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

Tracking Information

First Received Date ^ICMJE

April 1, 2008

Last Updated Date

July 8, 2009

Start Date ^ICMJE

June 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00651846 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00651846

Responsible Party

Bayer Schering Pharma AG, Medical Affairs Therapeutic Area Head

Study ID Numbers ^ICMJE

91270, 307286

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP