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Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

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ClinicalTrials.gov Identifier: NCT01534208
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : July 24, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Secondary Hypogonadism
Intervention Drug: Androxal
Enrollment 499
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Androxal 12.5 mg Androxal 25 mg
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Androxal 12.5 mg daily

Androxal, oral, 12.5 mg capsule, taken once daily

Androxal 25 mg daily

Androxal, oral, 25 mg capsule, taken once daily
Period Title: Overall Study
Started 216 283
Completed 159 234
Not Completed 57 49
Reason Not Completed
Lost to Follow-up             19             14
Withdrawal by Subject             6             20
Adverse Event             15             8
Physician Decision             2             0
Lack of Efficacy             0             3
Protocol Violation             2             2
Sponsor decision             4             1
Subject relocation             2             0
Lab assessment             2             1
Eligibility error             3             0
PCP decision             1             0
Needed prohibited meds             1             0
Arm/Group Title Androxal 12.5 mg Androxal 25 mg Total
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Androxal 12.5 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Androxal 25 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

 Total of all reporting groups
Overall Number of Baseline Participants 216 283 499
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Safety population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 216 participants 283 participants 499 participants
47.5  (8.5) 49.5  (7.7) 48.6  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants 283 participants 499 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
216
 100.0%
283
 100.0%
499
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 216 participants 283 participants 499 participants
216 283 499
1.Primary Outcome
Title Change From Baseline in Total Morning Testosterone at 26 Weeks
Hide Description Changes in values from baseline of total morning testosterone levels at Week 26
Time Frame 6 months
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Intent to Treat population
Arm/Group Title Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Androxal 12.5 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Androxal 25 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Overall Number of Participants Analyzed 168 242
Mean (Standard Deviation)
Unit of Measure: ng/dL
280.9  (141.4) 214.7  (154.7)
2.Primary Outcome
Title Change From Baseline in LH
Hide Description Mean change from baseline in LH at end of treatment (26 weeks)
Time Frame 6 months
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ITT
Arm/Group Title Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Androxal 12.5 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Androxal 25 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Overall Number of Participants Analyzed 168 242
Mean (Standard Deviation)
Unit of Measure: mIu/mL
4.81  (5.69) 4.27  (4.29)
3.Primary Outcome
Title Absolute Values of Morning Testosterone
Hide Description Absolute values of morning testosterone at end of treatment (26 weeks)
Time Frame 6 months
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Hide Analysis Population Description
ITT
Arm/Group Title Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Androxal 12.5 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Androxal 25 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Overall Number of Participants Analyzed 216 283
Mean (Standard Deviation)
Unit of Measure: ng/dL
511.6  (140.8) 416.7  (154.7)
4.Primary Outcome
Title Mean Change From Baseline FPG
Hide Description Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)
Time Frame 6 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Androxal 12.5 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Androxal 25 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Overall Number of Participants Analyzed 168 242
Mean (Standard Deviation)
Unit of Measure: mg/dL
-5.4  (30.8) -5.0  (29.3)
5.Primary Outcome
Title Change From Baseline in BMI
Hide Description Mean change from baseline in BMI at end of treatment (26 weeks)
Time Frame 6 months
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ITT
Arm/Group Title Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Androxal 12.5 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Androxal 25 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Overall Number of Participants Analyzed 216 283
Mean (Standard Deviation)
Unit of Measure: kg/m2
0.2  (1.4) 0.3  (1.1)
6.Primary Outcome
Title Change From Baseline in FSH
Hide Description Change from baseline in FSH at end of treatment (26 weeks)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description:

Androxal 12.5 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Androxal 25 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Overall Number of Participants Analyzed 168 242
Mean (Standard Deviation)
Unit of Measure: U/L
5.20  (5.19) 5.42  (5.48)
Time Frame From first administration of study drug until 8 weeks after end of treatment (8 months total)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Androxal 12.5 mg Androxal 25 mg
Hide Arm/Group Description

Androxal 12.5 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Androxal 25 mg daily

Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
All-Cause Mortality
Androxal 12.5 mg Androxal 25 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
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Androxal 12.5 mg Androxal 25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/207 (2.90%)      9/283 (3.18%)    
Cardiac disorders     
Atrial flutter † 1  0/207 (0.00%)  0 1/283 (0.35%)  1
Bradycardia † 1  1/207 (0.48%)  1 0/283 (0.00%)  0
General disorders     
Chest pain † 1  1/207 (0.48%)  1 0/283 (0.00%)  0
Hepatobiliary disorders     
Biliary colic † 1  1/207 (0.48%)  1 0/283 (0.00%)  0
Cholelithiasis † 1  0/207 (0.00%)  0 1/283 (0.35%)  1
Infections and infestations     
Diverticulitis † 1  0/207 (0.00%)  0 2/283 (0.71%)  2
Injury, poisoning and procedural complications     
Food poisoning † 1  0/207 (0.00%)  0 1/283 (0.35%)  1
Nervous system disorders     
Transient ischemic attack † 1  1/207 (0.48%)  1 0/283 (0.00%)  0
Renal and urinary disorders     
Kidney infection † 1  0/207 (0.00%)  0 1/283 (0.35%)  1
Reproductive system and breast disorders     
Seminoma † 1  1/207 (0.48%)  1 0/283 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1  1/207 (0.48%)  1 0/283 (0.00%)  0
Pulmonary embolism † 1  0/207 (0.00%)  0 1/283 (0.35%)  1
Skin and subcutaneous tissue disorders     
Cellulitis † 1  0/207 (0.00%)  0 2/283 (0.71%)  2
Surgical and medical procedures     
Knee arthroplasy † 1  1/207 (0.48%)  1 0/283 (0.00%)  0
Vascular disorders     
Deep vein thrombosis † 1  1/207 (0.48%)  1 1/283 (0.35%)  1
Hypotension † 1  1/207 (0.48%)  1 0/283 (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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/207 (31.88%)      92/283 (32.51%)    
General disorders     
Hot flush † 1  2/207 (0.97%)  9/283 (3.18%) 
Infections and infestations     
Upper respiratory tract infection † 1  26/207 (12.56%)  26 27/283 (9.54%)  27
Influenza † 1  7/207 (3.38%)  5/283 (1.77%) 
Sinusitis † 1  7/207 (3.38%)  6/283 (2.12%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms † 1  10/207 (4.83%)  12/283 (4.24%) 
Nervous system disorders     
Headache † 1  12/207 (5.80%)  23/283 (8.13%) 
Dizziness † 1  6/207 (2.90%)  5/283 (1.77%) 
Renal and urinary disorders     
Pollakiuria † 1  6/207 (2.90%)  5/283 (1.77%) 
†
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
Layout table for Results Point of Contact information
Name/Title: Jennifer Wike
Organization: Repros Therapeutics Inc.
Phone: 2817193402
EMail: jwike@reprosrx.com
Layout table for additonal information
Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01534208    
Other Study ID Numbers: ZA-300
First Submitted: February 9, 2012
First Posted: February 16, 2012
Results First Submitted: June 27, 2014
Results First Posted: July 24, 2014
Last Update Posted: July 24, 2014