The birth control pill has been available
to women for a long time since FDA-approved it in 1960 but an
oral contraceptive for men has not yet hit the market.Scientists are in look
out for a male birth control pill which is as effective and acceptable like
female birth control pill. But progress toward a male birth control pill has
been stymied because available oral forms of testosterone cause liver
inflammation and clear the body too quickly for once-daily dosing, thus requiring
two doses a day.Stephanie Page, professor of medicine at the University
of Washington, Seattle, Wash, and colleagues have conducted a study and found
out a new birth control pill for men that appears to be safe when used
daily for a month with hormone responses consistent with effective
contraception. The results of the study have been presented at ENDO 2018, the
Endocrine Society’s 100th annual meeting in Chicago, Ill.
According to researchers the experimental male
oral contraceptive–called dimethandrolone undecanoate, or DMAU–combines
activity of an androgen (male hormone) like testosterone, and a progestin, and
is taken once a day like a pill for women. DMAU contains undecanoate, a
long-chain fatty acid which slows this clearance required for once a day
dose and is being developed by the National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child Health and Human Development.”DMAU
is a major step forward in the development of a once-daily ‘male pill’,” Page
said. “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.”
The study included 100 healthy men, ages 18 to 50
years, and took place at the University of Washington Medical Center and at
Harbor-UCLA Medical Center in Torrance, CA (led by co-author Christina Wang,
M.D.). The investigators tested three different doses of DMAU (100, 200, and
400 milligrams, 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.
A total of 83 men completed the study, including
giving blood samples, for hormone and cholesterol testing, on the first and
last days of the study.
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.
All groups taking DMAU did have weight gain and
decreases in HDL (“good”) cholesterol, both of which Page said were mild. All
subjects passed safety tests, including markers of liver and kidney function.
“These promising results are unprecedented in the
development of a prototype male pill,” Page said. “Longer term studies are
currently under way to confirm that DMAU taken every day blocks sperm
production.”
The experts feel that the ongoing research has
brought them one step closer to expanding the options for male birth
control, providing the world’s 7.6 billion people with a much-needed option for
safe and reversible contraception.
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