Open-Label Extension Study to ZPE-202

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Proellex

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72223
  • Florida
    • Clearwater, Florida, United States, 33759
    • Margate, Florida, United States, 33063
  • South Carolina
    • Summerville, South Carolina, United States, 29485
  • Texas
    • Houston, Texas, United States, 77030
  • Utah
    • Riverton, Utah, United States, 84065
    • Salt Lake City, Utah, United States, 84124

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 47 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 1.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prescription Analgesic Use	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)	10 months

Collaborators and Investigators

• Sponsor: Repros Therapeutics Inc.

Publications and helpful links

Helpful Links

• Sponsor Corporate Website

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: October 10, 2013
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (Estimate): October 14, 2013

Study Record Updates

• Last Update Posted (Estimate): February 7, 2014
• Last Update Submitted That Met QC Criteria: February 6, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: ZPE-202EXT