By Rebecca Bowers

EXECUTIVE SUMMARY

Researchers at the University of Washington and Harbor-University of California, Los Angeles Medical Center are evaluating the use of a daily contraceptive pill containing dimethandrolone undecanoate for men.

  • In a small study, the drug lowered hormones to a degree that should prove effective as a contraceptive, researchers say.
  • Men currently have two options available when it comes to contraception — the male condom or vasectomy. Survey data on men across different countries, ethnicities, and socioeconomic groups show that men and couples are very interested in men taking responsibility for birth control.

Researchers at the University of Washington and Harbor-University of California, Los Angeles Medical Center are evaluating the use of a daily contraceptive pill containing dimethandrolone undecanoate pill for men. Results presented at the 2018 Endocrine Society Annual Meeting in Chicago indicated that the experimental male birth control pill was safe when given for 28 days.1

The current study, which included 83 men between the ages of 18-50 years, showed that the study drug lowered hormones to a degree that should prove effective as a contraceptive. Scientists now plan to conduct studies to demonstrate sperm suppression. The researchers will be testing dimethandrolone undecanoate on 100 men over a three-month period.

Dimethandrolone undecanoate represents an advance in the development of a once-daily “male pill,” says senior investigator Stephanie Page, MD, PhD, professor of medicine at the University of Washington.

“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,” noted Page in a press statement.

Search Continues for Effective Option

The road to developing a male oral contraceptive has been hindered by the fact that available oral forms of testosterone may cause liver inflammation, noted Page.2 Oral forms of testosterone also clear the body too quickly for once-daily dosing, she explained. The chemical structure of dimethandrolone undecanoate contains a long-chain fatty acid, which slows such clearance, said Page. The drug is being developed for possible contraceptive use by the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, which funded the current study.

To conduct the study, researchers enrolled 100 healthy men at the University of Washington Medical Center and at Harbor-UCLA Medical Center. Scientists used three different doses of dimethandrolone undecanoate (100 mg, 200 mg, and 400 mg) and two different formulations (castor oil and powder) inside the capsules. The study design called for each dose group to include five subjects, who were assigned randomly to receive an inactive placebo, and another 12-15 men who received the study drug. Subjects took the drug or placebo for 28 days once daily with food, since dimethandrolone undecanoate must be taken with food to be effective.

Eighty-three men completed the study; researchers obtained blood samples for hormone and cholesterol testing on the first and last days of the trial. Results indicate that those who used 400 mg pills (the highest dose of study drug tested) exhibited marked suppression of testosterone levels and of two hormones required for sperm production. Such levels are consistent with effective male contraception shown in longer-term studies, researchers state.

All men who used the study drug exhibited mild weight gain and decreases in HDL cholesterol. All study participants passed safety tests, including markers of liver and kidney function.1

Moving Forward in Research

Providing men with a practical and reversible contraceptive option is “long overdue,” says co-investigator Christina Wang, MD, professor of medicine and assistant dean in clinical and translational sciences at the David Geffen School of Medicine at UCLA. Wang also serves as the associate director of the UCLA Clinical and Translational Science Institute, and as a faculty member of the Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute.

“Sixty years after the pill was developed for women, men will now have options that neither require surgery nor long-acting injections to participate in family planning as equal partners,” noted Wang in a press statement.

Men currently have two options available when it comes to contraception the male condom or vasectomy. Survey data on men across different countries, ethnicities, and socioeconomic groups show that men and couples are very interested in men taking responsibility for birth control.3

“It is unfair to discredit a whole gender as not being trustworthy enough to take that responsibility, when they are specifically telling us otherwise,” says Arthi Thirumalai, MD, co-investigator and acting assistant professor in Metabolism, Endocrinology and Nutrition at the University of Washington. “When men have more options, we will have real world data as to their interest and engagement.” 

REFERENCES

  1. Thirumalai A, Ceponis J, Amory JK, et al. Pharmacokinetic and pharmacodynamic effects of 28 days of oral dimethandrolone undecanoate in healthy men: A prototype male pill. Presented at ENDO 2018: The Endocrine Society Annual Meeting. Chicago; March 2018.
  2. Bassil N, Alkaade S, Morley JE. The benefits and risks of testosterone replacement therapy: A review. Ther Clin Risk Manag 2009;5:427-448.
  3. Wang C, Festin MP, Swerdloff RS. Male hormonal contraception: Where are we now? Curr Obstet Gynecol Rep 2016;5:38-47.