CCTN - CONTRACEPTIVE CLINICAL TRIALS - MALE SITES, DMAU

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Male Contraceptive Trial DMAU with Self-Emulsifying Drug Delivery System (SEDDS) This Task Order is for the conduct of a Phase I clinical trial to test whether Dimethand.rolone undecanoate will be well tolerated and will suppress gonadotropins. Preliminary results from animal studies indicate that an oral dose of the drug has both progestin and androgen activity and will suppress gonadotropins sufficiently to a level that produces inhibition of spermatogenesis. Since this study is first in man, it is not known what dose of drug will be effective at suppression of gonadotropins or if the drug will be well tolerated. The study will test a single dose of drug in men and will continue with single doses of escalating strength assuming that the drug is well tolerated. The primary outcome will be to measure suppression of gonadotropins over the treatment period and to collect information about possible side effects.