Trial Condition(s):
Healthy
Investigate impact of Yasmin vs Microgynon on hemostasis parameters in healthy women
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 | Status | ||
|---|---|---|---|
Locations Dinox GmbH Berlin Berlin, Germany, 10115 | Status Completed | 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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