Trial Condition(s):
Healthy
Investigate impact of Yasmin vs Microgynon on hemostasis parameters in healthy women
Bayer Identifier:
91270
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The objective of this study was to investigate the impact of the oral contraceptive YASMIN (containing: drospirenone 3 mg/ethinyl estradiol 30 mcg) in comparison with the oral contraceptive MICROGYNON (containing: levonorgestrel 150 mcg/ethinyl estradiol 30mcg) on factors of blood coagulation and fibrinolysis in female subjects
Inclusion Criteria
- Clinically normal safety laboratory results
Exclusion Criteria
- Standard contraindications for use of combined oral contraceptives (class label). Including: -- Presence or history of thromboembolic process in veins (such as deep venous thrombosis, pulmonary embolism) or arteries (e.g., stroke, myocardial infarction) or a known genetic component (homozygous), venous thromboembolic event in a close relative (parents or siblings) at younger age (</= 40 years) - Acute and chronic severe liver dysfunction or disease. There should be an interval of at least 6 months between the subsidence of a viral hepatitis (normalization of the liver parameters) and the start of the study medication. - Use of preparations where experience shows affect on the activity of hepatic enzymes.
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
Single center, double blind, randomized, crossover study to investigate the impact of the oral contraceptive Yasmin (30 µg EE / 3 mg DRSP) compared to Microgynon (30 µg / 150 LNG) on hemostasis parameters in 40 female volunteers
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Pro-coagulatory parameters: Factor VIII (activity), FibrinogenTimeframe: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
- Anti-coagulatory parameters: Protein C (activity), Antithrombin III(activity), APC resistance (factor V mutation)Timeframe: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
Secondary Outcome
- Rosing test: APC sensitivity ratioTimeframe: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
- Pro-coagulatory parameters: Factor VIII (activity), Activation markers: D-dimer, Prothrombin fragment 1+2Timeframe: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
Additional Information
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