• Summary
• Credits

1. The Long Road of Contraceptive Development
2. Vaginal Rings
3. Transdermal Contraception
• Combined Patches
• Spray-On Contraceptives
4. Contraceptive Implants
5. Combined Injectables
6. Condoms
7. Fertility Awareness-Based Methods
8. Oral Contraceptives
9. Intrauterine Devices
10. Transcervical Female Sterilization
11. Male Hormonal Contraception
12. Bibliography
13. Web Supplements

• Clinical trials assess effectiveness and safety of new contraceptives
• New low-dose DMPA formulation
• More long-term choices for men

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Transdermal Contraception

Transdermal Contraception Description: Patches, sprays, or gels, applied weekly or daily, that transfer hormones through the skin. Stage of development: One product marketed. Effectiveness: Patches—0.8 to 1.3 pregnancies per 100 women in the first year as typically used. How they work: Patches release estrogen and progestin through the skin, preventing ovulation, thickening the cervical mucus, and suppressing endometrial growth. What’s new? Patches require attention just once a week. Used correctly at higher rates than combined OCs. Sprays or gels transfer fast-drying progestins onto the skin. They are absorbed immediately and diffuse into the bloodstream.

A new hormonal contraceptive method, the patch, works transdermally—that is, by slowly releasing a combination of progestin and estrogen through the skin. The new contraceptive patches are user-controlled and require attention just once a week (210, 285). Other transdermal contraception in development includes sprays and gels.

The only contraceptive patch on the market today is Ortho Evra^® (also called Evra outside the US), developed by Ortho-McNeil Pharmaceutical. It was approved by the US FDA in 2002 and is available in Europe and in Canada, Hong Kong, Singapore, South Korea, and the US.

The combined patch delivers 150 µg of the progestin norelgestromin and 20 µg of the estrogen ethinyl estradiol per day. A user wears a patch for one week, after which she must replace that patch with a new one each week for a total of three weeks, followed by one week with no patch. The hormones in the patch protect against pregnancy by preventing ovulation, thickening cervical mucus, and suppressing endometrial growth. More than 70,000 of the patches have been clinically tested worldwide among more than 3,300 women (19).

Ortho Evra is a square patch, each side about 4.45 centimeters (1.75 inches) long, resembling a light brown bandage. The developer is investigating additional colors to match a greater variety of skin tones. The patch contains three layers: an outer protective layer of polyester, a medicated adhesive middle layer, and a clear polyester release liner, which is removed just before application. The adhesive layer continuously delivers hormones through the skin into the bloodstream. The patch can be placed on the buttocks, lower abdomen, upper outer arm, or the upper body (front or back, but not on the breasts).

The patch adheres well to the skin, allowing women to perform regular daily activities such as bathing, swimming, working, and exercising without interruption even in warm, humid climates (280). The patch falls entirely off in about 2% of cases, especially if women place it where they have applied creams, oils, powder, or make-up (22, 225).

Women who like combined OCs but have trouble remembering daily pill-taking may be good candidates for the Ortho Evra patch (44). It provides effectiveness and cycle control similar to OCs’ as correctly used. In clinical trials women liked the patch as much as OCs (100, 209).

Another patch is in development. Schering AG in Germany is developing a weekly combined patch that is in phase III clinical trials. This clear patch measures 3.16 centimeters (1.25 inches) on each side (half the size of Ortho Evra) and releases 50 µg per day of the progestin gestodene and 18 µg of the estrogen ethinyl estradiol (101, 202). Because most of the published research is on Ortho-McNeil’s patch, the following discussion focuses on Ortho Evra.

Correct use. Correct use entails applying the first patch within five days after menstruation begins and then changing it each week for three weeks. The patch is applied to a new location each week and once in place should not be moved. For the fourth week no patch is worn, to allow for withdrawal bleeding (179, 280). Women may be able to use the patch continuously, using a fourth patch in the fourth week, skipping the withdrawal bleeding period. Studies are in progress to evaluate continuous use (20).

Women report using the patch correctly more often than they use OCs correctly. In a comparative study, for example, women used the patch correctly in 88% of their cycles compared with 78% of cycles among OC users (22). In a clinical trial of the patch alone, women used it correctly in 90% of cycles (225).

Younger women who have trouble following rules for correct use of OCs may find it easier to use the patch correctly. One study comparing correct use among patch users and OC users found that patch users under age 20 reported using it correctly in 89% of cycles while OC users under age 20 reported taking their pills correctly in only 68% of cycles (14).

Effectiveness. When the Ortho Evra patch is used correctly, 0.6 of every 100 women (6 per 1,000) become pregnant in the first year of use according to pooled data from three clinical studies (285). Even when not used correctly all of the time, the patch is still highly effective; in typical use 0.8 of every 100 women (8 per 1,000) become pregnant in the first year of use (285). Another international multicenter study found a correct-use pregnancy rate of 1.1 per 100 women and a typical-use rate of 1.3 per 100 women, a rate lower than for women in the control group using combined OCs (22).

The same analysis found a lower effectiveness rate among women weighing more than 198 pounds (90 kgs). While the reasons that weight may affect the effectiveness of the Ortho Evra patch are unclear (44, 285), a study that found similar results among OC users hypothesized either that heavier women more rapidly metabolize the hormones, or that extra fat absorbs the steroids so there are reduced levels of circulating steroids in the blood (107).

Side effects. The most commonly reported side effects of the Ortho Evra patch are skin irritation or rash at the site of application, affecting about 20% of users in clinical trials (22). Other reported side effects are those also commonly associated with combined OC use.

The incidence of breakthrough bleeding and spotting is low among users of the Ortho Evra patch and decreases the longer they use it (225). One large clinical trial found that during the first month of use 18% of users reported breakthrough bleeding and spotting, significantly more than among combined OC users. After the second month, however, the incidence of bleeding irregularities declined among patch users, and there were no significant differences in bleeding or spotting thereafter (22).

The progestin Nestorone, appropriate for breastfeeding women, can be delivered transdermally not only through a patch but also through a spray or gel. Phase I clinical trials of the Nestorone Metered Dose Transdermal System, a daily progestin-only spray-on contraceptive, began in Australia in 2004. The spray-on approach is a new technique for transferring a preset dose of fast-drying hormones onto the skin. The spray is absorbed almost instantaneously, so there is no risk of washing it off. The hormone collects as a reservoir within the skin, from which it then slowly diffuses into the bloodstream (279). In a clinical trial a Nestorone gel applied to the skin daily for three months suppressed ovulation in 83% of participants applying 1.2 mg per day (215).

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