NCT01382069 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
Attardi BJ, Hild SA, Reel JR
Dimethandrolone undecanoate: a new potent orally active androgen with progestational activity. Endocrinology. 2006 Jun;147(6):3016-26. Epub 2006 Feb 23.
Attardi BJ, Marck BT, Matsumoto AM, Koduri S, Hild SA
Long-term effects of dimethandrolone 17ß-undecanoate and 11ß-methyl-19-nortestosterone 17ß-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.

Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men

Details for clinical trial NCT01382069

Clinical trial NCT01382069 - References