the endometrial stripe, submucosal fibroids (any size), or endometrial polyps. Subserosal and intramural fibroids with no impact on the endometrial stripe are acceptable.

    • Presence of endometrioma(s)

    • Present history or condition that causes non-endometriosis related dyspareunia (e.g. vulvar vestibulitis).

    • Past or present history of thrombophlebitis or thromboembolic disorders.

    • Known or suspected carcinoma of the breast or reproductive organs.

    • Cervical dysplasia classified as Atypical Squamous Cells of Undetermined Significance (ASCUS) associated with high-risk human papilloma virus (HPV) or Low/High Grade Squamous Intraepithelial Lesion (LGSIL or HGSIL).

    • Known active infection with HIV, Hepatitis A, B or C.

    • Endometrial stripe ≥18 mm in thickness at Visit 1.

    • Subject is currently taking cimetidine or spironolactone.

    • Clinically significant abnormal findings on screening examination and laboratory assessments 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Little Rock Arkansas United States 72223
    2 Clearwater Florida United States 33759
    3 Margate Florida United States 33063
    4 Summerville South Carolina United States 29485
    5 Houston Texas United States 77030
    6 Riverton Utah United States 84065
    7 Salt Lake City Utah United States 84124

    Sponsors and Collaborators

    • Repros Therapeutics Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Repros Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT01961908
    Other Study ID Numbers:
    • ZPE-202EXT
    First Posted:
    Oct 14, 2013
    Last Update Posted:
    Feb 7, 2014
    Last Verified:
    Feb 1, 2014
    Additional relevant MeSH terms:
    Endometriosis

    Study Results

    No Results Posted as of Feb 7, 2014