Efficacy and Safety of a Transdermal Contraceptive System

Smallwood, Geoffrey H; Meador, Mary L.; Lenihan, J M A; Shangold, Gary A.; Fisher, Alan C.; Creasy, George W.

doi:10.1097/00006250-200111000-00016

Cited by 28 publications

(50 citation statements)

References 15 publications

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“…Several methods of steroid contraception, including oral contraceptive pills, progestin-only pills, transdermal contraceptive patches, and the vaginal ring, have been shown to be less effective in obese women (18). A multicenter study of 1,672 healthy ovulatory sexually active women randomized to receive the Ortho-Evra patch for 6 or 13 cycles found a higher rate of failure (pregnancy) in women weighing greater than 90 kg (19). Likewise, a study of 1,005 women using the Levonorgestrel vaginal ring revealed higher pregnancy rates with higher body weights.…”

Section: Results Epidemiologymentioning

confidence: 99%

Impact of obesity on women's health

Lash

Armstrong

2009

Fertility and Sterility

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Section: Results Epidemiologymentioning

confidence: 99%

Impact of obesity on women's health

Lash

Armstrong

2009

Fertility and Sterility

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“…37 Obesity is a risk factor for technical failure of tubal ligation surgery (OR, 1.7; 95% CI, 1.2-2.6). 40 The intrauterine device may be one of the few reliable contraception options whose efficacy does not seem to be affected by BMI. 37 Product inserts rarely comment on weight-specific guidelines (Table 4).…”

Section: Obesity and Infertility (Including Polycystic Ovary Syndrome)mentioning

confidence: 99%

Obesity and Women's Health: An Evidence-Based Review

Kulie¹,

Slattengren²,

Redmer³

et al. 2011

The Journal of the American Board of Family Medicine

264

181

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Obesity negatively impacts the health of women in many ways. Being overweight or obese increases the relative risk of diabetes and coronary artery disease in women. Women who are obese have a higher risk of low back pain and knee osteoarthritis. Obesity negatively affects both contraception and fertility as well. Maternal obesity is linked with higher rates of cesarean section as well as higher rates of highrisk obstetrical conditions such as diabetes and hypertension. Pregnancy outcomes are negatively affected by maternal obesity (increased risk of neonatal mortality and malformations). Maternal obesity is associated with a decreased intention to breastfeed, decreased initiation of breastfeeding, and decreased duration of breastfeeding. There seems to be an association between obesity and depression in women, though cultural factors may influence this association. Obese women are at higher risk for multiple cancers, including endometrial cancer, cervical cancer, breast cancer, and perhaps ovarian cancer. The prevalence of obesity is rising. The World Health Organization estimates that more than 1 billion people are overweight, with 300 million meeting the criteria for obesity. 1 Twenty-six percent of nonpregnant women ages 20 to 39 are overweight and 29% are obese. 2 This article will review the wide-ranging effects that obesity has on both reproductive health and chronic medical conditions in women.A PubMed search was performed using the key words "obesity," "overweight," "body mass index" (BMI), "gender," "women's health," and the condition reviewed. The most recent evidence-based articles were included in the review. The evidence level of each article was determined by the authors based on the type of study, randomization, the number of participants, and loss to follow-up. Table 1 provides a classification for overweight and obesity based on BMI. 3 Waist circumference can also be used to classify overweight and obesity. In women, a waist circumference of Ͼ35 inches (88 cm) is high risk, whereas in men the level is Ͼ40 inches (102 cm). Research varies in the measurements of obesity used to classify participants in each study. Obesity and Type 2 Diabetes MellitusThe risk of diabetes mellitus (DM) increases with the degree and duration of being overweight or obese and with a more central or visceral distribution of body fat. Increased visceral fat enhances the degree of insulin resistance associated with obesity. 4 In turn, insulin resistance and increased visceral fat are the hallmarks of metabolic syndrome, an assembly of risk factors for developing diabetes and cardiovascular disease. 4 -6 The Nurses' Health Study followed 84,000 female nurses for 16 years and found that being overweight or obese was the single most important predictor of DM. 7 An increased risk of DM was seen in women with BMI values Ͼ24 and a waistto-hip ratio Ͼ0.76. 8 After adjusting for age, family history of diabetes, smoking, exercise, and several This article was externally peer reviewed.

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“…This is consistent with the complete detachment rate of less than 2% reported in previous studies of up to 13 cycles' duration involving more than 3000 Ortho Evra™ users. [17][18][19] Ortho Evra™ is a new delivery method of combination hormonal contraception that has demonstrated efficacy and safety comparable to combination oral contraceptives. 17,19 Compliance with the dosing schedule of Ortho Evra™ was shown to be better than compliance with the daily dosing regimen of combination oral contraceptives.…”

Section: Norelgestromin and Ethinyl Estradiolmentioning

confidence: 99%

Pharmacokinetics of Norelgestromin and Ethinyl Estradiol Delivered by a Contraceptive Patch (Ortho Evra™/Evra™) under Conditions of Heat, Humidity, and Exercise

Abrams

Skee

Natarajan

et al. 2001

The Journal of Clinical Pharma

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The objectives of this randomized, open‐label, three‐period, incomplete block design study were to evaluate the pharmacokinetics of norelgestromin (NGMN) and ethinyl estradiol (EE) delivered by the contraceptive patch, Ortho EvraTM/EvraTM, and to evaluate patch adhesion under conditions of heat, humidity, and exercise. During each treatment period, 30 healthy women wore Ortho EvraTM on the abdomen for 7 days under one of six conditions (normal activity, sauna, whirlpool, treadmill, cool water immersion, ora combination of activities). Blood samples were collected before and several times to 240 hours after patch application. Mean serum concentrations of NGMN and EE generally remained within the reference ranges, 0.6 to 1.2 ng/ml and 25 to 75 pg/ml, respectively, duringthe 7‐day wear period for all activities. Only 1 (1.1%) of 87 patches completely detached spontaneously. Peel force measurements were comparable for all activities. Ortho EvraTM was well tolerated. In conclusion, Ortho EvraTM delivers efficacious concentrations of NGMN and EE and maintains adhesive reliability through 7 days of wear even under conditions of heat, humidity, and exercise.

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Efficacy and Safety of a Transdermal Contraceptive System

Cited by 28 publications

References 15 publications

Impact of obesity on women's health

Impact of obesity on women's health

Obesity and Women's Health: An Evidence-Based Review

Pharmacokinetics of Norelgestromin and Ethinyl Estradiol Delivered by a Contraceptive Patch (Ortho Evra™/Evra™) under Conditions of Heat, Humidity, and Exercise

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