Enclomiphene citrate for the treatment of secondary male hypogonadism

ABSTRACT

Introduction: Hypogonadism is a growing concern in an aging male population. Historically treated using exogenous testosterone, concerns about possible adverse effects of testosterone have led physicians to seek alternative treatment approaches.

Areas covered: Enclomiphene citrate is the trans isomer of clomiphene citrate, a non-steroidal estrogen receptor antagonist that is FDA-approved for the treatment of ovarian dysfunction in women. Clomiphene citrate has also been used off-label for many years to treat secondary male hypogonadism, particularly in the setting of male infertility. Here we review the literature examining the efficacy and safety of enclomiphene citrate in the setting of androgen deficiency.

Expert opinion: Initial results support the conclusion that enclomiphene citrate increases serum testosterone levels by raising luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels, without negatively impacting semen parameters. The ability to treat testosterone deficiency in men while maintaining fertility supports a role for enclomiphene citrate in the treatment of men in whom testosterone therapy is not a suitable option.

KEYWORDS:

• Hypogonadism
• testosterone
• enclomiphene citrate
• selective estrogen receptor modulator

Declaration of interest

AW Pastuszak is a National Institutes of Health (NIH) K12 Scholar supported by a Male Reproductive Health Research Career (MHRH) Development Physician-Scientist Award (Grant Number: HD073917-01) from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Program. LI Lipshultz is a speaker for American Medical Systems and Repros Therapeutics, he is a clinical investigator for Endo Pharmaceuticals and Repros Therapeutics and he is a consultant for American Medical Systems, Endo Pharmaceuticals, Repros Therapeutics, AbbVie and Lipocine. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This work was supported by the National Institute of Child Health and Human Development: [Grant Number HD073917-01].