11b-MNTDC / 11β/19/17β
11b-methyl-19-nortestosterone 17b-dodecylcarbonate (11b-MNTDC)
- User: Male
- Hormonal: Hormonal
-
Delivery type:
- Multiple
- Injectable
- Oral
-
Intended Duration:
- Short-Acting
- Development Stage: Phase I
- Developer(s)/researcher(s): BIOQUAL, Inc, NICHD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Washington, Health Decisions
Details
- API: 11b-methyl-19-nortestosterone 17b-dodecylcarbonate
- Target: Progesterone Receptor, Androgen Receptor
-
Mechanism of Action:
- Reduced Sperm Production
- Inhibition of Sperm Capacitation
- Inactive Materials: Not Yet Determined
- Regimen: 1 Pill/Day
- MPT: Not Potential MPT
- Promising Attributes: Some evidence suggests male user interest in oral contraceptives. 11β-MNTDC is understood to be less hepatotoxic than other candidates for daily oral male contraceptives.
Product Status
Active/Recent Clinical Development
History
2010: In vivo and in vitro evaluation of 11β-methyl-19-nortestosterone determines that inhibition of 5a-reductase activity would likely not affect the molecule's androgenic potency. Rabbit studies suggest that a prodrug of 11β-methyl-19-nortestosterone, 11β-MNTDC, was the least toxic to the liver of a number of evaluated synthetic androgens.
2011: Continued animal studies suggest that 11β-MNTDC use results in comparable body changes to testosterone use
2019: First clinical results, from a Phase I study, conclude that the prodrug is safe and well tolerated, but shows minimal receptor binding activity
2020: Phase I study results suggest the prodrug can suppress gonadotropins, testosterone, estradiol, and SHBG and should be further evaluated.
2022: NICHD researchers present Phase I study results at the 2022 Endocrine Society annual meeting
2024: NICHD provides supplemental Task Order to Health Decisions for coordination of the Contraceptive Development Program. Task Order references 11-beta-MNTDC as an active development platform under the CDP.