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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Yasmin (DRSP 3mg/EE 0.03 mg); Drug: Microgynon (LNG 0.15 mg/EE 0.03 mg)

• Registration Number: NCT00651846
• Lead Sponsor: Bayer

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 (containing: levonorgestrel 150 mcg/ethinyl estradiol 30mcg) on factors of blood coagulation and fibrinolysis in female subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study Completion: 2005-02
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

• Clinically normal safety laboratory results

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Yasmin (DRSP 3mg/EE 0.03 mg)	-
Arm 2	Microgynon (LNG 0.15 mg/EE 0.03 mg)	-

Primary Outcome Measures

Name	Time	Method
Pro-coagulatory parameters: Factor VIII (activity), Fibrinogen	At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
Anti-coagulatory parameters: Protein C (activity), Antithrombin III(activity), APC resistance (factor V mutation)	At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods

Secondary Outcome Measures

Name	Time	Method
Rosing test: APC sensitivity ratio	At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
Pro-coagulatory parameters: Factor VIII (activity), Activation markers: D-dimer, Prothrombin fragment 1+2	At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods