Trial Condition(s):
Investigate impact of Yasmin vs Microgynon on hemostasis parameters in healthy women
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
- Clinically normal safety laboratory results
- 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.
Locations | Status | ||
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Locations Dinox GmbH Berlin Berlin, Germany, 10115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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