Trial Condition(s):
Contraception
FC Patch low: Metabolism Study
Bayer Identifier:
91557
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Dinox GmbH Berlin Berlin, Germany, 10115 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Prothrombin fragment 1+2, D-dimerTimeframe: Screening, visit 3-7
Secondary Outcome
- Procoagulatory parametersTimeframe: Screening, visit 3-7
- Anticoagulatory parametersTimeframe: Screening, visit 3-7
- Thrombin and Fibrin turnover parametersTimeframe: Screening, visit 3-7
Additional Information
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