Contraception
Conditions
Keywords
Pharmacokinetics
Brief summary
Influence of different application sites on the blood levels after administration of a fertility control patch
Interventions
Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Healthy female subjects * Age 18-45 years * Body mass index (BMI) 18-30kg/m² * At least 3 months since delivery, abortion, or lactation before the first screening examination * Ability to understand and follow study-related instructions * Willingness to accept the synchronizing cycle and to use non-hormonal methods of contraception after starting the synchronizing cycle and during the treatment periods
Exclusion criteria
* Contra-indications for use of combined (estrogen/progestin) contraceptives (e.g. history of venous/arterial disease, liver disorders, migraine) * Skin diseases with suspected alteration of dermal resorption and /or increased risk for dermal intolerance * Regular use of medicines other than contraceptives * Smokers (at the age of 31 to 45 years) * Clinically relevant findings (e.g. blood pressure, physical and gynecological examination, laboratory examination)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(0-168) for EE and Gestodene during week 4 of each treatment period | Week 4 of each treatment period ( 3 periods) |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each week | Week 1-5 of each treatment period |
| Adverse Events | Week 1-5 of each treatment period |
Countries
Germany
Outcome results
None listed