A Phase 3 interventional study of Androxal and Androxal in Secondary Hypogonadism, sponsored by Repros Therapeutics Inc.. Completed at 18 sites in United States. Open to male participants aged 18 Years to 68 Years. Per ClinicalTrials.gov, last updated 2010-02-11.
Sponsored by Repros Therapeutics Inc. · Phase 3, Interventional, and Treatment
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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This study's enrollment of 194 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Repros Therapeutics Inc. is the lead sponsor of 57 studies on the registry; none are open to participants now.
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Androxal™ 12.5 mg
Drug: Androxal
Androxal™ 25 mg
Drug: Androxal
AndroGel®
Drug: AndroGel
Placebo
Drug: Placebo
12.5 mg once daily
Also known as: Enclomiphene citrate
25 mg once daily
Also known as: Enclomiphene citrate
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.
1 capsule daily
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism
Time frame: Six months
Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel®
Time frame: Six months
This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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Repros Therapeutics Inc.