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

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


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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Administration, Topical
  • Adult
  • Enclomiphene / therapeutic use*
  • Estradiol / blood
  • Humans
  • Hypogonadism / drug therapy*
  • Luteinizing Hormone / blood
  • Male
  • Middle Aged
  • Oligospermia / blood
  • Oligospermia / prevention & control*
  • Sex Hormone-Binding Globulin / analysis
  • Testosterone / administration & dosage*
  • Testosterone / analogs & derivatives
  • Testosterone / blood*
  • Up-Regulation / drug effects


  • Sex Hormone-Binding Globulin
  • Testosterone
  • Estradiol
  • boldenone
  • Luteinizing Hormone
  • Enclomiphene

Associated data

  • ClinicalTrials.gov/NCT01270841