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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Androxal™ 12.5 mg |
|
| 2 | Experimental | Androxal™ 25 mg |
|
| 3 | Active Comparator | AndroGel® |
|
| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Androxal | Drug | 12.5 mg once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of Androxal™ administered in men with secondary hypogonadism | Six months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Additional inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Andre van As, MD, PhD | Repros Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | United States | ||
| Medical Affiliated Research Center, Inc. |
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| Androxal | Drug | 25 mg once daily |
|
|
| AndroGel | Drug | 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. |
|
| Placebo | Drug | 1 capsule daily |
|
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Northern California Research Corp. | Carmichael | California | 95608 | United States |
| Prime-Care Clinical Research | Mission Viejo | California | 92691 | United States |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Southeastern Research Group, Inc. | Tallahassee | Florida | 32308 | United States |
| Northeast Indiana Research, LLC | Fort Wayne | Indiana | 46825 | United States |
| Commonwealth Biomedical Research | Madisonville | Kentucky | 42431 | United States |
| The Center for Sexual Medicine at Sheppard Pratt | Baltimore | Maryland | 21285 | United States |
| Office of Keith Pierce, MD | Livonia | Michigan | 48152 | United States |
| Office of Michael Mall, MD | Las Vegas | Nevada | 89109 | United States |
| Office of Stephen Miller, MD | Las Vegas | Nevada | 89144 | United States |
| Advanced Biomedical Research, Inc. | Hackensack | New Jersey | 07601 | United States |
| Office of Gary S. Karlin | Lawrenceville | New Jersey | 08648 | United States |
| Medial Research Associates of Nashville | Nashville | Tennessee | 37203 | United States |
| Urology San Antonio Research, PA | San Antonio | Texas | 78229 | United States |
| Salt Lake Research | Salt Lake City | Utah | 84107 | United States |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D064695 | Enclomiphene |
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D002996 | Clomiphene |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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