Enclomiphene citrate stimulates testosterone production while p-eventing oligospermia: a randomized phase II clinical trial comparing topical testosterone.
Objective: To determine the effect of enclomiphene citrate in men with secondary hypogonadism.
Methods: iws randomized phase IIB study enrolled 124 men with a morning serum T level of <250 ng/dL on 2 occasions. e subjects were randomized to one of two doses of enclomiphene citrate (12.5-mg or 25-mg), 1% topical testosterone, or placebo. Hormone levels of LH, FSH, and T and semen level were measured before, during and after 3 months of treatment.
Results: A total of 113 men received 3 months of treatment, and 73 completed the study and provided both baseline and at least 1 semen sample at the end of the study. All 3 active treatment groups showed significantly increased in total testosterone level from baseline compared with placebo, with no statistically significant difference in testosterone levels found between the active treatment groups compared with placebo.