Trial record 15 of 176 for:
Leiomyoma: Clinical Trials
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
This study has been completed.
Sponsor:
Repros Therapeutics Inc.
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00882258
First received: April 14, 2009
Last updated: February 12, 2010
Last verified: February 2010
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Purpose
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Fibroids |
Drug: Proellex 12.5 mg Drug: Proellex 25 mg Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata |
Resource links provided by NLM:
Further study details as provided by Repros Therapeutics Inc.:
Primary Outcome Measures:
- To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata [ Time Frame: 91 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata [ Time Frame: 91 days ] [ Designated as safety issue: No ]
| Enrollment: | 144 |
| Study Start Date: | March 2006 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Proellex 12.5 mg
|
Drug: Proellex 12.5 mg
12.5 mg administered orally daily
Other Name: CDB-4124
|
|
Experimental: 2
Proellex 25 mg
|
Drug: Proellex 25 mg
25 mg administered orally daily
Other Name: CDB-4124
|
|
Placebo Comparator: 3
Placebo
|
Drug: Placebo
Administered orally daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound.
- Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain
Exclusion Criteria:
Post-menopausal women, as defined as one or more of the following:
- six months or more (immediately prior to Screening visit) without a menstrual period, or
- prior hysterectomy and/or oophorectomy
- Subjects with documented endometriosis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882258
Locations
| United States, Alabama | |
| Alabama Clinical Therapeutics, LLC | |
| Birmingham, Alabama, United States, 35235 | |
| United States, Arizona | |
| Women's Health Research | |
| Phoenix, Arizona, United States, 85015 | |
| Arizona Wellness Centre for Women | |
| Phoenix, Arizona, United States, 85032 | |
| Visions Clinical Research Tuscon | |
| Tuscon, Arizona, United States, 85712 | |
| United States, California | |
| Women's Health Care, Inc. | |
| San Diego, California, United States, 92123 | |
| Medical Centre for Clinical Research | |
| San Diego, California, United States, 92108 | |
| United States, Colorado | |
| Downtown Women's Health Care | |
| Denver, Colorado, United States, 80218 | |
| United States, Florida | |
| Visions Clinical Research | |
| Boynton Beach, Florida, United States, 33437 | |
| Miami Research Associates, Women's Health Studies | |
| Miami, Florida, United States, 33143 | |
| Insignia Clinical Research (Tampa Bay Women's Center) | |
| Tampa, Florida, United States, 33607 | |
| United States, Nevada | |
| Caring for Women | |
| Las Vegas, Nevada, United States, 89106 | |
| Affiliated Clinical Research, Inc. | |
| Las Vegas, Nevada, United States, 89128 | |
| United States, South Carolina | |
| SC Clinical Research Center | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Texas | |
| Advances in Health Inc. | |
| Houston, Texas, United States, 77030 | |
| Obstetrical & Gynecolgical Associates, PA (OGA) | |
| Houston, Texas, United States, 77054 | |
| United States, Washington | |
| Women's Clinical Research Centre | |
| Seattle, Washington, United States, 98105 | |
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
| Study Director: | Andre VanAs, PhD, MD | Repros Therapeutics Inc. |
More Information
No publications provided
| Responsible Party: | Andre van As, M.D. Ph.D., Repros Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00882258 History of Changes |
| Other Study ID Numbers: | ZPU-003 |
| Study First Received: | April 14, 2009 |
| Last Updated: | February 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Repros Therapeutics Inc.:
|
Uterine fibroids |
Additional relevant MeSH terms:
|
Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 19, 2013