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
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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
Clinical Details
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
Primary outcome: Pro-coagulatory parameters: Factor VIII (activity), FibrinogenAnti-coagulatory parameters: Protein C (activity), Antithrombin III(activity), APC resistance (factor V mutation)
Secondary outcome: Rosing test: APC sensitivity ratioPro-coagulatory parameters: Factor VIII (activity), Activation markers: D-dimer, Prothrombin fragment 1+2
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
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 (<= 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
Additional Information
Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product Click here to find results for studies related to marketed products
Starting date: June 2003
Ending date: February 2005
Last updated: April 4, 2008
|
