biostudies-literatureBunin DIHHSNICHD NIH HHSU.S. Department of Health and Human ServicesNational Institutes of Health (NIH)Oregon National Primate Research Center, Oregon Health & Science UniversityNIH HHSDivision of Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)1919-1934https://www.ebi.ac.uk/biostudies/studies/S-EPMC12145459biostudies-literatureUnknown13(7)<h4>Background</h4>Dimethandrolone undecanoate (DMAU) is under development as a single agent hormonal male contraceptive. DMAU is a prodrug hydrolyzed by esterase(s) to the active metabolite dimethandrolone (DMA) which has dual androgenic and progestogenic actions. Phase 1 clinical trial results show DMAU to be well-tolerated as an oral contraceptive in healthy men; however, delivery of DMAU as a long-acting injectable rather than a daily oral formulation would provide user compliance benefits and address oral bioavailability concerns.<h4>Objective</h4>To assess the safety, pharmacokinetics (PK), and long-acting contraceptive potential of DMAU in male non-human primates (NHP) when delivered as an injectable or oral formulation.<h4>Materials and methods</h4>DMAU was administered to cynomolgAndrologyEvaluation of dimethandrolone undecanoate in non-human primates as a candidate for long-acting injectable male contraceptive.PMC12145459P51OD011092HHSN275201500002CHHSN275201500002IP51 OD01109275N94020D00003Bunin DIAdevai TGahagen JZelinski MBTang LIyer LLee MSWang CKim KEndsley AParman TBlithe DLfalseEvaluation of dimethandrolone undecanoate in non-human primates as a candidate for long-acting injectable male contraceptive.<h4>Background</h4>Dimethandrolone undecanoate (DMAU) is under development as a single agent hormonal male contraceptive. DMAU is a prodrug hydrolyzed by esterase(s) to the active metabolite dimethandrolone (DMA) which has dual androgenic and progestogenic actions. Phase 1 clinical trial results show DMAU to be well-tolerated as an oral contraceptive in healthy men; however, delivery of DMAU as a long-acting injectable rather than a daily oral formulation would provide user compliance benefits and address oral bioavailability concerns.<h4>Objective</h4>To assess the safety, pharmacokinetics (PK), and long-acting contraceptive potential of DMAU in male non-human primates (NHP) when delivered as an injectable or oral formulation.<h4>Materials and methods</h4>DMAU was administered to cynomolg2025-01-01T00:00:00Z2025 Oct2026-07-15T12:33:54.721Z2026-07-04T03:13:00.967ZS-EPMC121454593964859010.1111/andr.13819