Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone
Abstract
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).
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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