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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: Yasmin (DRSP 3mg/EE 0.03 mg)
  • The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack. Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (3mg DRSP/0.03 mgEE). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle).
• Drug: Microgynon (LNG 0.15 mg/EE 0.03 mg)
  • The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack. Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (LNG 0.15 mg/EE 0.03 mg). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • n/a
• Active Comparator: Arm 2
  • n/a

Primary Measures

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

Secondary Measures

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

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651846

Study ID Number: 91270

ClinicalTrials.gov Identifier: NCT00651846

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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