Trial Condition(s):
Contraception
Relative bioavailability, transdermally administered EE and GSD, 3 applications sites
Bayer Identifier:
91608
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Influence of different application sites on the blood levels after administration of a fertility control patch
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Bayer Pharma AG Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open-label, randomized, crossover study to investigate the relative bioavailability of transdermally administered ethinylestradiol (EE) and gestodene (GSD) after repeated applications of a fertility control patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene to 3 different application sites (buttocks, arm versus abdomen) in healthy young female subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
3
Primary Outcome
- AUC(0-168) for EE and Gestodene during week 4 of each treatment periodTimeframe: Week 4 of each treatment period ( 3 periods)
Secondary Outcome
- Pharmacokinetic parameters of EE and GSD: Cmax, Cmin, Cav, tmax, t1/2 obtained during week 4, Ctrough obtained at the end of each weekTimeframe: Week 1-5 of each treatment period
- Adverse EventsTimeframe: Week 1-5 of each treatment period
Additional Information
Copyright © Bayer
Powered by
