- Heather Gunas
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.
- Male contraceptive
- Treatment of hormonal diseases
- Significant market need for male contraceptive
- Clinical-stage asset
- No adverse events in a Phase I dose-escalation study
- Intramuscular (IM) injection
Richard Blye PhD, Hyun Kim
Nguyen, BT, et al. Acceptability of the oral hormonal male contraceptive prototype, 11β-methyl-19-nortestosterone dodecylcarbonate (11β-MNTDC), in a 28-day placebo-controlled trial [PMID 34153318]
Yuen, F, et al. Daily Oral Administration of the Novel Androgen 11β-MNTDC Markedly Suppresses Serum Gonadotropins in Healthy Men. [PMID 31976519]
Wu, S, et al. Safety and Pharmacokinetics of Single-Dose Novel Oral Androgen 11β-Methyl-19-Nortestosterone-17β-Dodecylcarbonate in Men. [PMID 30252057]
- U.S. Patent Issued: U.S. Patent Number 7,820,642, Issued 26 Oct 2010
- Hormonal Systems, Endocrine, and Metabolic Diseases