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

Bayer

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Microgynon (LNG 0.15 mg/EE 0.03 mg); Drug: Yasmin (DRSP 3mg/EE 0.03 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651846

307286

91270

Details and patient eligibility

About

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

Enrollment: 43 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Yasmin (DRSP 3mg/EE 0.03 mg)

Arm 2

Active Comparator group

Treatment:

Drug: Microgynon (LNG 0.15 mg/EE 0.03 mg)