Multi-center, open-label, randomized, parallel-group comparison of cycle control, bleeding pattern, lipid and carbohydrate metabolism of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen vs. a comparator patch EVRA® (0.6 mg ethinylestradiol and 6 mg norelgestromin) in a 21-day regimen for 7 cycles in 400 women

Transdermally-applied steroid hormones for systemic use have been successfully
used in hormone therapy (HT).
Oral contraceptives (OCs) usually contain ethinylestradiol (EE) in combination
with a progestin. Oral administration of EE is characterized by high intra-
and interindividual pharmacokinetic (PK) variability. Estrogens are known to
be well absorbed through the skin. Moreover, the continuous substance release
from a patch provides more constant serum hormone concentrations. In addition,
a patch may be more convenient than OCs for the user, since it needs to be
replaced only once a week.

To investigate the bleeding pattern and cycle control parameters of the
transdermal contraceptive patch (material no. 80876395, FC Patch Low containing
0.55 mg EE and 2.1 mg GSD) in comparison to the EVRA patch (containing 0.6 mg
EE and 6 mg NGMN).

Multi-center, open-label, randomized, parallel-group comparison of cycle
control, bleeding pattern, lipid and carbohydrate metabolism of the transdermal
contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene
(material no. 80876395) in a 21-day regimen vs. a comparator patch EVRA (0.6 mg
ethinylestradiol and 6 mg norelgestromin) in a 21-day regimen for 7 cycles in
400 women.
All women will be requested to visit the study centre for 7 times.

Volunteers will be randomly assigned (1:1) to either the FC patch low or the
EVRA patch

All volunteers will be requested to come fasted from midnight of the night
before their bloodtests at the screeningvisit (visit 1), the visits during
cycles 3 (visit 3) and 7 (visit 5) and at the last visit (visit 7).
At the screeningvisit, all volunteers will have a physical and gynecological
examination and (unless a normal smear result is available within the last 6
months) a cervical smear sample will be taken. In addition, a urine pregnancy
test will be performed and a home pregnancy test will need to be performed on
the first day of the next menstrual period and if applicable during the study.
All volunteers will have 7 PK bloodsamples taken of which two at visit 4 and
visit 6 with one hour in between.
All volunteers will keep a diary during the trial and will be asked to complete
a questionnaire at the last study visit to evaluate their assessment of the
patch.