[Safety evaluation of a transdermal contraceptive system with an oral contraceptive].

Abstract

OBJECTIVE: evaluation of the frequency of adverse events during the therapy with a transdermal contraceptive system (TCS) in comparison to an oral contraceptive. MATERIAL AND METHODS: 20 healthy women aged 23.8 +/- 4.1 years without contraindication to steroid hormonal therapy and a history of dermal hypersensitivity to adhesive applications. All patients were treated with either contraceptive patches containing 20 microg ethinyl estradiol (EE) and 150 microg norelgestromin (17-dNGM) or a monophasic oral contraceptive containing 20 microg EE and 150 microg desogestrel during 6 cycles. Safety evaluation was based on the frequency of adverse effects, changes in physical and gynecological examinations. RESULTS: The incidence of most adverse effects was similar between the transdermal and oral contraceptive therapies, except of a higher incidence of breast pain, dysmenorrhoea and application site reactions in the patch group. 50% of patients demonstrated gastro-intestinal complaints in the oral contraceptive group. None of the patients discontinued the hormonal contraceptive therapies due to adverse effects. CONCLUSION: The study suggests that a transdermal contraceptive system is a safe and well tolerated therapy.