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

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.