A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203

Study Overview
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Brief Summary
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The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.

Official Title
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A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203

Conditions
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Hypogonadism, Low Testosterone

Intervention / Treatment
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* Drug: Androxal (enclomiphene citrate)
* Drug: Testim (topical testosterone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Successful completion of ZA-203 Ability to understand and provide written informed consent Agreement to use a condom, and with a fertile female partner, another form of contraception Agreement to provide semen samples in the clinic Exclusion Criteria: Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Androxal<br>Androxal (enclomiphene citrate)12.5 mg or 25 mg | Drug: Androxal (enclomiphene citrate)<br>* capsules oral 1x a day 1 year<br>* Other names: enclomiphene citrate;|
| Active Comparator: Testim (topical testosterone)<br> | Drug: Testim (topical testosterone)<br>* topical 1 tube 1x a day 1 year<br>* Other names: testosterone gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in testosterone comparing Androxal to Testim | Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) | Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim | 1 year | 
| Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) | Reproductive safety will be assessed by changes in values from baseline of semen volume, and sperm concentration, total count, morphology and motility at baseline (Visit 1), month 4, 6 and 12 comparing Androxal 12.5 and 25 mg to Testim | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypogonadism, low testosterone, low T