A Phase 2 interventional study of Clomiphene in Hypogonadism, Male, sponsored by Phoenix VA Health Care System. Completed at 1 site in United States. Open to male participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-10.
Sponsored by Phoenix VA Health Care System · Phase 2, Interventional, and Treatment
This study aims to explore whether men with low testosterone levels, due to altered brain regulation of male hormone function, who have been previously treated with testosterone, respond as well as men who have not been so treated to clomiphene citrate, an agent commonly used for female infertility that has been shown to improve male hormone secretion in some cases.
Clomiphene, an oral FDA-approved agent for female infertility has been shown to normalize testosterone levels in men with hypogonadotropic hypogonadism. It appears to be safe and well tolerated. This study will compare testosterone responses to clomiphene citrate in male veterans with hypothalamic hypogonadism naïve to treatment with responses of similar patients already receiving treatment with injectable or transdermal testosterone. This is an open-label, prospective, interventional trial to be conducted in an outpatient specialty care setting. We will randomize 64 hypogonadal male veterans evenly divided between naive and previous treatment and treat for 8 weeks with clomid, increasing the initial dose of 25 mg to 50 mg/day in those who fail to achieve target testosterone level (450 ng/dl) after the first 3 weeks. Endpoint measurements performed in the Phoenix VA Health Care System (PVAHCS) clinical laboratory will be total testosterone as well as bioavailable testosterone and sex hormone binding globulin. Total testosterone level at 8 weeks of treatment will be reported as the primary endpoint. Safety measures (CBC,liver functions, PSA) will be assessed at 8 weeks as well. This study will help serve as a guide for design of future studies of clomiphene in hypogonadal men.
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's enrollment of 42 is below the median of 60 across 55 interventional studies indexed under Eunuchism.
Browse Eunuchism studies →Phoenix VA Health Care System is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Clomiphene
Drug: Clomiphene
Clomiphene
Drug: Clomiphene
Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks
Also known as: Clomid, Clomiphene citrate
Total serum testosterone
laboratory measurement by standard immunometric method
Time frame: at the end of 8 weeks of treatment
Bioavailable testosterone
Non-SHBG bound testosterone by ammonium sulfate precipitation method
Time frame: at the end of 8 weeks of treatment
Serum sex hormone binding globulin (SHBG)level
Laboratory measurement of SHBG by standard immunometric technique
Time frame: at the end of 8 weeks of treatment
The record gives a start of Oct 2012, a primary completion of Oct 2018 and a completion of Oct 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clomiphene
Phoenix VA Health Care System