drugset / Trial / NCT01382069
Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men
Phase 1
Completed
100 enrolled
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
National Institutes of Health (NIH) · collabUniversity of Washington · collab
RandomizedSingle-groupQuadruple-blindTreatment
Summary
The long term objective is to develop a new male hormone Dimethandrolone Undecanoate (DMAU) as a male hormonal contraceptive. The study has two parts. The first is a dose escalating study in healthy to assess the safety and tolerability of single dose oral administration of DMAUin healthy men.(Completed) The second is to study the safety and tolerability of DMAU after 28 days of repeated daily dosing of DMAU in healthy men. (Currently Recruiting) In both parts the investigators will also study the pharmacokinetics of Dimethandrolone (DMA) in the serum after oral administration of DMAU.
Timeline
- Start
- 2012-03
- Primary completion
- 2017-02
- Completion
- 2017-05
Publications
- Background Attardi BJ, Hild SA, Reel JR. Dimethandrolone undecanoate: a new potent orally active androgen with progestational activity. Endocrinology. 2006 Jun;147(6):3016-26. doi: 10.1210/en.2005-1524. Epub 2006 Feb 23.
- Background Attardi BJ, Engbring JA, Gropp D, Hild SA. Development of dimethandrolone 17beta-undecanoate (DMAU) as an oral male hormonal contraceptive: induction of infertility and recovery of fertility in adult male rabbits. J Androl. 2011 Sep-Oct;32(5):530-40. doi: 10.2164/jandrol.110.011817. Epub 2010 Dec 16.
- Background Attardi BJ, Marck BT, Matsumoto AM, Koduri S, Hild SA. Long-term effects of dimethandrolone 17beta-undecanoate and 11beta-methyl-19-nortestosterone 17beta-dodecylcarbonate on body composition, bone mineral density, serum gonadotropins, and androgenic/anabolic activity in castrated male rats. J Androl. 2011 Mar-Apr;32(2):183-92. doi: 10.2164/jandrol.110.010371. Epub 2010 Aug 26.
- Yuen F, Thirumalai A, Fernando FA, Swerdloff RS, Liu PY, Pak Y, Hull L, Bross R, Blithe DL, Long JE, Page ST, Wang C. Comparison of metabolic effects of the progestational androgens dimethandrolone undecanoate and 11beta-MNTDC in healthy men. Andrology. 2021 Sep;9(5):1526-1539. doi: 10.1111/andr.13025. Epub 2021 May 22.
- Thirumalai A, Yuen F, Amory JK, Hoofnagle AN, Swerdloff RS, Liu PY, Long JE, Blithe DL, Wang C, Page ST. Dimethandrolone Undecanoate, a Novel, Nonaromatizable Androgen, Increases P1NP in Healthy Men Over 28 Days. J Clin Endocrinol Metab. 2021 Jan 1;106(1):e171-e181. doi: 10.1210/clinem/dgaa761.
- Thirumalai A, Ceponis J, Amory JK, Swerdloff R, Surampudi V, Liu PY, Bremner WJ, Harvey E, Blithe DL, Lee MS, Hull L, Wang C, Page ST. Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men: A Prototype Male Pill. J Clin Endocrinol Metab. 2019 Feb 1;104(2):423-432. doi: 10.1210/jc.2018-01452.
- Ayoub R, Page ST, Swerdloff RS, Liu PY, Amory JK, Leung A, Hull L, Blithe D, Christy A, Chao JH, Bremner WJ, Wang C. 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 Mar;5(2):278-285. doi: 10.1111/andr.12303. Epub 2016 Dec 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dimethandrolone Undecanoate | Unknown | 100 mg | Oral |
| Subject | Dimethandrolone Undecanoate | Unknown | 200 mg | Oral |
| Subject | Dimethandrolone Undecanoate | Unknown | 400 mg | Oral |
Indications
No indication recorded.