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Friday, 29 January 2010 17:18 GMT
HRA's Ellaone non-inferior to Norlevo at preventing pregnancy - Lancet
PARIS, Jan 29 (APM) - HRA Pharma's emergency contraceptive Ellaone (ulipristal acetate) has shown to be non-inferior to Norlevo (levonorgestrel) at preventing pregnancy up to 120 hours after unprotected sex.
The non-inferiority study was published online by The Lancet on Friday.
The main results of the HRA-financed study were presented at the European Society of Gynaecology meeting in Rome in September 2009. The Lancet online publication provides more detailed results, particularly concerning the time lapsed between unprotected sex and treatment.
Ellaone was launched in France in October for use as emergency contraception up to 120 hours after unprotected sex.
The multicentre randomised comparative study enrolled 2,221 women who presented to a participating clinic within 120 hours of unprotected sexual intercourse. They were either administered 1.5 mg of levonorgestrel or 30 mg of ulipristal. This was a single blind study: only the participants did not know which of the two treatments they were given.
It was possible to evaluate treatment efficacy in 1,899 of the women. Out of 1,696 who were given the treatment within 72 hours, which corresponds to the indication for Norlevo, risk of pregnancy was significantly reduced by 32%, pregnancy rate was 1.8% for ulipristal compared with 2.6% for levonorgestrel.
In the 203 women who received the treatment between 72 and 120 hours after unprotected sex, there were three pregnancies among women who were administered Norlevo compared with none among the women who were administered Ellaone, and the difference is statistically significant.
In the 1,899 patients who received treatment within 120 hours, risk of pregnancy was reduced by 43% with ulipristal, in comparison with levonorgestrel.
The researchers also combined the data from the comparative study with those of an earlier study that enrolled 1,546 women and compared the two treatments but only up to 72 hours after unprotected sex, and carried out a meta-analysis of the combined data to increase the statistical power of their results.
Results show that the pregnancy rate was significantly lower with ulipristal than with levonorgestrel when treatment was taken from 0 to 24 hours (risk reduced by 65%), from 0 to 72 hours (risk reduced by 42%) or from 0 to 120 hours (risk reduced by 45%) after unprotected sex.
In the randomised study up to 120 hours after unprotected sex, two serious adverse events were "judged possibly related to emergency contraception": one case of dizziness in the ulipristal group and a molar pregnancy in the levonorgestrel group.
(The Lancet, online publication of January 29)
cd/aki/hlc
[17945] 29/01/2010 17:18 GMT - GYNAECO
The non-inferiority study was published online by The Lancet on Friday.
The main results of the HRA-financed study were presented at the European Society of Gynaecology meeting in Rome in September 2009. The Lancet online publication provides more detailed results, particularly concerning the time lapsed between unprotected sex and treatment.
Ellaone was launched in France in October for use as emergency contraception up to 120 hours after unprotected sex.
The multicentre randomised comparative study enrolled 2,221 women who presented to a participating clinic within 120 hours of unprotected sexual intercourse. They were either administered 1.5 mg of levonorgestrel or 30 mg of ulipristal. This was a single blind study: only the participants did not know which of the two treatments they were given.
It was possible to evaluate treatment efficacy in 1,899 of the women. Out of 1,696 who were given the treatment within 72 hours, which corresponds to the indication for Norlevo, risk of pregnancy was significantly reduced by 32%, pregnancy rate was 1.8% for ulipristal compared with 2.6% for levonorgestrel.
In the 203 women who received the treatment between 72 and 120 hours after unprotected sex, there were three pregnancies among women who were administered Norlevo compared with none among the women who were administered Ellaone, and the difference is statistically significant.
In the 1,899 patients who received treatment within 120 hours, risk of pregnancy was reduced by 43% with ulipristal, in comparison with levonorgestrel.
The researchers also combined the data from the comparative study with those of an earlier study that enrolled 1,546 women and compared the two treatments but only up to 72 hours after unprotected sex, and carried out a meta-analysis of the combined data to increase the statistical power of their results.
Results show that the pregnancy rate was significantly lower with ulipristal than with levonorgestrel when treatment was taken from 0 to 24 hours (risk reduced by 65%), from 0 to 72 hours (risk reduced by 42%) or from 0 to 120 hours (risk reduced by 45%) after unprotected sex.
In the randomised study up to 120 hours after unprotected sex, two serious adverse events were "judged possibly related to emergency contraception": one case of dizziness in the ulipristal group and a molar pregnancy in the levonorgestrel group.
(The Lancet, online publication of January 29)
cd/aki/hlc
[17945] 29/01/2010 17:18 GMT - GYNAECO
