Women's health (London, England) · 2014
Effects of an ethinyl estradiol/gestodene transdermal contraceptive patch on the endometrium: a single-center, uncontrolled study.
Клиническое исследование II фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Merz Martin, Grunert Julia
Аннотация
AIM: This study aims to investigate the effect of a transdermal contraceptive patch containing ethinyl estradiol and gestodene on endometrial proliferation over 1 year.
MATERIALS & METHODS: In this open-label, uncontrolled, Phase IIb study, women (aged 18-35 years) used the patch for 13 cycles of 28 days. The primary variable was histologic endometrial effects at cycle 13. Secondary objectives included contraceptive efficacy and safety.
RESULTS: Overall, 89 women were treated. At all visits, endometrial biopsies were devoid of any abnormalities. One woman became pregnant. The patch was well tolerated, with no safety concerns.
CONCLUSION: The ethinyl estradiol and gestodene patch had an endometrial effect consistent with suppression of endometrial proliferation in most patients. No endometrial abnormalities or other concerns were reported; compliance was good.
MATERIALS & METHODS: In this open-label, uncontrolled, Phase IIb study, women (aged 18-35 years) used the patch for 13 cycles of 28 days. The primary variable was histologic endometrial effects at cycle 13. Secondary objectives included contraceptive efficacy and safety.
RESULTS: Overall, 89 women were treated. At all visits, endometrial biopsies were devoid of any abnormalities. One woman became pregnant. The patch was well tolerated, with no safety concerns.
CONCLUSION: The ethinyl estradiol and gestodene patch had an endometrial effect consistent with suppression of endometrial proliferation in most patients. No endometrial abnormalities or other concerns were reported; compliance was good.