Satisfaction and compliance of 1333 users of transdermal contraception in private gynaecological practice in Austria

Satisfaction and compliance of 1333 users of transdermal contraception in

private gynaecological practice in Austria

C.J. Gruber, D.M. Grube

Department of Gynaecological Endocrinology and Reproductive Medicine,

University of Vienna Medical School, Austria

Objectives: EVRA® transdermal contraceptive patch was approved in

Austria in April 2003. Although extensive data has been obtained from large

clinical trials, information on satisfaction, compliance, adherence and

tolerance in a non-clinical trial population in Europe is limited. Objective of

this study was to evaluate satisfaction, compliance, patch adherence and

tolerability in women prescribed EVRA® over 3 consecutive, 4-week cycles.

Design and Methods: Open, non-interventional study in volunteer women

requiring hormonal contraception. An interim analysis of data from 1333 women

was performed using descriptive statistical methods.

Results: Between July and September 2003 more then 3000 women were

included from private gynaecological practices across Austria. The mean (+SD)

age was 27.2+7.6 years and the mean weight was 61.4+10.3 kg. 75.4%

of the women had previous experience with oral contraceptives. Only 8.9% had no

previous experience with contraceptive methods. 93% of women changed the patch

as instructed in the package insert during the first therapy cycle, and 95%

during the third cycle. Excellent skin adhesion was reported for 94.2% of the

patches during cycle 1 and 95.1% of the patches during cycle 3. 89.3% of women

rated contraception with EVRA® as highly convenient or convenient compared to

their previous contraceptive method. 86% of women and 92% of gynaecologists were

highly satisfied or satisfied with the usage of EVRA® by their patients. At the

time of interim analysis of 1333 users, no pregnancies were reported. EVRA® was

generally well tolerated ; no serious adverse events were reported . The most

common side effects during the first cycle were skin reactions at the

application site (7.0%), breakthrough bleeding or spotting (7.0%), breast

symptoms (3.3%), nausea and vomiting (3.2%) and headache (3.2%). After three

cycles, less side effects were reported with 4.9% of women reporting application-

site related skin reactions, 6.1% breakthrough bleeding or spotting, 3.1% breast

tension, 1.9% headache and 1.7% nausea and vomiting.

Conclusions: The use of EVRA®, a once – weekly contraceptive patch,

showed high compliance, satisfaction and good tolerability in Austrian women

treated in private practice. Adhesion of the contraceptive patch to the skin was

very good.

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