Is the EVRA (norelgestromin and ethinyl estradiol) patch a suitable contraceptive option for a female of reproductive age with no significant medical history, such as blood clots, stroke, or estrogen-sensitive cancers?

EVRA Patch as a Contraceptive Option

The EVRA patch (norelgestromin/ethinyl estradiol transdermal system) is a suitable and effective contraceptive option for healthy reproductive-age women without contraindications, though it carries a higher estrogen exposure (1.6 times) and potentially increased VTE risk compared to low-dose oral contraceptives, making other combined hormonal methods potentially safer first-line choices. 1

Mechanism and Administration

• The EVRA patch delivers 150 mcg norelgestromin and 35 mcg ethinyl estradiol daily through transdermal absorption 2, 3
• Application involves wearing one patch weekly for 3 consecutive weeks, followed by 1 patch-free week during which withdrawal bleeding occurs 1
• The patch can be placed on the abdomen, upper torso, upper outer arm, or buttocks, with the buttock being the most preferred site among adolescents 2

Efficacy Profile

• Typical use failure rate is 9%, comparable to combined oral contraceptives 1, 2
• Perfect use failure rate is less than 1% in women weighing under 198 pounds 2
• Efficacy is reduced in women weighing more than 198 pounds (90 kg), with perfect use failure rates of 0.9% versus 0.3% in lighter women 2, 4

Critical Safety Considerations

Increased Estrogen Exposure

• The patch delivers 1.6 times higher estrogen exposure compared to 20-35 mcg combined oral contraceptives 1
• This increased exposure led to FDA black box warnings and multiple label revisions, most recently in August 2012 1

Venous Thromboembolism Risk

• Five US studies (one with statistically significant findings) suggest a possible increased VTE risk compared to low-dose COCs, with odds ratios ranging from 1.2 to 2.2 1
• Despite these concerns, the patch remains an important option when weighed against the risks of unplanned pregnancy, which itself increases VTE risk 1
• Other combined hormonal methods may be safer first-line choices, particularly for patients interested in extended cycling 1

Contraindications (Must Screen Before Prescribing)

The following conditions represent absolute contraindications 2:

• Active or history of venous thromboembolism
• Arterial disease
• Breast cancer
• Hepatic disease
• Undiagnosed vaginal bleeding
• Pregnancy

Advantages Over Oral Contraceptives

Compliance Benefits

• Self-reported perfect compliance with the patch (88.2%) was significantly better than with combined oral contraceptives (77.7%) 5
• Early studies demonstrated better adherence among 18-19 year-olds, with adolescent studies showing 87-93% perfect patch use 1
• Weekly dosing regimen is simpler than daily pill-taking 1, 6

Practical Advantages

• Gastrointestinal disturbances (nausea, vomiting) do not prevent efficacy, unlike oral contraceptives 4
• Patch detachment requiring replacement occurs in only 4.6% of cases with normal daily activity 5
• Physical exercise, water immersion, and humid climates do not significantly affect patch adhesion 6

Important Caveats About Continuation

A critical pitfall: While initial compliance may be better with the patch, continuation rates may actually be lower than with oral contraceptives. One prospective study of 1,230 women found only 57% continuation of the patch at 1 year compared to 76% continuation of pills (P = 0.004) 1. This suggests that women who self-select non-daily methods may have behavioral characteristics that interfere with long-term adherence to any method 1.

Side Effect Profile

Common Adverse Effects

• Breast tenderness (more common in first two cycles, mild to moderate in 85% of cases) 5
• Breakthrough bleeding and spotting (more common in cycles 1-2, but not significantly different by cycle 3) 5
• Application site reactions (most common reason for discontinuation at ≤3.2%) 6
• Dysmenorrhea, nausea, and vomiting 1

Discontinuation Rates

• Patch users discontinued early more often than COC users, with odds ratios of 1.59 (95% CI 1.26-2.00) and 1.56 (95% CI 1.18-2.06) 7
• Patch users also had more discontinuation due to adverse events compared to COC users 7

Prescribing Protocol

Initial Prescribing

• Same-day initiation is recommended for immediate contraceptive effect 2
• No backup contraception is needed if started within the first 5 days of menses 2
• If started at other times, backup contraception should be used for 7 consecutive days 2
• Baseline assessment should include confirmation of pregnancy status and blood pressure measurement 2

Managing Delayed Application or Detachment

If delayed or detached less than 48 hours:

• Apply a new patch immediately and keep the same patch-change day 2
• No backup contraception needed 2

If delayed or detached 48 hours or more:

• Apply a new patch immediately and start a new 4-week cycle 2
• Use backup contraception or avoid intercourse until a patch has been worn for 7 consecutive days 2
• Consider emergency contraception if delayed application occurred during the first week and unprotected intercourse occurred in the previous 5 days 2

Medical Eligibility by Age

• Women under age 40 can use the patch without age-related restrictions (Category 1) 1
• Women aged 40-45 years can generally use the patch (Category 2), though cardiovascular risk increases with age 1
• Women over 45 years can generally use combined hormonal contraceptives (Category 2), but individual risk factors must be carefully assessed 1

Clinical Bottom Line

For a healthy reproductive-age woman without contraindications (no history of blood clots, stroke, or estrogen-sensitive cancers), the EVRA patch is a suitable contraceptive option that offers excellent compliance advantages and comparable efficacy to oral contraceptives 1, 5, 6. However, the increased estrogen exposure and potential VTE risk should prompt consideration of alternative combined hormonal methods as first-line options 1. The patch may be particularly appropriate for women who struggle with daily pill compliance but should be avoided in women weighing over 198 pounds due to reduced efficacy 2, 4.