check_circleStudy Completed

Healthy

Bayer Identifier:
91270
ClinicalTrials.gov Identifier:
NCT00651846
EudraCT Number:
Not Available
EU CT Number:
Not Available
Investigate impact of Yasmin vs Microgynon on hemostasis parameters in healthy women

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

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Clinically normal safety laboratory results
  • - 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.

Trial summary

Enrollment Goal
43
Trial Dates
June 2003 - February 2005
Phase
Phase 4
Could I Receive a placebo
No
Products
Yasmin (EE30/DRSP, BAY86-5131)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Dinox GmbH BerlinBerlin, 10115, Germany

Primary Outcome

  • Pro-coagulatory parameters: Factor VIII (activity), Fibrinogen
    date_rangeTime Frame:
    At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
    enhanced_encryption
    Safety Issue:
    no
  • Anti-coagulatory parameters: Protein C (activity), Antithrombin III(activity), APC resistance (factor V mutation)
    date_rangeTime Frame:
    At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Rosing test: APC sensitivity ratio
    date_rangeTime Frame:
    At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
    enhanced_encryption
    Safety Issue:
    no
  • Pro-coagulatory parameters: Factor VIII (activity), Activation markers: D-dimer, Prothrombin fragment 1+2
    date_rangeTime Frame:
    At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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