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Completed

NCT Number: NCT00651846

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

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

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Key information

Conditions

Healthy Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Berlin, State of Berlin, 10115, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2005
First posted
Apr 3, 2008
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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