Objective: To determine the effect of enclomiphene citrate in men with secondary hypogonadism.
Design: Phase II clinical trial.
Setting: Community dwelling men making visits to physician offices.
Patient(s): Men with secondary hypogonadism.
Intervention(s): Oral administration of enclomiphene citrate or 1% topical T gel.
Main Outcome Measure(s): Luteinizing hormone, FSH, T, and semen analysis.
Result(s): Treatment with enclomiphene citrate resulted in increased morning serum T, E2, and LH levels similar to those obtained with a topical T gel in men with secondary hypogonadism. Follicle-stimulating hormone and LH were increased with enclomiphene, and sperm counts were conserved.
Conclusion(s): Enclomiphene citrate reverses the two hallmarks of secondary hypogonadism, namely, low serum total T and low or inappropriately normal LH while preserving sperm production.
Clinical Trial Registration Number: NCT01270841 (ClinicalTrials.gov Identifier NCT01270841).
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