CCTN - COORDINATION OF CLINICAL TRIALS OF NESTORONE TESTOSTERONE GEL FOR MALE CONTRACEPTION

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The NICHD has a program to develop novel progestogenic androgenic hormonal drugs for male contraception. The purpose of this task order is to conduct work required and to provide the appropriate deliverables associated with clinical trials that are designed to evaluate progestogenic androgen drugs to determine safety and sperm suppressive activity leading to demonstration of contraceptive efficacy of this class of investigational products for men. The preliminary trials to determine first-in-man safety for the drugs have been completed. The next step is to conduct repeat dose gonadotropin suppressive activity and longer-term dosing to determine if the drugs will suppress sperm production To provide statistical and clinical coordination as well as monitoring of clinical trials, including services and support related to protocol development, logistical support, investigator meetings, data collection, database preparation, data analysis and preparation of clinical study reports of clinical trials of selected products for contraception in men.