Study Completed

Contraception

Bayer Identifier:

91557

ClinicalTrials.gov Identifier:

NCT00933179

EudraCT Number:

2008-007024-26

EU CT Number:

Not Available

FC Patch low: Metabolism Study

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years

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

Trial summary

Enrollment Goal

Trial Dates

June 2009 - September 2010

Phase

Phase 2

Could I Receive a placebo

Products

Gestodene/EE Patch (BAY86-5016)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Dinox GmbH Berlin	Berlin, 10115, Germany

Primary Outcome

Prothrombin fragment 1+2, D-dimer
Time Frame:
Screening, visit 3-7
Safety Issue:
yes

Secondary Outcome

Procoagulatory parameters
Time Frame:
Screening, visit 3-7
Safety Issue:
yes
Anticoagulatory parameters
Time Frame:
Screening, visit 3-7
Safety Issue:
yes
Thrombin and Fibrin turnover parameters
Time Frame:
Screening, visit 3-7
Safety Issue:
yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Prevention

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

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