First contraceptive patch offers once-a-week dosing
FDA approves Ortho Evra transdermal contraceptive
Women soon will have another option in birth control: the Ortho Evra transdermal contraceptive. Look for the contraceptive patch to be available in the first half of 2002, according to Raritan, NJ-based Ortho-McNeil Pharmaceutical, which will market the drug.
Ortho Evra is worn for one week at a time and is replaced on the same day of the week for three consecutive weeks. The fourth week, which is patch-free, allows a woman to have her menstrual period — similar to the regimen for birth control pills. Women can wear the patch on one of four areas of the body: the buttocks, abdomen, upper torso (front and back, excluding the breasts), or upper outer arm. Women who are candidates for the Pill also may be considered for the patch; those with contraindications to hormonal contraception should seek another method. (See "Who should not use Ortho Evra?," below.)
The contraceptive patch offers a convenient, effective form of birth control for women, especially for those who may struggle with daily pill-taking, says Anita Nelson, MD, professor in the obstetrics and gynecology department at the University of California in Los Angeles (UCLA) and medical director of the women’s health care clinic and nurse practitioner training program at Harbor-UCLA Medical Center in Torrance.
"We participated in the clinical trials and were very pleased to see how well-accepted this [method] was," says Nelson. (Contraceptive Technology Update has reported on the patch in three articles: October 1999, "Another option? Contraceptive patches are now under research" March 2001, "Patch now under regulatory review" and August 2001, "Contraceptive patch, ring: In U.S. by 2001?" Past CTU articles are available on the web site www.contraceptiveupdate.com. Click on "archives.")
While the price for the contraceptive patch has not yet been established, it will be comparable to that of birth control pills, Ortho-McNeil says. It will be available only in one color, beige; other colors, including a clear patch, are being evaluated for future development. The company has established a web site, www.orthoevra.com, and toll-free telephone number, (877) 227-2824 [(877) BC-PATCH], to provide information on the new contraceptive.
Review the results
Just-released data from the drug’s clinical trials shows that the patch provides effective contraception and cycle control and is well tolerated by women who use it.1 The patch was developed by R. W. Johnson Pharmaceutical Research Institute in Raritan; it and Ortho-McNeil are members of the New Brunswick, NJ-based Johnson & Johnson corporate family.
The results of the open-label, 73-center study were based on the experiences of 1,171 women who used the patch for six cycles and 501 women who used the method for 13 cycles. The treatment regimen for each cycle consisted of three consecutive seven-day patches (21 days) followed by one patch-free week.
The 20 cm3 patch used in the trial consisted of three layers: an outer protective layer of polyester; a medicated, adhesive middle layer; and a clear polyester release liner, removed before patch application. Each patch contained 150 mcg of the progestin norelgestromin and 20 mcg of the estrogen ethinyl estradiol. Women applied the patch to one of four anatomic sites: buttocks, upper outer arm, lower abdomen, or upper torso, excluding the breasts. New patches could be placed close to, but not on, the previous application site.
The life table estimates of the probability of overall and method-failure pregnancy through 13 cycles were 0.7% and 0.4%, respectively. Five method-failure pregnancies and one user-failure pregnancy occurred among 1,664 women treated for 10,994 cycles. The overall Pearl index was 0.71, and the method-failure Pearl index was 0.59. In a separate paper, researchers found the contraceptive patch comparable to a combination pill in terms of contraceptive efficacy and cycle control.2
Adverse events associated with patch use were typical of hormonal contraception, and most were mild-to-moderate in severity and not treatment limiting, the investigators state. The most common adverse events resulting in discontinuation were application site reactions (1.9%), nausea (1.8%), emotional lability (1.5%), headache (1.1%), and breast discomfort (1%).
Incidence of breakthrough bleeding was low throughout the study. Perfect compliance (defined as 21 consecutive days of dosing, followed by a seven-day drug-free interval; no patch could be worn for more than seven days) was achieved in 90% of subject cycles; only 1.9% of patches detached completely, according to the study results.
Watch the weight
In clinical trials, the product appeared to be less effective in women weighing more than 198 pounds (90 kg). Of the six pregnancies that occurred in the study, four were among women who weighed 198 pounds or more. Although this finding may suggest that the occurrence of pregnancy is associated with increased body weight, a separate meta-analysis of all patch studies will be published to offer more conclusive results.
Nelson believes that the research will indicate that the patch is most effective for women who weigh less than 198 pounds. Since oral contraceptives share similar doses of estrogen and progestin, it may well be time to re-examine the role of weight vs. efficacy in pills as well, Nelson observes.
Adhesion is good
The high rate of adhesion for the patch may well play a role in its efficacy, researchers point out in the new study. Based on experiences in the clinical trial, how hard is it to remove the patch at the end of its useful cycle?
A pending study will include data on the ease of removing the patch ("peel-force") after wearing the patch under normal conditions, says Kellie McLaughlin, Johnson & Johnson spokeswoman. The study also will examine adhesion during exercising and assess whether extreme conditions affect adhesion.
Will women wear it?
Women who participated in the trial enjoyed wearing the patch, says Nelson. Some even displayed it on the upper arm, kind of a "badge of courage," she notes. Clinicians had to instruct women not to apply decals or other decorative markings on the patches.
While several different patch colors, including a clear model, were evaluated in the clinical trials, beige was selected because it maintained its appearance best over the seven-day wear period. The manufacturer continues to examine development of other color options.
For those who want total privacy with their birth control decision, the patch may not be the right option since it must be worn, says Nelson. But for those who have trouble with daily pills, what some term the "pill in a patch" may offer an effective option.
"There is a lot of anxiety about [pill-taking]," she states. "I think the patch will make it easier for women to use it."
References
1. Smallwood GH, Meador ML, Lenihan JP, et al. Efficacy and safety of a transdermal contraceptive system. Obstet Gynecol 2001; 98:799-805.
2. Audet MC, Moreau M, Koltun WD, et al. Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs. an oral contraceptive: A randomized controlled trial. JAMA 2001; 285:2,347-2,354.
Who should not use Ortho Evra?
Some women should not use the Ortho Evra contraceptive patch. Check for any of the following conditions:
- A history of heart attack or stroke
- Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
- A history of blood clots in the deep veins of the legs
- Chest pain (angina pectoris)
- Known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina
- Unexplained vaginal bleeding
- Hepatitis or yellowing of the whites of the eyes or of the skin (jaundice), during pregnancy or during previous use of hormonal contraceptives
- Liver tumor (benign or cancerous)
- Known or suspected pregnancy
- Severe high blood pressure
- Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
- Headaches with neurological symptoms
- Use of oral contraceptives
- Disease of heart valves with complications
- Need for a prolonged period of bed rest following major surgery
- An allergic reaction to any of the components of Ortho Evra
Source: U.S. prescribing information for Ortho Evra, Ortho-McNeil Pharmaceutical, Raritan, NJ.
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