Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids

This study has been terminated.
(Repros stopped study for safety and FDA put study on hold because of safety.)
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00702702
First received: June 18, 2008
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: June 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Uterine Fibroids
Anemia
Interventions: Drug: Proellex 25 mg
Drug: Proellex 50 mg
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Groups Proellex 25 mg, 50 mg or placebo

Participant Flow:   Overall Study
    All Groups  
STARTED     56  
COMPLETED     0  
NOT COMPLETED     56  
Study prematurely terminated                 56  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Study prematurely terminated for safety reasons

Reporting Groups
  Description
25 mg Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
50 mg Proellex 50 mg, 1 - 50 mg capsule and 1 placebo capsule daily for 3 months
Placebo Placebo, 2 placebo capsules daily for 3 months
Total Total of all reporting groups

Baseline Measures
    25 mg     50 mg     Placebo     Total  
Number of Participants  
[units: participants]
  0     0     0     0  
Age  
[units: participants]
       
<=18 years                  
Between 18 and 65 years                  
>=65 years                  
Gender  
[units: participants]
       
Female                  
Male                  
Region of Enrollment  
[units: participants]
       
United States                  



  Outcome Measures

1.  Primary:   Change in Hemoglobin vs Placebo   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Jennifer L. Wike
Organization: Repros Therapeutics Inc.
phone: 281-719-3402
e-mail: jwike@reprosrx.com


No publications provided


Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00702702     History of Changes
Other Study ID Numbers: ZPU-301
Study First Received: June 18, 2008
Results First Received: June 23, 2014
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration