Back to resultsSafety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
Primary Purpose
Uterine Fibroids
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Proellex
Proellex
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine Fibroids
Eligibility 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
Sites / Locations
- Visions Clinical Research
- Insignia Clinical Research (Tampa Bay Women's Center)
- Advances in Health Inc
- The Women's Hospital of Texas, Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
50 mg Proellex®
25 mg Proellex®
Arm Description
2, 25 mg capsules
1, 25 mg capsule
Outcomes
Primary Outcome Measures
To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)
Secondary Outcome Measures
Full Information
NCT ID
NCT01069120
First Posted
February 10, 2010
Last Updated
August 5, 2014
Sponsor
Repros Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01069120
Brief Title
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
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 Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Repros stopped study due to safety and FDA placed study on hold
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Repros Therapeutics Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Safety and efficacy study of 25 and 50 mg doses of Proellex
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
Uterine Fibroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
50 mg Proellex®
Arm Type
Active Comparator
Arm Description
2, 25 mg capsules
Arm Title
25 mg Proellex®
Arm Type
Active Comparator
Arm Description
1, 25 mg capsule
Intervention Type
Drug
Intervention Name(s)
Proellex
Other Intervention Name(s)
CDB-4124
Intervention Description
2, 25 mg capsules once per day
Intervention Type
Drug
Intervention Name(s)
Proellex
Other Intervention Name(s)
CDB-4124
Intervention Description
1, 25 mg capsule once per day
Primary Outcome Measure Information:
Title
To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)
Time Frame
During two 4 month treatment periods
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre vanAS, PhD, Md
Organizational Affiliation
Repros Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Insignia Clinical Research (Tampa Bay Women's Center)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Advances in Health Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Women's Hospital of Texas, Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
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