A Study Evaluating the Safety of 25 and 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
This study has been terminated.
(Repros stopped study due to safety and FDA placed study on hold)
Sponsor:
Repros Therapeutics Inc.
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01069120
First received: February 10, 2010
Last updated: February 16, 2010
Last verified: February 2010
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Purpose
The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Fibroids |
Drug: Proellex |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III, Open-Label, Parallel, Randomized, Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304 |
Further study details as provided by Repros Therapeutics Inc.:
Primary Outcome Measures:
- To assess the incidence of adverse events (AE) and serious adverse events (SAEs) [ Time Frame: During two 4 month treatment periods ] [ Designated as safety issue: Yes ]
- To assess change from baseline of endometrial histology and thickness, laboratory and endocrinology assessments, vital signs and electrocardiogram for each treatment group and between treatments [ Time Frame: During two 4 month treatment periods ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess change from baseline of BMD for spine, femoral neck and total hip, as noted by changes in DEXA scan in normal and osteopenic groups for each treatment group and between treatments. [ Time Frame: During two 4 month treatment periods ] [ Designated as safety issue: Yes ]
| Enrollment: | 27 |
| Study Start Date: | April 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 50 mg Proellex®
2, 25 mg capsules
|
Drug: Proellex
2, 25 mg capsules once per day
Other Name: CDB-4124
|
|
Active Comparator: 25 mg Proellex®
1, 25 mg capsule
|
Drug: Proellex
1, 25 mg capsule once per day
Other Name: CDB-4124
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
- Subject has a menstrual cycle lasting from 20 to 40 days.
- Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Exclusion Criteria:
- Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
- Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069120
Locations
| United States, Florida | |
| Visions Clinical Research | |
| Boynton Beach, Florida, United States, 33472 | |
| Insignia Clinical Research (Tampa Bay Women's Center) | |
| Tampa, Florida, United States, 33067 | |
| United States, Texas | |
| The Women's Hospital of Texas, Clinical Research Center | |
| Houston, Texas, United States, 77054 | |
| Advances in Health Inc | |
| Houston, Texas, United States, 77030 | |
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: | NCT01069120 History of Changes |
| Other Study ID Numbers: | ZPU-307 |
| Study First Received: | February 10, 2010 |
| Last Updated: | February 16, 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