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Fertil Steril. 2014 Sep;102(3):720-7. doi: 10.1016/j.fertnstert.2014.06.004. Epub 2014 Jul 17.

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

Author information

1
Department of Urology, Repros Therapeutics Inc., Houston, Texas. Electronic address: rwiehle@reprosrx.com.
2
Department of Urology, Repros Therapeutics Inc., Houston, Texas.
3
Baylor College of Medicine, Houston, Texas.

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).

KEYWORDS:

Testosterone; hormones; male infertility; semen; testosterone replacement therapy

[Indexed for MEDLINE]

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