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

Bayer43 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Yasmin (DRSP 3mg/EE 0.03 mg)DRUG

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).

Microgynon (LNG 0.15 mg/EE 0.03 mg)DRUG

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).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Unnamed facility

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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