Safety evaluation of a transdermal contraceptive system with an oral contraceptive
Radowicki, S.ła.; Skórzewska, K.; Szlendak, K.
Ginekologia Polska 76(11): 884-889
2005
ISSN/ISBN: 0017-0011 PMID: 16566363 Document Number: 333206
Evaluation of the frequency of adverse events during the therapy with a transdermal contraceptive system (TCS) in comparison to an oral contraceptive. 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. 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. The study suggests that a transdermal contraceptive system is a safe and well tolerated therapy.