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


METHODS
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.


CONCLUSIONS
The lipid changes seen with the contraceptive patch are consistent with those of oral contraceptives containing norgestimate and ethinyl estradiol.
Creasy
George W
GW
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., 920 Route 202, P.O. Box 300, Raritan, NJ 08869, USA. gcreasy@prdus.jnj.com
Fisher
Alan C
AC
Hall
Nancy
N
Shangold
Gary A
GA
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D001835:Body Weight / Q000187:drug effects; D002784:Cholesterol / Q000097:blood*; D008076:Cholesterol, HDL / Q000097:blood* / Q000187:drug effects*; D008078:Cholesterol, LDL / Q000097:blood* / Q000187:drug effects*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D005003:Ethisterone / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D008875:Middle Aged; D009644:Norgestrel / Q000031:analogs & derivatives; D010091:Oximes; D012016:Reference Values; D013997:Time Factors; D014280:Triglycerides / Q000097:blood*
D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D010091:Oximes; D014280:Triglycerides; D009644:Norgestrel; D004997:Ethinyl Estradiol; D002784:Cholesterol; D005003:Ethisterone; C449219:norelgestromin