Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

Study Overview
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Brief Summary
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Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.

Official Title
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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

Conditions
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Secondary Hypogonadism

Intervention / Treatment
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* Drug: Androxal
* Drug: Androxal
* Drug: AndroGel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Total serum testosterone concentrations < 300 ng/dL at baseline Exclusion Criteria: Presence or history of prostate cancer Elevated PSA > 3.5 ng/mL Additional inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Androxal™ 12.5 mg | Drug: Androxal<br>* 12.5 mg once daily<br>* Other names: Enclomiphene citrate;|
| Experimental: 2<br>Androxal™ 25 mg | Drug: Androxal<br>* 25 mg once daily<br>* Other names: Enclomiphene citrate;|
| Active Comparator: 3<br>AndroGel® | Drug: AndroGel<br>* 5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert.<br>|
| Placebo Comparator: 4<br>Placebo | Drug: Placebo<br>* 1 capsule daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of Androxal™ administered in men with secondary hypogonadism |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel® |  | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary Hypogonadism