The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: Ortho-McNeil Pharmaceutical
Approval Status: Approved November 2001
Treatment for: Contraception
General Information
Ortho Evra is approved as a once-a-week contraceptive for women. It is the first transdermal hormonal patch to be approved, as well as the first non-invasive form of birth control that, when used correctly, is 99 percent effective.
Ortho Evra is a one and three-quarter inch square patch that must be applied to the lower abdomen, buttocks, upper torso, or outer upper arm. A woman is able to swim, bathe, and exercise without the patch coming off. Each patch is worn for seven days before being replaced, for three weeks. The fourth week is treatment free, as with oral contraceptives.
Clinical Results
The approval of Ortho Evra is supported by data from clinical trials, conducted in more than 3,000 women, that compared the patch to oral contraceptives. When Ortho Evra is used correctly, the chance of becoming pregnant is approximately one percent. This is comparable to correct usage of the pill.
Side Effects
Adverse events associated with the use of Ortho Evra may include (but are not limited to) the following:
- Breast symptoms
- Headache
- Application site reaction
- Nausea
- Upper respiratory infection
- Menstrual cramps
- Abdominal pain
Mechanism of Action
Ortho Evra (norelgestromin/ethinyl estradiol) is a combination contraceptive that acts through supression of gonadotropins. The primary mechanism of action is the inhibition of ovulation, though other alterations include changes in the cervical mucus and endometrium. The patch delivers a steady flow of hormones through the skin and into the bloodstream.
Additional Information
For additional information on Ortho Evra, please visit Ortho Evra.
