After more than a decade of work, govern-
ment researchers in the US are ready to
test an unusual birth control method for
men—a topical gel that could prevent the
production of sperm.
And no, gentlemen, you don’t rub it on
The clinical trial, which begins in April
and will run for about four years, will be the
largest e;ort in the US to test a hormonal
form of birth control for men.
Currently, the most e;ective options
men have for birth control are condoms
or a vasectomy. In the last major study of a
hormonal male contraceptive, which took
place in Europe from 2008 to 2012, participants received injections of hormones
every two months. The shots suppressed
sperm production and prevented the men’s
female partners from getting pregnant, but
they also gave men severe mood swings and
other serious side e;ects.
The new gel contains two synthetic
hormones, testosterone and a form of pro-
gestin. Progestin blocks the testes from
making enough testosterone for normal
sperm production. The replacement testos-
terone is needed to counteract the hormone
imbalances the progestin causes but won’t
make the body produce sperm.
More than 400 couples will participate
in the study, which will take place at sites in
the US, the UK, Italy, Sweden, Chile, and
Kenya. Men in the trial will take home a
pump bottle of the gel and rub about half
a teaspoon of it on their upper arms and
shoulders every day. The gel dries within
“It’s not a lot of e;ort. It’s just remembering to use it every day,” says Diana
Blithe, program director for contraception development at the National Institute
of Child Health and Human Development,
part of the National Institutes of Health.
The gel can suppress sperm levels for
about 72 hours, so if men forget a dose,
“there is a bit of forgiveness,” says Régine
Sitruk-Ware, distinguished scientist at the
Population Council, a nonprofit for reproductive health that is sponsoring the trial
alongside the NIH.
Men will use the gel for at least four
months while their partners also use some
form of female contraception. Researchers
will monitor the men’s sperm levels, which
need to drop to less than one million per
milliliter to e;ectively prevent pregnancy,
according to Blithe. Once the sperm count
is low enough, the women will go o; their
birth control. The couples will then use the
contraceptive gel as their only form of daily
birth control for a year.
The method was shown to be e;ective
in an initial six-month study. But it involved
two types of gels that had to be applied to
di;erent parts of the body, so Blithe’s NIH
team worked with researchers at the Population Council to reformulate the hormones
and combine them into one gel.
Still, the question is: will men use it?
Historically, there hasn’t been much
interest from pharmaceutical companies
in a male contraceptive. Running clinical
trials takes years and is hugely expensive, so
it’s a risky endeavor when lots of options for
female contraception already exist.
But researchers like Sitruk-Ware think
views are changing, and that men, espe-
cially younger men, will be open to using
a contraceptive drug. “This is about gender
equity,” she says. “Men would also like to be
able to regulate their own fertility and not
be forced into fatherhood.”
Men’s attitudes on their role in contra-
ception vary by country, but a 2010 survey
indicated that at least 25 percent of men
worldwide would consider using a hor-
monal contraceptive. —Emily Mullin
A contraceptive gel for men is
about to go on trial
It’s expected to deliver hormones more effectively than injections or pills.
Gene therapy for blindness
$425,000 per eye
TO MARKET Spark Therapeutics recently announced the price tag for Lux-
turna, the only FDA-approved gene therapy for an inherited type
of blindness. That price is $425,000 per eye—making it the most
expensive dose of a drug in the US. At $850,000 for both eyes,
that’s nearly nine times the median net worth of an American
family. The therapy is meant to restore eyesight in people with a
specific genetic mutation that causes degeneration of the retina.
Spark hasn’t said how many people that is, but it may be fewer
than 30 patients a year. Is it worth it? While the therapy does stop
eyesight from getting worse and even restores some sight, it’s not
a cure, and no one’s sure how long the e;ects last.—Emily Mullin