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

• Published in: Fertility and sterility Vol. 102; no. 3; pp. 720 - 727
• Main Authors: Wiehle, Ronald D., Ph.D, Fontenot, Gregory K., Ph.D, Wike, Jenny, B.S, Hsu, Kuang, M.S, Nydell, Jennifer, B.S, Lipshultz, Larry, M.D
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-09-2014
• Subjects: Administration, Oral; Administration, Topical; Adult; Enclomiphene - therapeutic use; Estradiol - blood; hormones; Humans; Hypogonadism - drug therapy; Internal Medicine; Luteinizing Hormone - blood; Male; male infertility; Middle Aged; Obstetrics and Gynecology; Oligospermia - blood; Oligospermia - prevention & control; semen; Sex Hormone-Binding Globulin - analysis; Testosterone; Testosterone - administration & dosage; Testosterone - analogs & derivatives; Testosterone - blood; testosterone replacement therapy; Up-Regulation - drug effects; semen; Testosterone; hormones; male infertility; testosterone replacement therapy
• ISSN: 0015-0282; 1556-5653
• DOI: 10.1016/j.fertnstert.2014.06.004

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 ).