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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01961908
Other study ID # ZPE-202EXT
Secondary ID
Status Withdrawn
Phase Phase 2
First received October 10, 2013
Last updated February 6, 2014
Start date December 2013
Est. completion date December 2014

Study information

Verified date February 2014
Source Repros Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 47 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Proellex


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
See also
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Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
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Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
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Recruiting NCT02481739 - Laparoscopic Surgical Management of Endometriosis on Fertility N/A
Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
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