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Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01270841
First received: January 4, 2011
Last updated: June 27, 2014
Last verified: June 2014
Results First Received: June 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Secondary Hypogonadism
Interventions: Drug: Placebo
Drug: topical testosterone
Drug: Androxal

  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
Placebo

Placebo

Placebo: Placebo capsule 1x daily for 3 months

Testim (Topical Testosterone)

Testim (topical testosterone)

topical testosterone: testosterone gel applied 1x daily for 3 months

Androxal 12.5 mg

Androxal 12.5 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal 25 mg

Androxal 25 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months


Participant Flow:   Overall Study
    Placebo     Testim (Topical Testosterone)     Androxal 12.5 mg     Androxal 25 mg  
STARTED     29     33     29     33  
COMPLETED     16     19     18     20  
NOT COMPLETED     13     14     11     13  
Adverse Event                 0                 1                 0                 3  
Withdrawal by Subject                 3                 2                 3                 3  
Lost to Follow-up                 3                 1                 4                 2  
Physician Decision                 0                 1                 0                 0  
Did not qualify                 6                 3                 4                 5  
Protocol Violation                 1                 5                 0                 0  
Enrolled in error                 0                 1                 0                 0  



  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.
Safety population

Reporting Groups
  Description
Placebo

Placebo

Placebo: Placebo capsule 1x daily for 3 months

Testim (Topical Testosterone)

Testim (topical testosterone)

topical testosterone: testosterone gel applied 1x daily for 3 months

Androxal 12.5 mg

Androxal 12.5 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal 25 mg

Androxal 25 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Total Total of all reporting groups

Baseline Measures
    Placebo     Testim (Topical Testosterone)     Androxal 12.5 mg     Androxal 25 mg     Total  
Number of Participants  
[units: participants]
  28     33     27     33     121  
Age  
[units: years]
Mean ± Standard Deviation
  51.6  ± 11.7     52.0  ± 10.6     49.7  ± 11.6     49.2  ± 10.9     50.6  ± 11.2  
Gender  
[units: participants]
         
Female     0     0     0     0     0  
Male     28     33     27     33     121  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     1     1     2  
Asian     4     6     2     6     18  
Native Hawaiian or Other Pacific Islander     0     0     1     0     1  
Black or African American     7     4     5     6     22  
White     17     23     18     20     78  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     28     33     27     33     121  
BMI  
[units: kg/m2]
Mean ± Standard Deviation
  30.9  ± 4.2     33.1  ± 5.9     32.6  ± 5.2     31.7  ± 4.9     32.1  ± 5.1  



  Outcome Measures
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1.  Primary:   Change in Total Morning Testosterone   [ Time Frame: 3 months ]

2.  Secondary:   Change in Luteinizing Hormone Levels   [ Time Frame: 3 months ]

3.  Secondary:   Change in FSH After 3 Months of Treatment   [ Time Frame: 3 months ]

4.  Secondary:   Reproductive Safety   [ 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
No text entered.


  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 by Repros Therapeutics Inc.

Publications automatically indexed to this study:

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01270841     History of Changes
Other Study ID Numbers: ZA-203
Study First Received: January 4, 2011
Results First Received: June 18, 2014
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration