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.
