FRI442 Ongoing Clomiphene Treatment For Men With Hypogonadotropic Hypogonadism

Disclosure: S.R. Smith: None. Context: Male hypogonadism is becoming recognized with increasing frequency. Testosterone products remain the only approved medical therapy, although highly problematic in men with hypogonadotropic hypogonadism because of inconvenient routes of administration, high cost, and unavoidable suppression of the hypothalamic-pituitary-gonadal axis. There is a need for effective and safe alternative medication. Objective: The purpose of this study was to evaluate the use of clomiphene long term in men with hypogonadotropic hypogonadism. Methods: Thirty-one men with non-congenital hypogonadotropic hypogonadism were treated with clomiphene citrate on an ongoing basis for up to 20 years. Seven patients were treated for > 12 years; 20 patients were treated for > 4 years. Initial age range was from 23 to 74 years, with a mean of 52. Serum testosterone and LH levels were monitored periodically. Clomiphene dose was adjusted at each office visit as required to achieve and maintain normal testosterone levels and improvement in hypogonadal symptoms in each individual patient. Patients were monitored for adverse effects. Data generated were analyzed retrospectively with Microsoft Excel statistical programs. Results: Improvement in hypogonadal symptoms occurred in nearly all patients. All 31 men experienced increases in serum testosterone and LH levels into the normal range, and statistical analysis showed these increases to be highly significant. Testosterone levels increased from 226 +/- 12 to 542 +/- 35 (mean +/- SEM) ng/dl through the period of treatment (P < .0001). LH levels increased from 3.6 +/- 0.4 to 10.0 +/- 1.6 mIU/ml (P < .0002). Clomiphene dose required to achieve and maintain appropriate responses was highly variable within the group of patients, ranging from 3.57 to 200 mg daily, with a mean dose of 54.4 mg daily. There was evidence of diminishing returns with dosage increases to > 100 mg daily. However, response to adjusted clomiphene dose, once established, was generally quite stable for each patient over extended periods of time, up to 20 years. No major adverse effects were encountered. Conclusions: Clomiphene is an effective and safe long-term treatment for men with non-congenital hypogonadotropic hypogonadism. It should be made available as an alternative to testosterone products for this group of men. Presentation: Friday, June 16, 2023