To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00706719
First received: June 25, 2008
Last updated: July 22, 2015
Last verified: July 2015
Results First Received: August 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Secondary Hypogonadism
Interventions: Drug: 25 mg Androxal
Drug: Testim 1%

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group A Testim (Topical Testosterone) 1% Testim gel applied once daily
Group B Androxal no Washout 25 mg Androxal capsules once daily in men who have not previously washed out topical testosterone
Group C Androxal With Wash Out 25 mg capsules once daily in men who have previously had a 3 month wash out of topical testosterone

Participant Flow:   Overall Study
    Group A Testim (Topical Testosterone)     Group B Androxal no Washout     Group C Androxal With Wash Out  
STARTED     5     7     5  
COMPLETED     5     6     1  
NOT COMPLETED     0     1     4  



  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.
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Reporting Groups
  Description
Group A Testim 1% Testim gel applied daily
Group B Androxal no Wash Out 25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
Group C Androxal Wash Out 25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
Total Total of all reporting groups

Baseline Measures
    Group A Testim     Group B Androxal no Wash Out     Group C Androxal Wash Out     Total  
Number of Participants  
[units: participants]
  5     7     5     17  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     5     7     5     17  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  54.4  (4.88)     48.9  (8.99)     56.4  (23.8)     52.7  (7.72)  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     5     7     5     17  
Region of Enrollment  
[units: participants]
       
United States     5     7     5     17  



  Outcome Measures
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1.  Primary:   Sperm Concentration   [ Time Frame: Baseline, Month 3, Month 6, Follow-Up (Month 7) ]

2.  Primary:   Motile Total Sperm Count   [ Time Frame: Baseline, Month 3, Month 6, Follow-Up (Month 7) ]

3.  Primary:   Semen Volume   [ Time Frame: Baseline, Month 3, Month 6, Follow-Up (Month 7) ]

4.  Secondary:   Luteinizing Hormone (LH) Levels   [ Time Frame: Baseline, Month 3, Month 6, Follow-Up (Month 7) ]

5.  Secondary:   Follicle Stimulating Hormone (FSH) Levels   [ Time Frame: Baseline, Month 3, Month 6, Follow-Up (Month 7) ]


  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: Ronald Wiehle, PhD
Organization: Repros Therapeutics, Inc
phone: 281.719.3406
e-mail: rwiehle@reprosrx.com


No publications provided


Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00706719     History of Changes
Other Study ID Numbers: ZA-201
Study First Received: June 25, 2008
Results First Received: August 25, 2010
Last Updated: July 22, 2015
Health Authority: United States: Food and Drug Administration