ortho-evra and Obesity

The safety and tolerability of a new low-dose levonorgestrel/ethinyl estradiol (LNG/EE) contraceptive patch was compared with 2 combination oral contraceptives in 2 clinical studies in which approximately 30% of enrolled participants were obese.. Two phase 3, open-label, randomized, parallel-group, multicenter trials compared the LNG/EE contraceptive patch (n = 1579) with combination oral contraceptives (n = 581) in healthy women 17-40 years of age. Combination oral contraceptives were LNG 100 μg per EE 20 μg (combination oral contraceptive 20; n = 375) or LNG 150 μg per EE 30 μg (combination oral contraceptive 30; n = 206). Safety and tolerability data from the 2 trials were evaluated in integrated safety analyses.. Treatment-emergent adverse events of 2% or greater in the LNG/EE contraceptive patch were nasopharyngitis (5.2%), nausea (4.1%), upper respiratory infection (3.5%), headache (3.4%), sinusitis (2.9%), cervical dysplasia (2.3%), and urinary tract infection (2.1%). Including skin reaction-related treatment-emergent adverse events, the proportion of women who experienced any treatment-emergent adverse event was similar among women randomized to the contraceptive patch (47.5%), the combination oral contraceptive 20 (47.4%), or the combination oral contraceptive 30 (46.8%). The incidence of treatment-emergent adverse events was similar in obese vs nonobese participants in all groups. Serious adverse events occurred in less than 1% of participants in any of the treatment groups.. The LNG/EE contraceptive patch and combination oral contraceptives were well tolerated and associated with similar treatment-emergent adverse event incidences in obese and nonobese women.

Topics: Adolescent; Adult; Contraceptives, Oral, Combined; Contraceptives, Oral, Hormonal; Drug Combinations; Ethinyl Estradiol; Female; Humans; Levonorgestrel; Norgestrel; Obesity; Patient Outcome Assessment; Transdermal Patch; Young Adult

Young women under the age of 16 years require special consideration when requesting contraception. Such young women can give voluntary consent, which enables prescription and supply providing that the practitioner has determined that the minor is sufficiently mature to understand the details of the method and its use. All reversible methods may be appropriate but it is necessary to provide information in a form that is fully understood. For women with pre-existing medical conditions including obesity, the benefits and risks of the use of individual methods needs to be weighed against the risks of pregnancy for that woman.

Topics: Adolescent; Adult; Anemia; Breast Diseases; Cardiovascular Diseases; Condoms; Contraception; Contraceptive Agents, Female; Contraindications; Desogestrel; Diabetes Mellitus; Drug Combinations; Drug Implants; Epilepsy; Ethinyl Estradiol; Female; Heart Valve Diseases; Humans; Hypertension; Inflammatory Bowel Diseases; Injections; Intrauterine Devices; Levonorgestrel; Liver Diseases; Lupus Erythematosus, Systemic; Medroxyprogesterone Acetate; Migraine Disorders; Norethindrone; Norgestrel; Obesity; Patient Preference; Pregnancy; Progestins; Stroke; Young Adult

Topics: Contraceptive Agents, Female; Desogestrel; Drug Combinations; Ethinyl Estradiol; Evidence-Based Medicine; Female; Humans; Medroxyprogesterone Acetate; Norgestrel; Obesity; Pregnancy; Pregnancy Rate; Risk Assessment