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 While the device may become a real convenience for American women,
its global impact may be even larger since it will offer women who
have little access to pharmacies or electricity for refrigerators
the ability to decide when they wish to become pregnant.
"This is a very exciting addition to the options for women to
prevent unintended pregnancy," said study coauthor Dr. Erika Banks,
vice-chair of obstetrics and gynecology at the Albert Einstein and
Montefiore Medical Center. "The advantages are huge in that women
don't have to go to the pharmacy every month and don't have to have
a refrigerator to store them in. Patients loved it."
Other contraceptive rings don't last as long and do need to be
stored in refrigerators.
The new ring-shaped device is made of soft plastic and is around two
inches in diameter. It prevents pregnancy through the slow release
of the hormones progesterone and estrogen, in forms that don't need
to be refrigerated, Banks explained. "They are flexible and you can
pinch the sides together and push them up into the vagina," she
added. "Once inside, it gets to be whatever shape the vagina is."
Dubbed Annovera, the device was developed by the nonprofit
Population Council and was approved by the Food and Drug
Administration in August 2018. It will be sold in the U.S. market by
TherapeuticsMD, Inc., starting later this year or in 2020. The
company has not announced the price of Annovera but has agreed to
provide significantly reduced pricing to family planning clinics
serving lower-income women.
The Population Council is planning to make the device available to
women in developing countries, which was the main audience it was
designed for, said coauthor Ruth Merkatz, director of clinical
development at the Population Council.
One strategy may be "trying to get companies in other parts of the
world licensed to make it," Merkatz said. "Our whole focus was women
in the developing world. That's why we worked so hard to develop it.
It's not easy to formulate a contraceptive - or any medication -
with enough medication in it to last a full year and be effective
without the need for refrigeration."
While women are told they can take the rings out for two hours at a
time, presumably for intercourse, "you can wear them while having
sex," Banks said. "Men don't notice when they're in there and the
few who do notice it doesn't seem to bother."
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The new device was tested in two large, identically designed trials,
one at 15 U.S. academic and community sites and one at 12 U.S. and
international academic and community sites. As reported in The
Lancet Global Health, the trials were run between 2006 and 2009. The
2,265 participants, ages 18 to 40, were told they should wear the
rings for 21 days and take them out for seven, thus mimicking the
normal menstrual cycle. They were also told they could periodically
take the rings out, but for no more than two hours at a time, since
the efficacy of the contraceptive might be affected if the rings
were removed for longer periods.
When the data from the trials were analyzed, the device turned out
to be 97.5% effective, meaning that if 1,000 women used the device,
25 could become pregnant. The researchers followed up on 290 of the
women and found that all had started to menstruate normally once
they stopped using the rings, and 24 of the 38 who had wanted to
become pregnant did so within six months of ring removal. The new
study did not report on side effects from the ring.
The new device is "fantastic," said Dr. Leena Nathan, an assistant
clinical professor of obstetrics and gynecology at UCLA Health in
Los Angeles. "I would offer this to my patients and encourage them
to give it a try."
A big advantage is that women don't have to think about it once it's
inserted and they don't need a doctor to insert it, Nathan said.
"And it's pretty easy to stop. If the woman doesn't like it she can
just pull it out."
"It's awesome that it works for a full year," Nathan said. "This
will change the landscape for us."
SOURCE: http://bit.ly/2YUWR7V and http://bit.ly/2YUX5vN Lancet
Global Health, online June 20, 2019.
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