FC Patch Low: 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 Gestodene (Material no. 80876395) in a 21-day Regimen as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (0.03mg/0.15mg) in a 21-day Regimen on Hemostatic Parameters in 30 Women Aged 18 182 35 Years Over 3 Treatment Cycles in Each Period

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00933179

Enrollment

Registered

2009-07-07

Start date

2009-06-30

Completion date

2010-09-30

Last updated

2014-11-14

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

Conditions

Contraception

Keywords

Prevention of pregnancy

Brief summary

The aim of the present study is to investigate the effects of the transdermal patch on the parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism in healthy women who require contraception.

Interventions

DRUGGestodene/EE Patch (BAY86-5016)

21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles

DRUGEE/Levonorgestrel (Microgynon, BAY86-4977)

21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy woman requesting contraception * Normal cervical smear not requiring further follow-up * History of regular cyclic menstrual periods * Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods

Exclusion criteria

* Pregnancy or lactation - Obesity (Body Mass Index \[BMI\] \> 30.0 kg/m2) * Any diseases or conditions that can compromise the function of the body systems * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results * Any disease or condition that may worsen under hormonal treatment * Undiagnosed abnormal genital bleeding * Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results

Design outcomes

Primary

Measure	Time frame
Prothrombin fragment 1+2, D-dimer	Screening, visit 3-7

Secondary

Measure	Time frame
Procoagulatory parameters	Screening, visit 3-7
Anticoagulatory parameters	Screening, visit 3-7
Thrombin and Fibrin turnover parameters	Screening, visit 3-7

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026