Norelgestromin/Ethinyl Estradiol Transdermal Contraceptive Patch
The norelgestromin/ethinyl estradiol transdermal patch (150 mcg/35 mcg per day) is an appropriate contraceptive option for healthy, non-smoking women under 35, but other combined hormonal methods may be safer first-line choices due to the patch's 1.6-fold higher estrogen exposure and possible increased venous thromboembolism risk compared to standard oral contraceptives. 1
Dosing and Administration
- Apply 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 1
- If started within the first 5 days of menstrual bleeding, no backup contraception is needed 1, 2
- If started >5 days after menstrual bleeding begins, use backup contraception for 7 days 1, 2
Efficacy
- Perfect use failure rate: <1% 1
- Typical use failure rate: 9% 1
- Efficacy is comparable to combined oral contraceptives 1, 3
- Patch detachment requiring replacement occurs in approximately 4.7% of cases (1.8% complete, 2.9% partial) 4, 3
Critical Safety Concerns and Contraindications
Black Box Warning: Venous Thromboembolism Risk
The FDA-mandated black box warning (updated August 2012) cites 5 US studies showing possible increased VTE risk compared to 20-35 mcg oral contraceptives, with odds ratios of 1.2 to 2.2. 1
- The patch delivers 1.6 times higher estrogen exposure than standard oral contraceptives 1
- More recent research confirms VTE risk is approximately twice that of combined oral contraceptives, though absolute risk remains low 5
Absolute Contraindications (Same as Combined Hormonal Contraceptives)
- History of venous thromboembolism or current thrombophilia 2
- Migraine with aura 2
- Uncontrolled hypertension 2
- Active liver disease 2
- Complicated valvular heart disease 2
- Smoking in women ≥35 years old 2
- Breastfeeding women during first 3 weeks postpartum (Category 4) 1, 2
- Breastfeeding women during weeks 4-6 postpartum generally should not use (Category 3) 1
Common Side Effects
- Breast tenderness/discomfort: 22% of patch users vs 6-9% with oral contraceptives 4
- Application site reactions: 17% of users (unique to patch) 4, 5, 3
- Breakthrough bleeding/spotting: more common in first 2 cycles, equalizes by cycle 3 4, 6
- Slightly longer menstrual periods (5.6 days vs 4.7 days with oral contraceptives) 4
- Nausea, headaches, and vaginal discharge (similar rates to oral contraceptives) 3, 6
Adherence Considerations
Advantages
- Self-reported "perfect compliance" significantly better with patch (88.2%) than oral contraceptives (77.7%) 3, 6
- Weekly dosing eliminates daily pill-taking 1
- Compliance rates remain high across age groups, whereas oral contraceptive compliance decreases with younger age 3
Disadvantages
- 1-year continuation rate: only 57% for patch vs 76% for oral contraceptives in adolescents 1
- Higher discontinuation rates due to adverse events (approximately 12% vs 5% with oral contraceptives) 4
- Patch users were more likely to experience pregnancy due to method discontinuation 1
Alternative Contraceptive Options
For women seeking non-daily combined hormonal contraception, consider these alternatives that may offer better safety profiles: 1
- Vaginal contraceptive ring: Lower estrogen exposure (15 mcg ethinyl estradiol daily), monthly insertion, excellent for extended cycling 1
- Combined oral contraceptives: Lower estrogen exposure (20-35 mcg), well-established safety profile 1
- Long-acting reversible contraceptives (LARCs): Progestin IUD or implant offer superior efficacy without estrogen-related VTE risk 1
Clinical Decision Algorithm
For healthy, non-smoking women under 35 requesting non-daily contraception:
- First-line recommendation: Vaginal ring or LARC methods (lower VTE risk, better continuation rates) 1
- Consider patch if: Patient strongly prefers weekly application over monthly ring or daily pill AND has no VTE risk factors 1
- Avoid patch if: Patient has any VTE risk factors, body weight >90 kg (reduced efficacy), or history of poor method continuation 1, 5
Common Pitfalls to Avoid
- Do not prescribe without screening for VTE contraindications, particularly personal or family history of thromboembolism, thrombophilia, or migraine with aura 2
- Do not assume better adherence equals better continuation: Despite higher perfect-use compliance, patch users have lower 1-year continuation rates 1
- Do not dismiss the higher estrogen exposure: Counsel patients that patch delivers 60% more estrogen than standard oral contraceptives 1
- Do not forget proper disposal: Used patches contain significant residual hormones and must be placed in provided sachets and returned to pharmacy 4