Safety and pharmacokinetics of oral single-dose, 28 day repeat-dose, and dose escalation study of 11-MNTDC in healthy men have been conducted. The drug was well tolerated without serious adverse events. Daily oral dose of 11β-MNTDC for 28 days in healthy men showed markedly suppressed serum gonadotropins and T concentrations without serious adverse effects. NICHD is planning another Phase I trial to test 11β-MNTDC via intramuscular injection.
Researchers at the Eunice Kennedy Shriver National Institute of Child Health and Human Development are highly motivated in seeking licensing and/or collaboration partners for the development and use of androgenic compounds as contraceptives and/or hormonal therapeutics.