Investigate Impact of Yasmin vs Microgynon on Hemostasis Parameters in Healthy Women

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Drospirenone and ethinyl estradiol combination; Ethinyl Estradiol-Norgestrel Combination; Ethinyl estradiol, levonorgestrel drug combination; Hemostatics

Criteria

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 (
• 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.