Combined ethinylestradiol/gestodene contraceptive patch: two-center, open-label study of ovulation inhibition, acceptability and safety over two cycles in female volunteers.
OBJECTIVE
Determination of the ovulation inhibition efficacy of a new, transparent, transdermal, combined hormonal contraceptive patch (area 10 cm2) containing 0.9 mg ethinylestradiol and 1.9 mg gestodene in an open-label study of healthy, female volunteers (aged 18-35 years).


METHODS
A total of 199 volunteers from two centers were requested to use the contraceptive patch (one patch/week for 3 weeks, followed by 1 week of no treatment), throughout two menstrual cycles. Ovarian activity was monitored by transvaginal ultrasonography and serum hormone determinations, and classified according to the Hoogland score.


RESULTS
Ovulation inhibition was achieved in all participants (Hoogland score < 6). Secondary efficacy measures, including suppression of serum concentrations of estradiol and progesterone, and of the mid-cycle luteinizing hormone surge, confirmed ovulation inhibition. Ovulation returned in 85.7% of participants during the first cycle after cessation of treatment. There were no abnormal changes in safety parameters. A large majority of users rated the contraceptive patch as 'very convenient'.


CONCLUSIONS
This study showed that the new, combined ethinylestradiol/gestodene contraceptive patch was highly effective in reversibly inhibiting ovulation, well tolerated and regarded as 'very convenient' by the majority of users. This new, transparent, transdermal matrix patch is an attractive alternative form of contraception.
Heger-Mahn
D
D
Dinox GmbH, Berlin, Germany.
Warlimont
C
C
Faustmann
T
T
Gerlinger
C
C
Klipping
C
C
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D003270:Contraceptive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004997:Ethinyl Estradiol / Q000008:administration & dosage; D005260:Female; D005858:Germany; D006801:Humans; D008597:Menstrual Cycle; D009426:Netherlands; D009652:Norpregnenes / Q000008:administration & dosage; D034445:Ovulation Inhibition / Q000187:drug effects; D010349:Patient Compliance; D012449:Safety; D016896:Treatment Outcome
D003270:Contraceptive Agents; D009652:Norpregnenes; C033273:Gestodene; D004997:Ethinyl Estradiol