Status:
COMPLETED
Investigate Impact of Yasmin vs Microgynon on Hemostasis Parameters in Healthy Women
Lead Sponsor:
Bayer
Conditions:
Healthy
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- Clinically normal safety laboratory results
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00651846
Start Date
June 1 2003
End Date
February 1 2005
Last Update
December 30 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Berlin, State of Berlin, Germany, 10115