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The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Androxal | Experimental | Androxal (enclomiphene citrate)12.5 mg or 25 mg |
|
| Testim (topical testosterone) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Androxal (enclomiphene citrate) | Drug | capsules oral 1x a day 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in testosterone comparing Androxal to Testim | Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) | Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim | 1 year |
| Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Garden Grove | California | 92844 | United States | |||
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| Label | URL |
|---|---|
| Sponsor website | View source |
| Study information | View source |
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| Testim (topical testosterone) | Drug | topical 1 tube 1x a day 1 year |
|
|
Reproductive safety will be assessed by changes in values from baseline of semen volume, and sperm concentration, total count, morphology and motility at baseline (Visit 1), month 4, 6 and 12 comparing Androxal 12.5 and 25 mg to Testim |
| 1 year |
| Sacramento |
| California |
| 95821 |
| United States |
| San Diego | California | 92108 | United States |
| Las Vegas | Nevada | 89109 | United States |
| Las Vegas | Nevada | 89144 | United States |
| Houston | Texas | 77024 | United States |
| Houston | Texas | 77062 | United States |
| Houston | Texas | 77095 | 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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