Effect of a Low-Dose Contraceptive Patch on Efficacy, Bleeding Pattern, and Safety: A 1-Year, Multicenter, Open-Label, Uncontrolled Study

Abstract

This Phase III, uncontrolled, open-label, multicenter study was conducted to investigate the contraceptive efficacy, bleeding pattern, and cycle control of a novel once-a-week contraceptive patch, delivering low-dose ethinyl estradiol (EE) and gestodene (GSD) at the same systemic exposure seen after oral administration of a combined oral contraceptive containing 0.02 mg EE/0.06 mg GSD. Participants were women aged 18 to 35 years, all of whom received the EE/GSD patch for 13 cycles each of 21 treatment days (one patch per week for 3 weeks) followed by a 7-day, patch-free interval. The primary efficacy variable was the occurrence of unintended pregnancies during the study period as assessed by life table analysis and the Pearl Index. Secondary efficacy variables were days with bleeding during four 90-day reference periods and during 1 treatment year, bleeding pattern, and cycle control. The Kaplan-Meier probability of contraceptive protection after 364 treatment days was 98.8% and the adjusted Pearl Index was 0.81. The percentage of participants with intracyclic bleeding/spotting decreased over time, from 11.4% to 6.8% in cycles 1 and 12, respectively. Almost all participants (range: 90.8%-97.6%) experienced withdrawal bleeding across the study period. Compliance was very high (mean: 97.9%; median: 100%). The most frequent adverse events were headache (9.5%) and application site reaction (8.5%); no clinically significant safety concerns were observed. Results suggest the EE/GSD patch is highly effective in preventing pregnancy. Menstrual bleeding pattern was favorable and within the ranges expected of a healthy female population. The patch was well tolerated and treatment compliance was high.

A comparison of bleeding patterns and cycle control using two transdermal contraceptive systems: a multicenter, open-label, randomized study

“…The findings reported here are in line with those of a phase III study of the contraceptive efficacy of the EE/GSD patch, which found that the Kaplan-Meier probability of contraceptive protection after 364 treatment days was 98.8% and the adjusted Pearl Index was 0.81 [19].…”

“…3 The tolerability of the two patches was otherwise similar. In terms of study limitations, small sample size restricts the extent to which the data can be used to evaluate pregnancy and safety outcomes; although, the aforementioned phase III study provides reassuring data on pregnancy outcomes, as assessed in a larger number of women (n= 1,631) [19]. Despite this, the risk of rare but pertinent events such as venous thromboembolism cannot reasonably be assessed here.…”

Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study

“…In terms of study limitations, the small sample size restricts the extent to which the data can be used to evaluate pregnancy and safety outcomes; however, data from a previous phase III study (n= 1,631) of the EE/GSD patch suggest good contraceptive efficacy, with an adjusted Pearl Index score of 0.81 [19]. Despite this, the risk of rare but pertinent events such as venous thromboembolism cannot reasonably be assessed here.…”

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 a larger phase 3 study of the ethinyl estradiol/ gestodene patch (n ¼ 1631), this percentage was slightly lower, with only 5.7% of patches becoming completely detached. 38 In a pooled analysis of data with a norelgestromin/ethinyl estradiol patch (n ¼ 3319), 1.8% of patches were replaced because of complete detachment. 39 In general, the safety profile of the ethinyl estradiol/ gestodene patch was comparable with that observed with other transdermal contraceptive patches.…”