Two Year Extension Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Pre-Menopausal Women With Symptomatic Leiomyomata Who Have Previously Completed Study ZPU 003

This study has been completed.
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00958334
First received: August 11, 2009
Last updated: December 9, 2010
Last verified: December 2010
Results First Received: August 26, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Uterine Fibroids
Interventions: Drug: Proellex®
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
Proellex 25 mg Proellex® 12.5 mg orally capsules BID
Proellex 12.5 mg Proellex® 12.5 mg capsules orally QD
Placebo Comparator Placebo capsules orally QD

Participant Flow:   Overall Study
    Proellex 25 mg     Proellex 12.5 mg     Placebo Comparator  
STARTED     22     22     21  
COMPLETED     8     5     8  
NOT COMPLETED     14     17     13  



  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.
No text entered.

Reporting Groups
  Description
Proellex 25 mg Proellex® 12.5 mg twice daily
Proellex 12.5 mg Proellex® 12.5 mg once daily
Placebo Comparator No text entered.
Total Total of all reporting groups

Baseline Measures
    Proellex 25 mg     Proellex 12.5 mg     Placebo Comparator     Total  
Number of Participants  
[units: participants]
  22     22     21     65  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     22     22     21     65  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.5  ± 5.55     42.6  ± 5.38     40.6  ± 6.48     41.6  ± 5.78  
Gender  
[units: participants]
       
Female     22     22     21     65  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     22     22     21     65  



  Outcome Measures

1.  Primary:   The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext.   [ Time Frame: baseline, 14 months (3-4 cycles), 17 months ]

2.  Secondary:   Change From Baseline of ZPU-003 Ext to 14 Months in Subject's Menstrual Pictograms(Subjects Evaluable for Menorrhagia Only)   [ Time Frame: baseline and 14 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Ronald Wiehle, PhD
Organization: Repros Therapeutics, Inc
phone: 281.719.3406
e-mail: rwiehle@reprosrx.com


No publications provided


Responsible Party: Andre vanAs, MD, PhD, Repros Therapeutics
ClinicalTrials.gov Identifier: NCT00958334     History of Changes
Other Study ID Numbers: ZPU-003 Ext
Study First Received: August 11, 2009
Results First Received: August 26, 2010
Last Updated: December 9, 2010
Health Authority: United States: Food and Drug Administration