To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

Study Overview
=================
Brief Summary
-----------------
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.

Detailed Description
-----------------
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. A maximum of twelve subjects per group were randomized to daily treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was later amended to include a treatment group who received Androxal after a 3 month wash out period.

Official Title
-----------------
A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated With Topical Testosterone.

Conditions
-----------------
Secondary Hypogonadism

Intervention / Treatment
-----------------
* Drug: 25 mg Androxal
* Drug: Testim 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH. Subjects must have been treated with a topical testosterone replacement therapy (typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more than 2 years. Exclusion Criteria: A history of idiopathic infertility due to primary hypogonadism, testicular failure, Kallmann's syndrome or any other infertility condition. Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile other than AIHH. Men with a history of, known, or suspected prostate disease not ruled out by a prostate biopsy, or a prostate specific antigen (PSA)>3.6 or clinical suspicion of current prostate disease. Men with a hematocrit in excess of 50 % or hemoglobin >17 g/dl

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25 mg Androxal no wash out<br>1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period | Drug: 25 mg Androxal<br>* 25 mg Androxal capsules, 1 capsule daily for 6 months<br>* Other names: Enclomiphene citrate;|
| Active Comparator: Testim 1% (topical testosterone)<br>Testim 1% Gel applied topically for 6 months | Drug: Testim 1%<br>* Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months<br>* Other names: Topical testosterone;|
| Experimental: 25 mg Androxal wash out<br>1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone | Drug: 25 mg Androxal<br>* 25 mg Androxal capsules, 1 capsule daily for 6 months<br>* Other names: Enclomiphene citrate;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm Concentration | Total sperm concentration was measured. | Baseline, Month 3, Month 6, Follow-Up (Month 7) | 
| Motile Total Sperm Count | Motile total sperm count was measured. | Baseline, Month 3, Month 6, Follow-Up (Month 7) | 
| Semen Volume | Semen volume was measured. | Baseline, Month 3, Month 6, Follow-Up (Month 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Luteinizing Hormone (LH) Levels | LH levels were measured. | Baseline, Month 3, Month 6, Follow-Up (Month 7) | 
| Follicle Stimulating Hormone (FSH) Levels | FSH levels were measured. | Baseline, Month 3, Month 6, Follow-Up (Month 7) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH), Secondary hypogonadism, Semen volume, Sperm count, Sperm motility