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Transdermal contraceptive patch delivering norelgestromin and ethinyl estradiol. Effects on the lipid profile.

Author(s): Creasy GW, Fisher AC, Hall N, Shangold GA

Affiliation(s): Johnson & Johnson Pharmaceutical Research & Development, L.L.C., 920 Route 202, P.O. Box 300, Raritan, NJ 08869, USA. gcreasy@prdus.jnj.com

Publication date & source: 2003-03, J Reprod Med., 48(3):179-86.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

OBJECTIVE: To evaluate the metabolic impact on lipids of a contraceptive patch that delivers norelgestromin (primary active metabolite of norgestimate) and ethinyl estradiol to the systemic circulation as compared with a placebo patch. STUDY DESIGN: In this randomized, double-blind trial, healthy women received the contraceptive patch (n = 99) or placebo patch (n = 47) for up to 9 cycles. Fasting blood samples were obtained at baseline and cycles 3, 6 and 9 for determining the serum lipid profile. RESULTS: At cycles 3, 6 and 9, mean increases from baseline in high-density lipoprotein (HDL) cholesterol, HDL3 cholesterol, total cholesterol and total triglycerides, and mean decreases in calculated (Friedewald) low-density lipoprotein (LDL)/HDL were observed in the contraceptive patch group (all P < .05 vs. placebo except for total cholesterol at cycle 6). Mean changes in HDL2 and calculated LDL cholesterol were minimal and comparable between treatments. Mean body weight increased from baseline to the end of treatment by 0.8 and 0.6 kg in the 2 groups, respectively; this difference was not significant. CONCLUSION: The lipid changes seen with the contraceptive patch are consistent with those of oral contraceptives containing norgestimate and ethinyl estradiol.

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