A single-center, open-label, crossover, randomized study to investigate the impact of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestogene (material no. 80876395) in a 21-day regimen as compared to a monophasic contraceptive containing ethinyestradiol and levonogestrel (0.33 mg/0.15 mg) in a 21-day regimen on hemostatic parameters in 30 women aged 18-35 years over 3 treatment cycles in each period - FC-Patch Metabolism Study

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10060346Term: Transdermal contraception; healthy volunteers; MedDRA version: 9.1Level: LLTClassification code 10030970Term: Oral contraception

• Registration Number: EUCTR2008-007024-26-DE
• Lead Sponsor: Bayer Healthcare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-03
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- signed and dated informed consent
- healthy women requesting contrception
- age:18-35 years (inclusive), Smokers must be not older than 30 years at the time of informed consent
- normal cervical smear not requiring further follow-up
- history of regular cyclic menstrual periods
- willingness to use back-up contraception during the 2 washout cycles

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment)
- obesity (Body Mass Index >30.0 kg/m2)
- hypersensitivity to any ingredient of the study drug
- significant skin reaction to transdermal preparations or sensitivity to medical tape
- safety relevant laboratory values outside inclusion range before start of treatment
- diseases or conditions that can compromise the function of the body systems, may worsen under hormonal treatment or might interfere with the conduct of the study
- undiagnosed abnormal genital bleeding
- abuse of alcohol, drugs or medicines
- any medication that could result in excessive accumulation, impaired metabolism or altered excretion of the study drug or interfere with the contact of the study
- major surgery planned during study period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the impact of the transdermal contraceptive patch in a 21-day regimen on hemostasis parameters in comparison to a combined oral contracetive in a 21-day regimen.;Secondary Objective: Contrceptive efficacy, bleeding pattern, cycle control and safety profile (including cyrbohydrate and lipid metabolism) of the FC-Patch low in comparison with the COC.;Primary end point(s): The primary variable are intraindividual absolute changes from baseline to treatment of the hemostatic parameters<br>- prothrombin fragment 1 + 2<br>- D-dimer