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Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01069120
Recruitment Status : Terminated (Repros stopped study due to safety and FDA placed study on hold)
First Posted : February 17, 2010
Results First Posted : August 21, 2014
Last Update Posted : August 21, 2014
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Brief Summary:
Safety and efficacy study of 25 and 50 mg doses of Proellex

Condition or disease Intervention/treatment Phase
Uterine Fibroids Drug: Proellex Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® in the Treatment of Women Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Study Start Date : April 2009
Primary Completion Date : August 2009
Study Completion Date : August 2009

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) [ Time Frame: During two 4 month treatment periods ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Advances in Health Inc
Houston, Texas, United States, 77030
The Women's Hospital of Texas, Clinical Research Center
Houston, Texas, United States, 77054
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre vanAS, PhD, Md Repros Therapeutics Inc.

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01069120     History of Changes
Other Study ID Numbers: ZPU-307
First Posted: February 17, 2010    Key Record Dates
Results First Posted: August 21, 2014
Last Update Posted: August 21, 2014
Last Verified: August 2014

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