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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 the 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Androxal Placebo and Gel Placebo |
|
| AndroGel Treatment | Active Comparator | AndroGel 1.62% and Placebo Capsules |
|
| Androxal Treatment | Experimental | Androxal 12.5 mg or 25mg and Placebo Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Androxal 12.5 mg or 25 mg | Drug |
| ||
| AndroGel 1.62% |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the proportion of subjects meeting the composite endpoint for normal morning testosterone and semen concentration. | Comparison of the proportion of subjects whose morning 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 |
|---|---|---|---|---|---|---|
| Jacksonville | Florida | United States | ||||
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|
| Placebo Capsules | Drug |
|
| Placebo Gel | Drug |
|
| Albany |
| New York |
| United States |
| Raleigh | North Carolina | United States |
| Cleveland | Ohio | United States |
| Medford | Oregon | United States |
| Warwick | Rhode Island | United States |
| Houston | Texas | United States |
| Webster | Texas | 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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