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Dec. 14--Cramps, bloating and the mood swings associated with the monthly menstrual cycle could be severely minimized with a new continuous-use oral contraceptive in development that researchers say has proven to be safe and effective in a clinical trial.
But it could be as long as a year before the birth control pill, marketed as Lybrel, reaches the consumer because it still must earn approval by the federal Food and Drug Administration.
Researchers used a birth control pill consisting of synthetic hormones during the 18-month final stage trial, which enrolled 2,402 women between ages 18 and 49.
Lead researcher Dr. David F. Archer of the Eastern Virginia Medical School said traditional birth control regimens include 21 days of active hormones with seven days of placebos.
"It is felt that the relief of menstrual cycle symptoms during continuous use of the contraceptive is a significant improvement in the quality of life," he said. "This study marks the first time we have shown that it's safe to eliminate them [menstrual periods]."
However, some local doctors interviewed yesterday raised questions about the study's methodology and conclusions, with more than half, or 1,481 participants, dropping out. The participants also experienced some spot bleeding, which disappeared the longer they took Lybrel, according to the study published in the current issue of Contraception journal.
The study was funded by Wyeth Pharmaceuticals, which makes Lybrel. Archer is a paid consultant for the company.
Dr. Jill Maura Rabin, chief of the division of ambulatory care and head of uro-gynecology at Long Island Jewish Medical Center in New Hyde Park, said the new oral contraceptive "looks great" and could provide relief for a certain population of women whose monthly periods are fraught with severe symptoms.
Dr. J. Gerald Quirk, chairman of the Department of Obstetrics and Gynecology at the Stony Brook University Medical Center, said, "It is another safe and effective option for women looking for contraception but it isn't going to be for everybody."
Previously, there had been concern among researchers that without a monthly menstrual cycle to allow the uterus lining to shed, there would be an increased risk for it to grow too much, a condition known as endometrial hyperplasia.
There is already a birth control pill on the market that allows women to have a menstrual cycle just four times a year.
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Copyright (c) 2006, Newsday, Melville, N.Y.
Distributed by McClatchy-Tribune Business News.
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