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
1 other identifier
interventional
N/A
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2013
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 7, 2014
February 1, 2014
1 year
October 10, 2013
February 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
12 mg Proellex
EXPERIMENTAL12 mg capsules, orally, once daily for 8 months, including off-drug interval
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Little Rock, Arkansas, 72223, United States
Unknown Facility
Clearwater, Florida, 33759, United States
Unknown Facility
Margate, Florida, 33063, United States
Unknown Facility
Summerville, South Carolina, 29485, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Riverton, Utah, 84065, United States
Unknown Facility
Salt Lake City, Utah, 84124, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2013
First Posted
October 14, 2013
Study Start
December 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 7, 2014
Record last verified: 2014-02