FDA OKs 'No-Period' Birth Control Pill
FDA OKs 'No-Period' Birth Control Pill
May 22, 2007 -- The FDA has approved Lybrel, the first low-dose contraceptive pill that gives women an option to stop their menstrual cycle for an indefinite period of time.
However, women using Lybrel will most likely have unplanned breakthrough bleeding or spotting, according to the FDA.
Women should consider Lybrel's no-period convenience vs. the chance of having breakthrough bleeding or spotting, notes Daniel Shames, MD, deputy director of the Office of Drug Evaluation III at the FDA's Center for Drug Evaluation and Research.
"I think each woman and her health care provider will have to look at the data, which we have explicitly defined in our labeling, and decide if this form of contraception is appropriate for her," Shames told reporters at a news conference.
This newest form of birth control, developed by Wyeth Pharmaceuticals, contains 90 micrograms of levonorgestrel and 20 micrograms of ethinyl estradiol -- a combination similar to that found in other low-dose oral contraceptives. The difference here: Lybrel replaces the four- to seven-day placebo pill with continuous daily dosing for nonstop birth control with no menstrual periods.
"Wyeth developed this contraceptive so that women may have an additional option to manage their cycles. The studies to support this product are a reflection of our longtime commitment to innovation in women's health," said Ginger Constantine, Wyeth's vice president of Women's Health Care and Bone Repair, in 2005 when the new drug application was made.
The FDA approved Lybrel based on two clinical trials, each lasting for one year, of more than 2,400 women aged 18-49.
The trials showed Lybrel to be a safe and effective contraceptive when used as directed.
Lybrel's labeling provides information on breakthrough bleeding and spotting.
"Many of the women that had bleeding or spotting dropped out" of the clinical trials, Shames says. "By the end of the study, only half of the women were in the study."
Of the women who started the clinical trials, "maybe 30% or 35% had no bleeding or spotting" after 13 cycles (about a year), says Shames.
However, women using Lybrel will most likely have unplanned breakthrough bleeding or spotting, according to the FDA.
Women should consider Lybrel's no-period convenience vs. the chance of having breakthrough bleeding or spotting, notes Daniel Shames, MD, deputy director of the Office of Drug Evaluation III at the FDA's Center for Drug Evaluation and Research.
"I think each woman and her health care provider will have to look at the data, which we have explicitly defined in our labeling, and decide if this form of contraception is appropriate for her," Shames told reporters at a news conference.
About Lybrel
This newest form of birth control, developed by Wyeth Pharmaceuticals, contains 90 micrograms of levonorgestrel and 20 micrograms of ethinyl estradiol -- a combination similar to that found in other low-dose oral contraceptives. The difference here: Lybrel replaces the four- to seven-day placebo pill with continuous daily dosing for nonstop birth control with no menstrual periods.
"Wyeth developed this contraceptive so that women may have an additional option to manage their cycles. The studies to support this product are a reflection of our longtime commitment to innovation in women's health," said Ginger Constantine, Wyeth's vice president of Women's Health Care and Bone Repair, in 2005 when the new drug application was made.
The FDA approved Lybrel based on two clinical trials, each lasting for one year, of more than 2,400 women aged 18-49.
The trials showed Lybrel to be a safe and effective contraceptive when used as directed.
Breakthrough Bleeding
Lybrel's labeling provides information on breakthrough bleeding and spotting.
"Many of the women that had bleeding or spotting dropped out" of the clinical trials, Shames says. "By the end of the study, only half of the women were in the study."
Of the women who started the clinical trials, "maybe 30% or 35% had no bleeding or spotting" after 13 cycles (about a year), says Shames.
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