A new birth control pill for men with a hormonal component has shown efficacy and safety in preventing pregnancies when used once daily for a month. The study was presented yesterday (18th of March 2018) at the ENDO 2018, the Endocrine Society's 100th annual meeting in Chicago, Illinois.
The study with the new pill was tested on 83 men. It contains dimethandrolone undecanoate, or DMAU. The pill contains the activities of male hormone testosterone and also a female hormone progestin. It is to be taken once a day. DMAU is developed by the National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, that also sponsored this study.
Stephanie Page, M.D., PhD, professor of medicine at the University of Washington, Seattle, Washington led the study. She explained that many men would opt for a once daily pill that provides them with reversible contraception rather than go in for topical gels or long acting injections of DMAU that would provide longer term contraception. She explained that testosterone preparations till date have not shown success as male contraceptives because they can lead to liver inflammation. These testosterone pills are also cleared easily and rapidly from the body. This means at least twice daily pills are recommended. DMAU on the other hand contains undecanoate, a long-chain fatty acid that delays its exit from the body and allows for a single daily dose. The pills need to be taken with food to be effective, she said.
The study started off with 100 men of whom 83 completed the study. The men were aged between 18 and 50 and were all healthy. 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 participants were given three different doses of DMAU - 100, 200, and 400 mg. they were given two different formulations inside the capsules - one with powder and one with castor oil/ benzyl benzoate. Five persons in each group received a placebo and 12 to 15 men received the DMAU pills. The pills were taken for 28 days once daily with food.
At the end of the study the 83 men gave their blood samples for testing hormone levels as well as cholesterol levels. This had been done once at baseline as well. Results showed at men who were given 400mg of DMAU showed marked suppression of their testosterone levels. This led to effective contraception. Page explained that although the blood levels of the male hormones dipped, there were no symptoms of testosterone deficiency or excess. These men however gained weight slightly, developed mild acne and showed mild decrease in HDL cholesterol. Their liver functions and kidney functions were however normal and the drug was deemed safe. There were no changes in the EKG results or vital signs with this drug use. Mood and sexual functions too remained unaltered with this pill, Page said. She added that this study paves the way for further longer term studies with larger populations of men to prove that taking DMAU each day regularly can block the production of sperm and provide contraception.