Investigate Impact of Yasmin vs Microgynon on Hemostasis Parameters in Healthy Women
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Yasmin (DRSP 3mg/EE 0.03 mg) (Drug); Microgynon (LNG 0.15 mg/EE 0.03 mg) (Drug)
Phase: Phase 4
Sponsored by: Bayer
Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study
Pro-coagulatory parameters: Factor VIII (activity), Fibrinogen
Anti-coagulatory parameters: Protein C (activity), Antithrombin III(activity), APC resistance (factor V mutation)
Rosing test: APC sensitivity ratio
Pro-coagulatory parameters: Factor VIII (activity), Activation markers: D-dimer, Prothrombin fragment 1+2
Minimum age: 18 Years.
Maximum age: 35 Years.
- Clinically normal safety laboratory results.
- Standard contraindications for use of combined oral contraceptives (class label).
- 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 and Contacts
Berlin, Berlin / 285 10115, Germany
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Starting date: June 2003
Ending date: February 2005
Last updated: April 4, 2008