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| |  Ulipristal Acetate Is Alternative Choice to Levonorgestrel for Emergency Contraception NEW YORK -- January 28, 2010 -- The emergency contraception drug ulipristal acetate (UA) prevents more pregnancies than a widely-used alternative, levonorgestrel, according to a study published online first and appearing in an upcoming edition of The Lancet. Furthermore, UA has recently been licensed for use up to 5 days after unprotected intercourse, compared with just 3 days for levonorgestrel. Thus women and health-care providers now have an alternative choice for emergency contraception. Anna Glasier, NHS Lothian, Edinburgh, United Kingdom, and colleagues performed their own trial, and also combined their results with a previous study. Their own trial took place in the UK, Ireland, and the United States. Women with regular menstrual cycles who presented to a participating family planning clinic requesting emergency contraception within 5 days of unprotected sexual intercourse were eligible for enrolment in this randomised trial. A total of 2,221 women were randomly assigned to receive a single dose of UA 30 mg (n = 1,104) or levonorgestrel 1.5 mg (n = 1117) orally. Participants did not know which treatment they were receiving but investigators did. Follow-up was done 5 to 7 days after expected onset of the woman’s next expected period. The primary endpoint was pregnancy rate in women who received emergency contraception within 72 hours of unprotected sexual intercourse. The final analysis excluded women lost to follow-up, those aged over 35 years, women with unknown follow-up pregnancy status, and those who had re-enrolled in the study - and consisted of 1,694 women, of whom 844 in the UA group and 852 in the levonorgestrel group received emergency contraception within 72 hours of sexual intercourse. There were 15 pregnancies in the UA group (1.8%) and 22 in the levonorgestrel group (2.6%). In 203 women who received emergency contraception between 3 and 5 days after sexual intercourse, there were 3 pregnancies, all in the levonorgestrel group. The most frequent adverse event was headache (UA, 213 events [19.3%] in 1104 women; levonorgestrel, 211 events [18.9%] in 1117 women). Two serious adverse events were judged possibly related to use of emergency contraception; a case of dizziness in the UA group and a molar pregnancy in the levonorgestrel group. In the meta-analysis (0-72 hours), there were 22 (1.4%) pregnancies in the UA group and 35 (2.2%) in the levonorgestrel group. Combination of data from the 2 studies allowed analysis of a sample sufficiently large to show that UA almost halved the risk of becoming pregnant compared with levonorgestrel in women who received emergency contraception within 120 hours (5 days) after sexual intercourse. If emergency contraception was used within 24 h of unprotected sexual intercourse (when a third of participants in the study presented for emergency contraception), the risk of pregnancy was reduced by almost two-thirds compared with levonorgestrel. “The estimated expected pregnancy rate in our trial was less than 6%, so arguably over 90% of participants did not need to use emergency contraception,” the authors said. “The difficulty, however, is in identifying this small population of women.” The authors point out that, since levonorgestrel has been used by many millions of women in varying doses, it can be made available without prescription. However, although UA could be made available through pharmacies and via nurses, it cannot be made as easily accessible as levonorgestrel until more safety data become available. “Despite the issues around health-care service delivery, ulipristal acetate provides women and health-care providers with an alternative choice for emergency contraception that can be used up to 5 days after unprotected sexual intercourse,” the authors concluded.
SOURCE: The Lancet
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