FDA Approves Monthly Contraceptive Alternative

The Food and Drug Administration on Wednesday approved the first hormone-based contraceptive that can provide birth control for an entire month at a time.

The device, called NuvaRing, consists of a flexible, transparent and colorless ring about 3 inches in diameter that women insert vaginally once a month. The ring releases a continuous dose of the hormones estrogen and progestin, the same ones used in oral contraceptives.

“It has the same effectiveness as oral contraceptives and has the same risks and side effects,” said Dena Hixon, a medical officer with the FDA’s division of reproductive and urologic products.

“Essentially, this is an option for women who want birth control but don’t like taking a pill every day,” she said. “Currently, there is nothing else like it for female contraception.”

Each ring remains in the vagina for 21 days and is then removed and discarded. A new ring is inserted on or before the fifth day of the menstrual period. In clinical trials for the FDA in the United States and Europe, the contraceptive ring prevented pregnancy in more than 98% of women using it for one year.

NuvaRing is produced by the Dutch company Organon Inc., which has offices in West Orange, N.J., and will require a prescription. The company said it will begin selling the new contraceptive by mid-2002.

Hixon said 14% of women in NuvaRing clinical trials had vaginal infections or symptoms but that some would have had them anyway.

“There is a small chance of infection from the ring, and occasionally women can feel its presence,” she said. “But overall it was well accepted and appreciated.”