First hormonal vaginal contraceptive ring

FDA Consumer, Nov-Dec, 2001

The FDA has announced approval of a flexible, transparent contraceptive ring that is inserted into the vagina. The product, called NuvaRing, releases a continuous low dose of the hormones etonogestrel and ethinyl estradiol, which are similar to the active ingredients in some oral contraceptives. The new birth control product is available by prescription only.

A woman inserts the ring herself, and it remains in the vagina for three weeks. She then removes the ring for one week, during which she will have her menstrual period. A new ring is used each month for continuous contraception.

Like oral contraceptives, NuvaRing is highly effective when used as directed. It's estimated that out of 100 women using NuvaRing for an entire year, one or two will become pregnant. Two large multi-center trials with more than 2,300 women were conducted in the United States, Canada, Europe, and Israel to evaluate NuvaRing's safety and effectiveness.

Women who use NuvaRing will receive a brochure describing how to use the product, as well as information on effectiveness, benefits, and risks. Side effects may include vaginal discharge, vaginitis, and irritation, and NuvaRing may increase the risk of blood clots, heart attack, and stroke. NuvaRing should not be used by women who smoke, or who have cardiovascular disease, blood clots, or certain types of cancer.

Organon Inc., headquartered in West Orange, N.J. and NV Organon, the Netherlands, developed the new vaginal ring.

COPYRIGHT 2001 U.S. Government Printing Office
COPYRIGHT 2008 Gale, Cengage Learning

 

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