Abstract: Clomiphene Citrate Safe for Long-Term Management of Hypogonadism

BJU Int. 2012 Mar 28. doi: 10.1111/j.1464-410X.2012.10968.x. [Epub ahead of print]

Clomiphene citrate is safe and effective for long-term management of hypogonadism.

Moskovic DJKatz DJAkhavan APark KMulhall JP.

Source: Sexual & Reproductive Medicine Program, Urology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

Abstract

Study Type – Therapy (population cohort) Level of Evidence 2a What’s known on the subject? and What does the study add? Clomiphene citrate(CC) has previously been documented to be efficacious in the treatment of hypogonadism. However little is known about the long term efficacy and safety of CC. Our study demonstrates that CC is efficacious after 3 years of therapy. Testosterone levels and bone mineral density measurement improved significantly and were sustained over this prolonged period. Subjective improvements were also demonstrated. No adverse events were reported.

OBJECTIVE: To assess the efficacy and safety of long-term clomiphene citrate (CC) therapy in symptomatic patients with hypogonadism (HG).

PATIENTS AND METHODS: Serum T, oestradiol and luteinizing hormone (LH) were measured in patients who were treated with CC for over 12 months. Additionally, bone densitometry (BD) results were collected for all patients. Demographic, comorbidity, treatment and Androgen Deficiency in Aging Men (ADAM) score data were also recorded. Comparison was made between baseline and post-treatment variables, and multivariable analysis was conducted to define predictors of successful response to CC. The main outcome measures were predictors of response and long-term results with long-term CC therapy in hypogonadal patients.

RESULTS: The 46 patients (mean age 44 years) had baseline serum testosterone (T) levels of 228 ng/dL. Follow-up T levels were 612 ng/dL at 1 year, 562 ng/dL at 2 years, and 582 ng/dL at 3 years (P < 0.001). Mean femoral neck and lumbar spine BD scores improved significantly. ADAM scores (and responses) fell from a baseline of 7 to a nadir of 3 after 1 year. •  No adverse events were reported by any patients.

CONCLUSIONS: Clomiphene citrate is an effective long-term therapy for HG in appropriate patients. The drug raises T levels substantially in addition to improving other manifestations of HG such as osteopenia/osteoporosis and ADAM symptoms.

© 2012 THE AUTHORS. BJU INTERNATIONAL © 2012 BJU INTERNATIONAL.

PMID: 22458540 [PubMed – as supplied by publisher]