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The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01386606
First received: June 29, 2011
Last updated: August 21, 2015
Last verified: August 2015
Results First Received: June 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Secondary Hypogonadism
Interventions: Drug: Androxal (enclomiphene citrate)
Drug: Testosterone

  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
Androxal 6.25 mg

enclomiphene citrate: capsule oral

1X a day 6 weeks

Androxal 12.5 mg

enclomiphene citrate: capsule oral

1X a day 6 weeks

Androxal 25 mg

enclomiphene citrate: capsule oral

1X a day 6 weeks

AndroGel

AndroGel 5G topical testosterone

Testosterone: topical gel

1X a day 6 weeks


Participant Flow:   Overall Study
    Androxal 6.25 mg   Androxal 12.5 mg   Androxal 25 mg   AndroGel
STARTED   16   14   16   14 
COMPLETED   12   10   13   13 
NOT COMPLETED   4   4   3   1 
Adverse Event                0                1                0                0 
Withdrawal by Subject                0                1                1                0 
Protocol Violation                1                0                1                1 
Lost to Follow-up                2                0                0                0 
Subject incarcerated                0                1                0                0 
Unable to draw PK                1                0                0                0 
T levels too high                0                1                1                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.
The baseline analysis consisted of all subjects enrolled.

Reporting Groups
  Description
Androxal 6.25 mg

enclomiphene citrate: capsule oral

1X a day 6 weeks

Androxal 12.5 mg

enclomiphene citrate: capsule oral

1X a day 6 weeks

Androxal 25 mg

enclomiphene citrate: capsule oral

1X a day 6 weeks

AndroGel

AndroGel 5G topical testosterone

Testosterone: topical gel

1X a day 6 weeks

Total Total of all reporting groups

Baseline Measures
   Androxal 6.25 mg   Androxal 12.5 mg   Androxal 25 mg   AndroGel   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   14   16   14   60 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.4  (8.8)   51.7  (9.2)   51.8  (13.0)   53.5  (9.8)   52.6  (10.2) 
Gender 
[Units: Participants]
         
Female   0   0   0   0   0 
Male   16   14   16   14   60 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   0   0   0   0   0 
Asian   0   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
Black or African American   8   8   10   2   28 
White   8   6   6   12   32 
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   16   14   16   14   60 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 33.3  (5.9)   31.2  (6.6)   31.6  (6.3)   31.0  (6.1)   31.8  (6.1) 


  Outcome Measures
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1.  Primary:   24 Hour Average and Maximum Testosterone Concentration   [ Time Frame: Baseline and Week 6 ]

2.  Secondary:   Change in Leuteinizing Hormone (LH)   [ Time Frame: Baseline, Week 2, Week 4, Week 6 ]

3.  Secondary:   Change in Follicle Stimulating Hormone (FSH)   [ Time Frame: Baseline, Week 2, Week 4, Week 6 ]

4.  Other Pre-specified:   Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.   [ Time Frame: Week 6 ]

5.  Other Pre-specified:   Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.   [ Time Frame: Week 6 ]

6.  Other Pre-specified:   Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.   [ Time Frame: Week 6 ]

7.  Post-Hoc:   Morning Testosterone Correlated With Serial Testosterone.   [ Time Frame: Week 6 ]


  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



Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01386606     History of Changes
Other Study ID Numbers: ZA-204
Study First Received: June 29, 2011
Results First Received: June 13, 2014
Last Updated: August 21, 2015
Health Authority: United States: Food and Drug Administration