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Open-Label Extension Study to ZPE-202

Primary Purpose

Endometriosis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Proellex
Sponsored by
Repros Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 47 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

12 mg Proellex

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 10, 2013
Last Updated
February 6, 2014
Sponsor
Repros Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01961908
Brief Title
Open-Label Extension Study to ZPE-202
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Repros Therapeutics Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12 mg Proellex
Arm Type
Experimental
Arm Description
12 mg capsules, orally, once daily for 8 months, including off-drug interval
Intervention Type
Drug
Intervention Name(s)
Proellex
Other Intervention Name(s)
telepristone acetate
Primary Outcome Measure Information:
Title
Prescription Analgesic Use
Description
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)
Time Frame
10 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72223
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.reprosrx.com
Description
Sponsor Corporate Website

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Open-Label Extension Study to ZPE-202

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