check_circleStudy 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
  • - 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

  • - 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
30
Trial Dates
June 2009 - September 2010
Phase
Phase 2
Could I Receive a placebo
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Dinox GmbH BerlinBerlin, 10115, Germany

Primary Outcome

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

Secondary Outcome

  • Procoagulatory parameters
    date_rangeTime Frame:
    Screening, visit 3-7
    enhanced_encryption
    Safety Issue:
    yes
  • Anticoagulatory parameters
    date_rangeTime Frame:
    Screening, visit 3-7
    enhanced_encryption
    Safety Issue:
    yes
  • Thrombin and Fibrin turnover parameters
    date_rangeTime Frame:
    Screening, visit 3-7
    enhanced_encryption
    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
2

Additional Information

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