[Safety evaluation of a transdermal contraceptive system with an oral contraceptive].
OBJECTIVE
evaluation of the frequency of adverse events during the therapy with a transdermal contraceptive system (TCS) in comparison to an oral contraceptive.


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.


CONCLUSIONS
The study suggests that a transdermal contraceptive system is a safe and well tolerated therapy.
Radowicki
Stanisław
S
Klinika Endokrynologii Ginekologicznej AM w Warszawie.
Skórzewska
Katarzyna
K
Szlendak
Katarzyna
K
D000279:Administration, Cutaneous; D000284:Administration, Oral; D000328:Adult; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage; D017135:Desogestrel / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005003:Ethisterone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D009644:Norgestrel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010091:Oximes / Q000008:administration & dosage / Q000009:adverse effects; D016387:Women's Health
D003271:Contraceptive Agents, Female; D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; D004338:Drug Combinations; D010091:Oximes; D009644:Norgestrel; D004997:Ethinyl Estradiol; D017135:Desogestrel; D005003:Ethisterone; C449219:norelgestromin