Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone
Ronald D Wiehle, Gregory K Fontenot, Jenny Wike, Kuang Hsu, Jennifer Nydell, Larry Lipshultz, ZA-203 Clinical Study Group, Bruce Gilbert, Jed Kaminetsky, William Koltun, Michael Mall, Stephen Miller, David Mobley, Ronald Swerdloff, Michael Werner, Harvey Resnick, Natan Bar-Chama, Douglas Young, Michael Minh Dao, Berg Cetero, Kenneth Goldberg, Robert Strzinek, Rakesh Patel, Ronald D Wiehle, Gregory K Fontenot, Jenny Wike, Kuang Hsu, Jennifer Nydell, Larry Lipshultz, ZA-203 Clinical Study Group, Bruce Gilbert, Jed Kaminetsky, William Koltun, Michael Mall, Stephen Miller, David Mobley, Ronald Swerdloff, Michael Werner, Harvey Resnick, Natan Bar-Chama, Douglas Young, Michael Minh Dao, Berg Cetero, Kenneth Goldberg, Robert Strzinek, Rakesh Patel
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.
Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
Source: PubMed