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Is a contraceptive patch in the near future for American women? The Food and Drug Administration (FDA) is now reviewing the clinical research data on the novel birth control method.
The R.W. Johnson Pharmaceutical Research Institute in Raritan, NJ, under the same Johnson & Johnson corporate umbrella as Ortho-McNeil Pharmaceuticals, has submitted a New Drug Application (NDA) for the Ortho Evra transdermal system, a seven-day contraceptive patch. The application was filed in late December 2000.
Clinical trials for the patch have been completed, according to Mark Monseau, a company spokesman. As with any product under FDA review, the company declined to speculate on the drug’s possible approval, other than to note the FDA’s standard review period for an NDA is 12 months. If the patch does gain FDA approval, it would be the world’s first prescription transdermal contraceptive.
Two hormones in one patch
The patch relies on the progestin/estrogen combination of norelgestromin and ethinyl estradiol for its contraceptive effectiveness. Norelgestromin is the primary active metabolite of norgestimate, which is the progestin used in two Ortho-McNeil oral contraceptives (OCs): Ortho Tri-Cyclen and Ortho-Cyclen.
Evra can be worn on several areas of a woman’s body, but most typically is placed on the lower abdomen or buttocks. The patch is worn for one week at a time and is changed on the same day of the week three times a month. The fourth week is patch-free.
Evra is as effective as oral contraceptives, and patient compliance with the device may be even higher than with the pill, according to poster sessions presented at the May 2000 annual clinical meeting of the Washington, DC-based American College of Obstetricians and Gynecologists (ACOG).1,2 The first poster, a dosing trial that looked at three sizes of the patch, concluded that the 20 sq. cm patch provides high levels of suppression of ovarian activity and effective cycle control compared with Ortho-Cyclen while providing more complete suppression of follicular development.1
Data from the second poster session suggest women are more compliant with the patch than with oral contraceptives. Compliance with the patch was 93%, 94.4%, and 92.7%; whereas compliance with the two oral contraceptive preparations was 87.8% and 78.4%, respectively.2 Similar data were presented at the October annual meeting of the Washington, DC-based American Society for Reproductive Medicine.
What are the advantages offered by such a transdermal method of contraception? According to David Archer, MD, professor of obstetrics and gynecology and director of the Clinical Research Center at the Eastern Virginia Medical School in Norfolk, there are at least five:
• reduced compliance/motivation, since the transdermal system only has to be changed on a weekly basis;
• improved bleeding profile. According to the information presented at the ACOG meeting, there was little to no breakthrough bleeding associated with use of the Evra patch, notes Archer. He believes this reflects a consistent blood level of the steroid.
• continued contraceptive efficiency due to improved compliance;
• potential for fewer side effects, perhaps due to consistent low blood levels. Archer says he has not seen specific data on this issue;
• acceptance of "new and improved" contraceptives. Consumers like the idea of a new technique or device, so Evra may pique the interest of women who have stopped using OCs for other reasons, states Archer.
"Our patients enjoyed the convenience of once-a-week dosing rather than the daily dosing requirements of the birth control pill," confirms one of the clinical trials’ investigators, 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. "Many of these same women might also be candidates for the once-a-month shot (Lunelle, marketed by Pharmacia Corp. of Peapack, NJ), but they don’t like needles." (For information on the just-released monthly contraceptive injectable, see Contraceptive Technology Reports, enclosed in this issue, and Contraceptive Technology Update, December 2000, p. 144.)
The uniqueness of the patch application for contraception makes Evra intriguing, but its visibility might not be optimal for younger women seeking confidentiality, notes Nelson.
Disadvantages include, as with all patch technology, adhesive allergy or reaction, and problems with patch adherence, notes Sharon Schnare, RN, FNP, CNM, MSN, women’s health consultant and clinician with the Seattle King County Health Department in women’s and adolescent health care and the International District Community Health Center in Seattle.
"The contraceptive patch will add an important contraceptive option for women who cannot take pills or remember to take pills, and for women who do not want to have injections or use barrier methods such as diaphragms or cervical caps," observes Schnare. "As with all contraceptive methods, women should be encouraged to use condoms" for protection against sexually transmitted diseases, she says.
A big challenge for some women is the need for daily pill taking, reflects Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville. Even women who are excellent and consistent pill takers might live with a certain apprehension over what might happen if they miss pills and experience an unintended pregnancy.
"From this perspective, a weekly patch, which uses the same familiar hormones as are in contemporary OCs, is appealing indeed," says Kaunitz. "I believe the availability of Evra will increase the number of U.S. women who use modern effective methods of birth control."
1. Shangold G, Fisher AC, Rubin A. Pharmacodynamics of the contraceptive patch. Obstet Gynecol 2000; 95(4 Suppl 1):S36.
2. Creasy G, Hall N, Shangold G. Patient adherence with the contraceptive patch dosing schedule versus oral contraceptives. Obstet Gynecol 2000; 95(4 Suppl 1):S60. n