14 DAY TRIAL // This is the dream of many women and now it has become reality.
On Tuesday, the U.S. Food and Drug Administration is expected to announce the approval of Lybrel, developed by Wyeth, the first contraceptive pill to completely eliminate menstruation in women on an indefinite period of time.
This is the fourth new oral contraceptive that changes the standard schedule of 21 daily active pills, mimicking a woman's monthly cycle.
Yaz and Loestrin 24 shorten the period to three days or less and Seasonique - the newest variant of Seasonale - reduces menstruations from one to three months.
Surveys revealed that 50 % of the women would like not to experience any periods and most would prefer them to "happen" less often. This can be done easier and less costly by skipping the fake pills (after the 21 active ones) or replacing birth-control patches or vaginal rings more often.
Lybrel sales are estimated to $40 million this year and $235 million by 2010. U.S. Seasonique sales, launched in August 2006, reached $6.1 million in the first quarter of 2007. Seasonale peaked at about $100 million while Yaz, launched in August 2006, presented first-quarter sales of $35.6 million; Loestrin 24, launched in April 2006, hit $34.4 million.
There is a vivid debate about whether or not to suppress a woman's menstruation. "Menstrual suppression itself is unnatural," said Baltimore health psychologist Paula S. Derry, pointing out that there are no long-term studies on the subject.
But researches testing much higher hormone concentrated pills found no harm for up to 10 years. Most doctors signal the uselessness of the monthly bleeding in women, fact which causes health problems from anemia to epilepsy in many subjects. They signal that women have been playing with nature since the emergence of the birth control pills and now they experience 450 periods, while only 50 or so in the times when they spent most of their fertile life periods pregnant or breast-feeding. "It allows women to put their menstrual cycle on hold and reduces 17 related symptoms, from irritability to bloating, based on one small study. Lybrel contains the lowest dose of two hormones widely used in birth-control pills, ethinyl estradiol and levonorgestrel", said Dr. Amy Marren, director of clinical affairs for Wyeth Pharmaceuticals.
"That might cause too much breakthrough bleeding, already a problem with some newer pills with low hormone doses," warned Dr. Lee Shulman, a Chicago obstetrician-gynecologist, head of the Association of Reproductive Health Professionals.
In Lybrel trials, 59 % of women did not experience bleeding after six months, but 18 % of women did display spotting and breakthrough bleeding. "You're now basically trading scheduled bleeding for unscheduled bleeding, and I don't know whether American women will buy into that," Shulman said.