Trial Condition(s):

Healthy

Investigate impact of Yasmin vs Microgynon on hemostasis parameters in healthy women

Bayer Identifier:

91270

ClinicalTrials.gov Identifier:

NCT00651846

EudraCT Number:

Not Available

Study Completed

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
43
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Yasmin (EE30/DRSP, BAY86-5131)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Dinox GmbH Berlin

Berlin, Germany, 10115

Status
Completed
 

Trial Design