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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Yasmin (DRSP 3mg/EE 0.03 mg)
* Drug: Microgynon (LNG 0.15 mg/EE 0.03 mg)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Yasmin (DRSP 3mg/EE 0.03 mg)<br>* 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).<br>|
| Active Comparator: Arm 2<br> | Drug: Microgynon (LNG 0.15 mg/EE 0.03 mg)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Hemostasis, Blood Coagulation