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| Sponsored by: |
Repros Therapeutics Inc. |
| Information provided by: | Repros Therapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT00556075 |
Purpose
The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.
| Condition | Intervention | Phase |
|
Endometriosis |
Drug: Proellex 25 mg Drug: Placebo Drug: Proellex 50 mg |
Phase II |
| MedlinePlus related topics: | Endometriosis |
| ChemIDplus related topics: | Progesterone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II, Three-Arm, Parallel Design, Dose-Ranging Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis |
| Estimated Enrollment: | 75 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | October 2008 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
C: Placebo Comparator
Placebo
|
Drug: Placebo
1 capsule daily for 4 months
|
|
A: Experimental
Proellex 25 mg
|
Drug: Proellex 25 mg
1 capsule daily for 4 months
|
|
B: Experimental
Proellex 50 mg
|
Drug: Proellex 50 mg
2 capsules daily for 4 months
|
Eligibility
| Ages Eligible for Study: | 18 Years to 48 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: John Weiler, MD | 319-626-8888 | jweiler@compleware.com |
| Contact: Michelle Moore | 319-626-8888 | mmoore@compleware.com |
| United States, Arizona | |||||
| Advanced Clinical Therapeutics, LLC | Recruiting | ||||
| Tucson, Arizona, United States, 85712 | |||||
| Contact: Joanie Seibold 520-323-9601 jseibold@advancedtherapies.com | |||||
| Principal Investigator: Walter Patton, MD | |||||
| United States, Arkansas | |||||
| Lynn Institute of the Ozarks | Recruiting | ||||
| Little Rock, Arkansas, United States, 72205 | |||||
| Contact: Holly Jarrell 501-975-2000 hjarrell@lhsi.net | |||||
| Principal Investigator: Caroline May, MD | |||||
| United States, California | |||||
| Compass Clinical Research | Recruiting | ||||
| San Ramon, California, United States, 94583 | |||||
| Contact: Jennifer McWatters 925-973-5012 jennifer.mcwatters@integramed.com | |||||
| Principal Investigator: Donald Galen, MD | |||||
| Medical Center for Clinical Research | Recruiting | ||||
| San Diego, California, United States, 92108 | |||||
| Contact: Karen Wilborn-Mylerberg 619-521-2830 kwilborn@redwire.net | |||||
| Principal Investigator: William Koltun, MD | |||||
| United States, Florida | |||||
| Comprehensive Clinical Trials | Recruiting | ||||
| West Palm Beach, Florida, United States, 33409 | |||||
| Contact: Virginia Piechocniski 561-478-3177 regulatory@cctllc.net | |||||
| Principal Investigator: Ronald Ackerman, MD | |||||
| Altus Research | Recruiting | ||||
| Lake Worth, Florida, United States, 33461 | |||||
| Contact: Cynthia Abath 561-296-7397 cindyabath@aol.com | |||||
| Principal Investigator: Samuel Lederman, MD | |||||
| United States, Iowa | |||||
| Medical Associates | Recruiting | ||||
| Dubuque, Iowa, United States, 52002 | |||||
| Contact: Maureen Runde 563-584-4139 mmrunde@mahealthcare.com | |||||
| Principal Investigator: Trupti Mehta, MD | |||||
| United States, North Carolina | |||||
| Wake Research Associates | Recruiting | ||||
| Raleigh, North Carolina, United States, 27612 | |||||
| Contact: Marsha Peery 919-781-2514 mpeery@wakeresearch.com | |||||
| Principal Investigator: Pouru Bhiwandiwalla, MD | |||||
| Physicians for Women | Recruiting | ||||
| Cary, North Carolina, United States, 27511 | |||||
| Contact: Marcia Ramirez 919-678-6907 marciar@physicians-for-women.com | |||||
| Principal Investigator: Geoff Seidel, MD | |||||
| United States, Ohio | |||||
| HWC Women's Research Center | Recruiting | ||||
| Miamisburg, Ohio, United States, 45342 | |||||
| Contact: Angela Shields 937-866-1187 ashields@hwcwrc.com | |||||
| Principal Investigator: James Huey, MD | |||||
| Rapid Medical Research, Inc. | Recruiting | ||||
| Cleveland, Ohio, United States, 44122 | |||||
| Contact: Clauida Lanesa 216-539-8384 claudia@rapidmedicalresearch.com | |||||
| Principal Investigator: Mira Baron, MD | |||||
| United States, South Carolina | |||||
| SC Clinical Research Center, LLC | Recruiting | ||||
| Columbia, South Carolina, United States, 29201 | |||||
| Contact: Margaret Holt 803-988-1438 pholt@scclinicalresearch.com | |||||
| Principal Investigator: Myles Davis, MD | |||||
| Greenville Pharma Research | Recruiting | ||||
| Greenville, South Carolina, United States, 29615 | |||||
| Contact: Steve Clemons 864-770-0892 sclemons@greenvilleMedResearch.com | |||||
| Principal Investigator: David Godwin, MD | |||||
| Gaffney Pharmaceutical Research | Recruiting | ||||
| Gaffney, South Carolina, United States, 29340 | |||||
| Contact: Tammy Tate 864-488-1283 ttategpr@bellsouth.net | |||||
| Principal Investigator: Steven Lewis, MD | |||||
| United States, Texas | |||||
| Advanced Research Associates | Recruiting | ||||
| Corpus Christi, Texas, United States, 78414 | |||||
| Contact: Bonnie Gutierrez 361-906-1277 ext 104 bonnie@araresearch.com | |||||
| Principal Investigator: Charles Eubank, MD | |||||
| Clinical Trials of Texas/Seven Oaks Women's Center | Recruiting | ||||
| San Antonio, Texas, United States, 78229 | |||||
| Contact: Mary Jo Perez-Jenkins 210-949-0122 mjenkins@cttexas.com | |||||
| Principal Investigator: Brian Harle, MD | |||||
| Clinical Trials of Texas/Institute for Women's Health | Recruiting | ||||
| San Antonio, Texas, United States, 78229 | |||||
| Contact: Kate Blair 210-949-0122 kblair@cttexas.com | |||||
| Principal Investigator: Jose Ruiz, MD | |||||
| Repros Therapeutics Inc. |
| Study Director: | Andre vanAs, MD, PhD | Repros Therapeutics Inc. |
More Information
| Responsible Party: | Andre vanAs, MD, PhD ( Repros Therapeutics Inc. ) |
| Study ID Numbers: | ZPE-201 |
| First Received: | November 7, 2007 |
| Last Updated: | May 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00556075 |
| Health Authority: | United States: Food and Drug Administration |
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