The effect of olestra on systemic levels of oral contraceptives.
The effect of olestra, a nonabsorbable, noncaloric fat replacement, on the absorption and efficacy of a highly lipophilic oral contraceptive was investigated in a double-blind, placebo-controlled crossover study with 28 women. Subjects consumed 18 gm/day olestra for 28 days while taking an oral contraceptive containing 300 micrograms of norgestrel and 30 micrograms ethinyl estradiol (Lo/Ovral-28). Blood taken on days 12 to 14 of the treatment cycles was analyzed for ethinyl estradiol and norgestrel. There was no statistically significant difference in time to attain maximum concentration, maximum concentration, or area under the concentration-time curve between the olestra and placebo treatments for either drug component. Measurements of serum progesterone indicated that olestra ingestion did not reduce efficacy as indicated by ovulation. The data show that ingestion of 18 gm/day olestra did not affect the absorption or efficacy of the highly lipophilic oral contraceptive.
Procter and Gamble Company, Winton Hill Technical Center, Cincinnati, OH 45224.
K W
KW
Miller
D S
DS
Williams
S B
SB
Carter
M B
MB
Jones
D R
DR
Mishell
D000328:Adult; D001682:Biological Availability; D003278:Contraceptives, Oral, Hormonal / Q000097:blood / Q000493:pharmacokinetics*; D004042:Dietary Fats, Unsaturated / Q000494:pharmacology*; D004311:Double-Blind Method; D004997:Ethinyl Estradiol / Q000097:blood / Q000493:pharmacokinetics*; D019304:Ethinyl Estradiol-Norgestrel Combination; D005227:Fatty Acids; D005260:Female; D006801:Humans; D009644:Norgestrel / Q000097:blood / Q000493:pharmacokinetics*; D010349:Patient Compliance; D011374:Progesterone / Q000097:blood; D016032:Randomized Controlled Trials as Topic; D013395:Sucrose / Q000031:analogs & derivatives* / Q000494:pharmacology
D003278:Contraceptives, Oral, Hormonal; D004042:Dietary Fats, Unsaturated; D005227:Fatty Acids; D009644:Norgestrel; D004997:Ethinyl Estradiol; D011374:Progesterone; D013395:Sucrose; C013692:sucrose polyester; D019304:Ethinyl Estradiol-Norgestrel Combination