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This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo Gel and Placebo capsules |
|
| Androxal Treatment | Experimental | Androxal 12.5mg/25 mg and Placebo gel |
|
| AndroGel Treatment | Active Comparator | AndroGel 1.62% and Placebo Capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Androxal 12.5 mg/25 mg | Drug |
| ||
| Placebo Capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the proportion of subjects who meet the composite endpoint of normal 24-hour average testosterone and sperm concentration. | Comparison of the proportion of subjects whose 24-hour average testosterone levels are within the normal range [300-1,040 ng/dL] and whose sperm concentration is 15 million/mL or greater following 16 weeks of treatment with Androxal, placebo or AndroGel 1.62%. | 16 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with mean sperm concentration less than 15 million/mL after 16 weeks of treatment comparing Androxal to placebo in a non-inferiority assessment | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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|
| AndroGel 1.62% | Drug |
|
| Placebo Gel | Drug |
|
| Mobile |
| Alabama |
| United States |
| Evanston | Illinois | United States |
| Lexington | Kentucky | United States |
| Garden City | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Nashville | Tennessee | United States |
| Riverton | Utah | United States |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D064695 | Enclomiphene |
| ID | Term |
|---|---|
| D002996 | Clomiphene |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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