Dimethandrolone undecanoate or DMAU releases a combination of androgen and progesterone receptors to form an agent that inhibits the production of gonadotropins and new sperm cells while maintaining androgenic activity. It is to be taken once a day.
'Many men said they would prefer a daily pill as a reversible contraceptive, rather than long-acting injections or topical gels, which are also in development'. This means at least twice daily pills are recommended.
Dr Page said longer term studies are now underway to confirm that when taken every day, DMAU blocks sperm production. Early trials show the pill to be both safe and effective. The study was conducted at the University of Washington Medical Center and at Harbor-UCLA Medical Center in Torrance, CA with assistance from Christina Wang, MD, professor of medicine at the University of California, Los Angeles and Arthi Thirumalai, MD, Assistant professor of medicine at the University of Washington.
The investigators tested three different doses of DMAU - 100, 200, and 400 milligrams, or mg. Out of each group, five subjects were given a placebo while another 12-15 were given daily doses of DMAU for 28 days.
A total of 83 men completed the study, including giving blood samples for hormone and cholesterol testing on the first and last day of the study. This had been done once at baseline as well. Men who were on the highest dose of the pill - 400 mg - showed "marked suppression" of levels of their testosterone and two hormones required for sperm production. This led to effective contraception.
Although there were no significant changes in mood, sexual function, vital signs, or electrocardiogram, men taking DMAU did experience mild weight gain, decreased higher-density lipoprotein cholesterol, and increased hematocrit compared with men receiving placebo.
Despite having low levels of circulating testosterone, very few subjects reported symptoms consistent with testosterone deficiency or excess.
The low levels, Page said, were consistent with effective male contraception shown in longer-term studies. All participants passed safety tests including liver and kidney health checks.
"These promising results are unprecedented in the development of a prototype male pill", Page said.