New male birth control pill safe, effective: Study

Washington, March 19: In a major step towards developing a once- daily ‘ male pill’, a new birth control drug has been found to be safe and effective in men, scientists say.

Like the pill for women, the experimental male oral contraceptive — called dimethandrolone undecanoate, or DMAU — combines activity of an androgen ( male hormone) like testosterone, and a progestin, said Stephanie Page, a professor at the University of Washington in the US.

“DMAU is a major step forward in the development of a once- daily ‘ male pill’,” said Page, senior investigator of the study presented at the Endocrine Society’s annual meeting in Chicago.

“Many men say they would prefer a daily pill as a reversible contraceptive, rather than long- acting injections or topical gels, which are also in development,” she said.

Progress toward a male birth control pill has been stymied because available oral forms of testosterone may cause liver inflammation, and they clear the body too quickly for oncedaily dosing, thus requiring two doses a day.

However, DMAU contains undecanoate, a longchain fatty acid, which Page said slows this clearance.

DMAU is being developed by the US National Institutes of Health, and Eunice Kennedy Shriver National Institute of Child Health and Human Development.

The study included 100 healthy men, aged 18 to 50 years.

The researchers tested three different doses of DMAU ( 100, 200, and 400

milligrammes, or mg) and two different formulations inside the capsules ( castor oil and powder).

Each dose group included five subjects who were randomly assigned to receive an inactive placebo and another 12 to 15 men who received DMAU.

Subjects took the drug or placebo for 28 days once daily with food. DMAU must be taken with food to be effective, Page noted.

At the highest dose of DMAU tested, 400 mg, subjects showed “marked suppression” of levels of their testosterone and two hormones required for sperm production.

The low levels, Page said, are consistent with effective male contraception shown in longer- term studies.

“Despite having low levels of circulating testosterone, very few subjects reported symptoms consistent with testosterone deficiency or excess,” Page said.

“These promising results are unprecedented in the development of a prototype male pill,” she added.

◗ Like the pill for women, the experimental male oral contraceptive combines activity of an androgen ( male hormone) like testosterone, and a progestin. Progress toward a male birth control pill has been stymied because available oral forms of testosterone may cause liver inflammation.