What is Ellaone?
Ellaone is a medicine that contains the active substance ulipristal acetate and is available as white tablets (30 mg).
What is Ellaone used for?
Ellaone is an emergency female contraceptive that must be taken within five days of unprotected sex or the failure of another contraceptive (for example, condom rupture during intercourse).
The medicine can only be obtained with a prescription.
See also: Morning-after pill
How is Ellaone used?
Ellaone should be taken as one tablet as soon as possible and no later than five days after unprotected sex or contraceptive failure. The tablet can be taken on a full or empty stomach. If vomiting occurs within three hours of taking it, another tablet should be taken. Ellaone can be taken at any time during the menstrual cycle.
How does Ellaone work?
In order for pregnancy to begin, ovulation must occur (release of the egg) followed by fertilization of the egg (fusion with a spermatozoon) and its implantation in the uterus. Progesterone, a sex hormone, stimulates the production of proteins that determine the timing of ovulation and prepares the uterine wall to receive the fertilized egg.
The active ingredient of Ellaone, the ulipristal acetate, acts as a progesterone receptor modulator, binding to receptors to which progesterone normally binds and thus inhibiting the action of the hormone. Thanks to its action on progesterone receptors, Ellaone prevents the establishment of pregnancy by intervening in ovulation and with possible modifications of the uterine wall.
What studies have been carried out on Ellaone?
The effects of Ellaone were first tested in experimental models before being studied in humans.
In one main study, Ellaone was administered to 1533 women (average age: 24 years) who had requested an emergency contraceptive for 2-5 days after the unprotected relationship or failure of another contraceptive. The main parameter of effectiveness was the number of women who had not been pregnant. This figure was subsequently compared with the number of women that would be expected to remain pregnant if they had not taken any contraception, a number calculated based on published percentages.
The pharmaceutical company also provided the results of a further comparison study between Ellaone and levonorgestrel (another drug used as an emergency contraceptive). This study was attended by women who took the medicine within the second day after unprotected sex or contraceptive failure.
What benefit has Ellaone shown during the studies?
Ellaone has been shown to be effective as an emergency contraceptive. Of the women who completed the main study, 2.1% (26 out of 1241) remained pregnant, or less than 5.5% of women who predictably would have been pregnant if they had not taken any contraception. Ellaone therefore avoided about three-fifths of predictable pregnancies. The other study, on women who had taken the medicine within two days of unprotected intercourse or contraceptive failure, also confirms the effectiveness of Ellaone.
What is the risk associated with Ellaone?
The most common side effects associated with Ellaone (or seen in more than 1 patient in 10) are abdominal pain and menstrual cycle disorders. For the full list of all side effects reported with Ellaone, see the Package Leaflet.
Ellaone should not be used in women who may be hypersensitive (allergic) to ulipristal acetate or any of the other ingredients. It cannot also be used in women who are already pregnant.
Why was Ellaone approved?
The Committee for Medicinal Products for Human Use (CHMP) has decided that Ellaone's benefits exceed i
risks in emergency contraception within five days of unprotected intercourse or contraceptive failure, and recommended that Ellaone be given marketing authorization.
Other information on Ellaone:
On May 15, 2009, the European Commission issued a marketing authorization for Ellaone to Laboratoire HRA Pharma, valid throughout the European Union.
For the full EPAR for Ellaone, click here.
Last update of this summary: 04-2009.
