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Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism

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ClinicalTrials.gov Identifier: NCT01739595
Recruitment Status : Completed
First Posted : December 3, 2012
Results First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Secondary Hypogonadism
Interventions Drug: enclomiphene citrate
Drug: Placebo
Enrollment 181
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Androxal 12.5 mg Androxal 25 mg Placebo
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Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Placebo oral capsules taken one time daily

Placebo: Oral capsule taken one time daily for 3 months
Period Title: Overall Study
Started 112 22 47
Completed 99 21 45
Not Completed 13 1 2
Reason Not Completed
Adverse Event             3             0             0
Lost to Follow-up             2             0             0
Withdrawal by Subject             2             1             2
Eligibility issue             3             0             0
Protocol Violation             1             0             0
Lab assessment             1             0             0
Drug discrepancy             1             0             0
Arm/Group Title Androxal 12.5 mg Androxal 25 mg Placebo Total
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Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Placebo oral capsules taken one time daily

Placebo: Oral capsule taken one time daily for 3 months

 Total of all reporting groups
Overall Number of Baseline Participants 112 22 47 181
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Safety population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 22 participants 47 participants 181 participants
44.6  (9.6) 45.8  (8.6) 43.6  (10.5) 44.5  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 22 participants 47 participants 181 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
112
 100.0%
22
 100.0%
47
 100.0%
181
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 112 participants 22 participants 47 participants 181 participants
112 22 47 181
1.Primary Outcome
Title Subjects With Testosterone in Normal Range After Treatment
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Proportion (percent) of subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg was calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.

If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the coprimary endpoint based on the Cavg for testosterone would have been achieved.

FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated.
Time Frame 3 months
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ITT population.
Arm/Group Title Androxal Subjects Pooled
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Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months
Overall Number of Participants Analyzed 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Subjects
81.3
(73.9 to 87.0)
2.Primary Outcome
Title Change in Sperm Concentration
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Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.

The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations.
Time Frame 3 months
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ITT
Arm/Group Title Androxal Subjects Pooled Placebo
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Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Placebo oral capsules taken one time daily

Placebo: Oral capsule taken one time daily for 3 months
Overall Number of Participants Analyzed 134 47
Measure Type: Number
Unit of Measure: percentage of subjects
14.2 4.3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Androxal 12.5 mg Androxal 25 mg Placebo
Hide Arm/Group Description

Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily

enclomiphene citrate: oral, capsules, taken one time daily, for 3 months

Placebo oral capsules taken one time daily

Placebo: Oral capsule taken one time daily for 3 months
All-Cause Mortality
Androxal 12.5 mg Androxal 25 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
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Androxal 12.5 mg Androxal 25 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/112 (0.89%)      0/22 (0.00%)      0/47 (0.00%)    
Gastrointestinal disorders       
Abdominal pain † 1  1/112 (0.89%)  1 0/22 (0.00%)  0 0/47 (0.00%)  0
Diarrhoea † 1  1/112 (0.89%)  1 0/22 (0.00%)  0 0/47 (0.00%)  0
Vomiting † 1  1/112 (0.89%)  1 0/22 (0.00%)  0 0/47 (0.00%)  0
General disorders       
Asthenia † 1  1/112 (0.89%)  1 0/22 (0.00%)  0 0/47 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Androxal 12.5 mg Androxal 25 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/112 (18.75%)      16/22 (72.73%)      10/47 (21.28%)    
Gastrointestinal disorders       
Nausea † 1  4/112 (3.57%)  1/22 (4.55%)  3/47 (6.38%) 
Hiatus hernia † 1  0/112 (0.00%)  1/22 (4.55%)  0/47 (0.00%) 
Vomiting † 1  2/112 (1.79%)  1/22 (4.55%)  2/47 (4.26%) 
General disorders       
Fatigue † 1  2/112 (1.79%)  1/22 (4.55%)  2/47 (4.26%) 
Pyrexia † 1  0/112 (0.00%)  1/22 (4.55%)  0/47 (0.00%) 
Infections and infestations       
Body tinea † 1  0/112 (0.00%)  1/22 (4.55%)  0/47 (0.00%) 
Infection † 1  0/112 (0.00%)  1/22 (4.55%)  0/47 (0.00%) 
Influenza † 1  0/112 (0.00%)  1/22 (4.55%)  0/47 (0.00%) 
URI † 1  5/112 (4.46%)  0/22 (0.00%)  1/47 (2.13%) 
Sinusitis † 1  0/112 (0.00%)  1/22 (4.55%)  1/47 (2.13%) 
Investigations       
Blood testosterone decreased † 1  0/112 (0.00%)  1/22 (4.55%)  0/47 (0.00%) 
Blood triglycerides increased † 1  0/112 (0.00%)  1/22 (4.55%)  0/47 (0.00%) 
Hemoglobin increased † 1  0/112 (0.00%)  1/22 (4.55%)  0/47 (0.00%) 
Weight decreased † 1  0/112 (0.00%)  1/22 (4.55%)  0/47 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite † 1  0/112 (0.00%)  1/22 (4.55%)  0/47 (0.00%) 
Nervous system disorders       
Headache † 1  7/112 (6.25%)  0/22 (0.00%)  1/47 (2.13%) 
Skin and subcutaneous tissue disorders       
Night sweats † 1  1/112 (0.89%)  1/22 (4.55%)  0/47 (0.00%) 
Rash papular † 1  0/112 (0.00%)  1/22 (4.55%)  0/47 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[Not Specified]
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.
Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights
Results Point of Contact
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Name/Title: Jennifer Wike
Organization: Repros Therapeutics Inc
Phone: 2817193402
EMail: jwike@reprosrx.com
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Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01739595    
Other Study ID Numbers: ZA-302
First Submitted: November 29, 2012
First Posted: December 3, 2012
Results First Submitted: June 26, 2014
Results First Posted: May 27, 2015
Last Update Posted: May 27, 2015