Abstract: PD68-09
Sources of Funding: None

Introduction

Infertility affects 15% of all couples in the United States (US) with up to half having a male etiology. There are currently no oral treatments of male infertility approved for use by the Food and Drug Administration. The selective estrogen receptor modulator Clomiphene is the most commonly prescribed such agent, however its usage is only described in case series. We sought to characterize the demographics and usage patterns of Clomiphene for male infertility across the United States.

Methods

This is a retrospective cohort study of individuals in the Truven Health MarketScan® claims database from 2001 to 2009. This US database provides information of insurance claims filed for the care of privately insured individuals with employment-based insurance. While the number of enrollees varies between years, recent years contained up to 30 million people. Pharmacy claims were used to identify the usage patterns of Clomiphene among male enrollees. Associated diagnoses and treatments were identified by utilizing International Classification of Diseases, 9th edition (ICD-9) and Current Procedural Terminology (CPT) codes. Rates of side effects previously reported for Clomiphene were compared 6 months before and 6 months after medication usage.

Results

3,922 men took Clomiphene and represented the primary study cohort, with a mean age of 35 years. Usage varied between 0.3% to 0.8%, with the highest prevalence among men 30-39 years old. No trend of usage was noted during the study period. Associated diagnoses of Clomiphene users included male infertility (59%), testicular hypofunction (32%), erectile dysfunction (8.6%), and low libido (0.6%). Infertility evaluation with semen analysis was performed in 55% of men. Testing for testosterone, LH, and FSH was done in 38%, 31%, and 35%. The median time of use was 2.4 months, with 73% of men stopping within 6 months, 17% stopping within the first year, and 3% continuing for more than 2 years. No increased risk of reported Clomiphene side effects (thrombotic events, vision problems, gynecomastia, mental disorders, liver disease, nausea, or skin problems) were apparent in men taking the medication.

Conclusions

The current report is the first to characterize the demographics and national usage patterns of Clomiphene, the most commonly prescribed oral agent for male infertility. Knowledge of adjuvant testing and prescribing practices for Clomiphene may inform and improve patient care. No increased risk of reported side effects was detected. Additional studies are needed to further understand indications, efficacy, and safety of Clomiphene use in men.

Funding

None