Healthy
Conditions
Keywords
Contraception, Hemostasis, Blood Coagulation
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
Interventions
DRUGYasmin (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).
DRUGMicrogynon (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).
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed