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pubmed:abstractText |
Orlistat, a potent and selective inhibitor of gastrointestinal lipases, is designed for the treatment of obesity. A double-blind, randomised, placebo-controlled, 2-way crossover study investigated the possible influence of orlistat on the ovulation-suppressing action of combination oral contraceptives (OC).
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pubmed:otherAbstract |
PIP: In the Netherlands, a double-blind, randomized, placebo-controlled, two-way crossover study was conducted to determine whether administration of the inhibitor of gastrointestinal lipases, Orlistat, concomitantly with combined oral contraceptives (OCs) inhibits the ovulation-suppressing action of OCs. The 20 subjects, 20-27 years old, were healthy and had a body mass index between 22 and 27 kg m-2. All subjects completed the study. Most adverse events were mild and related to the pharmacological effect of Orlistat (fatty or oily stool, flatus with discharge, or abdominal pain). The geometric means of time-averaged serum concentrations in the cycles with Orlistat and the placebo and the 1-sided 95% confidence region for the mean in the cycle with Orlistat were 0.147, 0.145, and less than 0.176 mcg l-1 for progesterone and 1.92, 2.03, and less than 2.23 IU l-1 for luteinizing hormone (LH), respectively. These figures were well below the peak concentrations during normal ovulation (3 mcg l-1 for progesterone and 30 IU l-1 for LH). The plasma concentration of Orlistat was either close to the limit of quantification (1 mcg l-1) or below this limit. These findings suggest that Orlistat had no effect on the ovulation-suppression capabilities of the OCs.
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