Determination of the Lowest, Safe and Effective Dose of Proellex

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01187043
First received: August 20, 2010
Last updated: June 27, 2014
Last verified: June 2014
Results First Received: June 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Amenorrhea
Intervention: Drug: Proellex

  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
ARM 1

1 mg Proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)

ARM 2

3 mg Proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)

ARM 3

6 mg Proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)

ARM 4

9 mg Proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)

ARM 5

12 mg proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)


Participant Flow:   Overall Study
    ARM 1     ARM 2     ARM 3     ARM 4     ARM 5  
STARTED     12     10     12     12     12  
COMPLETED     11     10     8     12     10  
NOT COMPLETED     1     0     4     0     2  
Adverse Event                 0                 0                 0                 0                 1  
Unable to make scheduled visits                 1                 0                 4                 0                 1  



  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.
ITT

Reporting Groups
  Description
ARM 1

1 mg Proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)

ARM 2

3 mg Proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)

ARM 3

6 mg Proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)

ARM 4

9 mg Proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)

ARM 5

12 mg proellex

Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)

Total Total of all reporting groups

Baseline Measures
    ARM 1     ARM 2     ARM 3     ARM 4     ARM 5     Total  
Number of Participants  
[units: participants]
  12     10     12     12     12     58  
Age  
[units: years]
Mean ± Standard Deviation
  37.4  ± 7.8     38.5  ± 7.6     37.1  ± 8.6     34.4  ± 8.3     36.3  ± 7.0     36.7  ± 7.8  
Gender  
[units: participants]
           
Female     12     10     12     12     12     58  
Male     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
           
United States     12     10     12     12     12     58  



  Outcome Measures

1.  Primary:   Induction Amenorrhea   [ Time Frame: 10 weeks ]


  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
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  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: NCT01187043     History of Changes
Other Study ID Numbers: ZP-204
Study First Received: August 20, 2010
Results First Received: June 23, 2014
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration