Abstract | OBJECTIVE: STUDY DESIGN: 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. RESULTS: 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. CONCLUSION: 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.
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Authors | Andrew M Kaunitz, David F Archer, Daniel R Mishell Jr, Marie Foegh |
Journal | American journal of obstetrics and gynecology
(Am J Obstet Gynecol)
Vol. 212
Issue 3
Pg. 318.e1-8
(Mar 2015)
ISSN: 1097-6868 [Electronic] United States |
PMID | 25220709
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 Elsevier Inc. All rights reserved. |
Chemical References |
- Contraceptives, Oral, Combined
- Contraceptives, Oral, Hormonal
- Drug Combinations
- Ortho Evra
- ethinyl estradiol, levonorgestrel drug combination
- Norgestrel
- Ethinyl Estradiol
- Levonorgestrel
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Topics |
- Adolescent
- Adult
- Contraceptives, Oral, Combined
(administration & dosage, adverse effects)
- Contraceptives, Oral, Hormonal
(administration & dosage, adverse effects)
- Drug Combinations
- Ethinyl Estradiol
(administration & dosage, adverse effects)
- Female
- Humans
- Levonorgestrel
(administration & dosage, adverse effects)
- Norgestrel
(adverse effects, analogs & derivatives)
- Obesity
- Patient Outcome Assessment
- Transdermal Patch
- Young Adult
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