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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-007024-26-DE
Enrollment
Unknown
Registered
2009-04-03
Start date
2009-04-27
Completion date
Unknown
Last updated
2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers MedDRA version: 9.1 Level: LLT Classification code 10060346 Term: Transdermal contraception MedDRA version: 9.1 Level: LLT Classification code 10030970 Term: Oral contraception

Interventions

Product Name: FC Patch Low Product Code: material no. 80876395 Pharmaceutical Form: Transdermal patch INN or Proposed INN: Ethinylestradiol CAS Number: 57-63-6 Current Sponsor code: ZK 4944 Concentrat

Sponsors

Bayer Healthcare AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 - prothrombin fragment 1 + 2 - D-dimer—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026