Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00958412
Other study ID # ZPE-201 EXT
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date February 28, 2009
Est. completion date August 31, 2009

Study information

Verified date January 2019
Source Repros Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ZPE-201 Extension of treatment


Description:

This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months.


Recruitment information / eligibility

Status Terminated
Enrollment 18
Est. completion date August 31, 2009
Est. primary completion date August 31, 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 48 Years
Eligibility Inclusion Criteria:

- Only subjects treated in the ZPE-201 study will be allowed to enter the extension study.

- Subjects who withdrew from ZPE-201 due to lack of treatment efficacy will also be invited to participate.

Exclusion Criteria:

- All other subjects

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Proellex®
one (1) 25 mg capsule daily

Locations

Country Name City State
United States Physicians for Women Cary North Carolina
United States HWC Women's Research Center Miamisburg Ohio
United States Clinical Trials of Texas/Institute for Women's Health San Antonio Texas
United States Clinical Trials of Texas/Seven Oaks Women's Center San Antonio Texas
United States Medical Center for Clinical Research San Diego California
United States Compass Clinical Research San Ramon California
United States Advanced Clinical Therapeutics, LLC Tucson Arizona
United States Comprehensive Clinical Trials West Palm Beach Florida

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 To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily Number of participants who experienced 1 or more adverse event. 6 months
See also
  Status Clinical Trial Phase
Completed NCT01931670 - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain Phase 3
Recruiting NCT05648669 - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain Phase 3
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed NCT03690765 - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting NCT05153512 - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Completed NCT04565470 - Strategies of Self-management of Endometriosis Symptoms
Completed NCT03613298 - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement. N/A
Withdrawn NCT05568940 - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting NCT03464799 - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting NCT03002870 - Characteristics of Patient Population With Endometriosis N/A
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
Withdrawn NCT03272360 - Endometriosis Biomarker Discovery Study N/A
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
Completed NCT02387931 - Supplementation in Adolescent Girls With Endometriosis Phase 4