Dimethandrolone undecanoate — DMAU — is a potential oral male contraceptive, and the early work compared the single-dose pharmacokinetics, pharmacodynamics and safety of two novel oral formulations of it.[1]
The design intent is legible from the name. Undecanoate is the same long ester used to make injectable testosterone last for months; here it is doing a different job — helping an androgen survive oral administration. DMAU was built specifically against the obstacle that stopped the injectable programmes.
Why an oral candidate mattered so much
The 1990s trials showed hormonal suppression could deliver contraceptive efficacy.[2] What they could not deliver was a product healthy young men would use, because the regimen was a weekly intramuscular injection.
Solving that means solving the oldest problem in testosterone pharmacology: given orally, testosterone is inactivated in the liver, so parenteral routes or molecular modifications are required.[3] The modification route historically produced 17-alpha-alkylated androgens that survive first-pass metabolism and cause hepatotoxicity.[4]
DMAU is an attempt at the modification route without that penalty.
What "phase 1" actually establishes
Worth being precise, because early-phase results get reported as breakthroughs.
The study compared single-dose pharmacokinetics, pharmacodynamics and safety across two oral formulations.[1] That answers: is the compound absorbed, does it do what it should to the relevant hormonal markers, and is it tolerated acutely?
It does not answer: does it prevent pregnancy, at what rate, over what duration, with what side-effect profile over years of use, and is suppression reversible. Those require the trials that come after.
Why it is still not on a shelf
The bar for a contraceptive given to healthy people is high, and the requirements compound: near-total suppression, in nearly everyone, reversibly, with side effects acceptable to someone who is not ill, over years.
Each stage of development tests one more of those, and each is a place to fail. The systematic evidence on the hormonal approach as a class is in the Cochrane review of steroid hormones for contraception in men.[2] Nothing in it has yet produced a marketed product.
Frequently asked questions
Is DMAU available? No. The work cited here is early-phase pharmacokinetic, pharmacodynamic and safety comparison.[1]
Does it work as a contraceptive? Contraceptive efficacy is a later-phase question that a single-dose study does not address.[1]
Is it safe? Acute tolerability in early-phase work is not the same as long-term safety in healthy users.
Why does a contraceptive contain an androgen? Because suppressing the axis removes the body's own testosterone, so the drug has to replace it. See why male contraception is hard.
Next in this series
If a pill is hard, a daily gel is the other way to solve delivery — and that one reached an international efficacy trial.
Continue with the NES/T gel.
References
4 sources
- Ayoub R, Page ST, Swerdloff RS, et al. Comparison of the single dose pharmacokinetics, pharmacodynamics, and safety of two novel oral formulations of dimethandrolone undecanoate (DMAU): a potential oral, male contraceptive. Andrology. 2017;5(2):278–285. doi:10.1111/andr.12303 · PMID 27907978
- Grimes DA, Lopez LM, Gallo MF, et al. Steroid hormones for contraception in men. Cochrane Database Syst Rev. 2012;2012(3):CD004316. doi:10.1002/14651858.CD004316.pub4 · PMID 22419294
- Nieschlag E, Nieschlag S. ENDOCRINE HISTORY: The history of discovery, synthesis and development of testosterone for clinical use. Eur J Endocrinol. 2019;180(6):R201–R212. doi:10.1530/EJE-19-0071 · PMID 30959485
- Jockenhövel F. Testosterone supplementation: what and how to give. Aging Male. 2003;6(3):200–206. PMID 14628500
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