Enclomiphene citrate stimulates testosterone production while preventing oligospermia A randomized phase II clinical trial comparing topical testosterone

Capsule:
Treatment with enclomiphene increases serum T, E2, and LH levels similar to those obtained with topical T gel in men with secondary hypogonadism with no lowering of sperm count.

Authors:
Ronald D. Wiehle, Ph.D., Gregory Fontenot, Ph.D., Jenny Wike, B.S., Kuang Hsu, M.S., Jennifer Nydell, B.S. Larry Lipshultz, M.D.

Volume 102, Issue 3, Pages 720-727

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).

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