NCT00651846

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Jun 2003

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

First QC Date

April 1, 2008

Last Update Submit

December 29, 2014

Conditions

Healthy

Keywords

ContraceptionHemostasisBlood Coagulation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Arm 1

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

Arm 2

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

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).

Arm 1
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).

Arm 2

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically normal safety laboratory results

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, State of Berlin, 10115, Germany

Location

MeSH Terms

Conditions

Thrombosis

Interventions

drospirenone and ethinyl estradiol combinationdrospirenoneethinyl estradiol, levonorgestrel drug combination

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 3, 2008

Study Start

June 1, 2003

Study Completion

February 1, 2005

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

DE(1)