Effects of an Ethinyl Estradiol/Gestodene Transdermal Contraceptive Patch on the Endometrium: A Single-Center, Uncontrolled Study

Abstract

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.

Pharmacokinetics and adhesion of a transdermal patch containing ethinyl estradiol and gestodene under conditions of heat, humidity, and exercise: A single‐center, open‐label, randomized, crossover study

“…In this study 13 of 36 women were excluded from the pharmacokinetic analysis because of procedure deviations, treatment deviations, and/or intake of concomitant medication not permitted by the study protocol; thus, even though 10–12 subjects were evaluated as planned for the exploratory intraindividual comparison of primary pharmacokinetic parameters for each sporting activity versus SNA, expanding the sample size could potentially limit the impact of such exclusions on the extent of evaluable data while also adding to existing data on tolerability. However, as mentioned, studies with larger numbers of women have supported the tolerability findings reported here . Subsequent studies could also benefit from using real‐time electronic diaries for recording details of patch checks, date and time of patch loss, and also more details on the activity being conducted when the patch became detached.…”

“…A phase 2b openlabel trial of healthy women randomized to receive the ethinyl estradiol/gestodene patch for 13 cycles of 28 days (n ¼ 89) found that a similar percentage of women experienced at least 1 TEAE (89.9%), most of which were mild to moderate in intensity. 40 Furthermore, a phase 3 study of the ethinyl estradiol/gestodene patch in a large sample of women (n ¼ 1631) from 60 centers across a range of countries (Germany, Italy, France, Spain, Chile, Mexico, and Australia) found the patch to be well tolerated with no clinically significant safety concerns being observed. 38 When considered alongside the data reported here, these findings contribute to the overall positive clinical profile of the ethinyl estradiol/gestodene patch.…”

“…However, as mentioned, studies with larger numbers of women have supported the tolerability findings reported here. 40 Subsequent studies could also benefit from using real-time electronic diaries for recording details of patch checks, date and time of patch loss, and also more details on the activity being conducted when the patch became detached. Electronic variants could offer a more discreet way for women to record data, while also being portable and accurate.…”