check_circleStudy Completed

Contraception

Bayer Identifier:

91352

ClinicalTrials.gov Identifier:

NCT00624130

EudraCT Number:

Not Available

EU CT Number:

Not Available
Yasmin 20 cycle control - Yasmin 20 versus Mercilon in healthy female volunteers

Trial purpose

The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Healthy female volunteer aged 18-35,
    - Smokers 18-30
  • - Contraindications for using hormonal contraceptives

Trial summary

Enrollment Goal
453
Trial Dates
March 2004 - June 2005
Phase
Phase 3
Could I Receive a placebo
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Väestöliiton Klinikat Oy TurkuTurku, 20101, Finland
Completed
Ylioppilaiden terveydenhoitosäätiö, HelsinkiHelsinki, 00260, Finland
Completed
Geri-Med OyHelsinki, 00100, Finland
Completed
Dr. Bernhard PoetschLeibnitz, 8430, Austria
Completed
Praxis Dr. Doris GruberWien, 1050, Austria
Completed
Praxis Dr. Norman RuthWoergl, 6300, Austria
Completed
G. Karpenko Private ClinicVilnius, 2035, Lithuania
Completed
Public outpatient clinic CentroVilnius, 01118, Lithuania
Completed
UAB Via MedicaKaunas, 3043, Lithuania
Completed
Ylioppilaiden terveydenhoitosäätiö, HelsinkiHelsinki, 00260, Finland
Completed
Tampereen TerveyskeskusTampere, 33200, Finland
Completed
Dr. Sigrid Schmidl-AmannSt. Poelten, 3100, Austria
Completed
Praxis Dr. WolleinMoedling, 2340, Austria
Completed
SATUE Kliinikumi NaistekliinikTartu, 51003, Estonia
Completed
Youth and Women's CentrePaernu, 80010, Estonia
Completed
Medicover Eesti ASTalinn, 10145, Estonia
Completed
VAKK Ltd. A. Kildas Private ClinicKaunas, 3042, Lithuania
Completed
Seimos meicinos centras (Private medical centre)Vilnius, 01118, Lithuania
Completed
Private ClinicHorn, 3580, Austria

Primary Outcome

  • Cycle control and bleeding pattern
    date_rangeTime Frame:
    7 cycles
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Pearl index
    date_rangeTime Frame:
    7 cycles
    enhanced_encryption
    Safety Issue:
    no
  • Laboratory tests
    date_rangeTime Frame:
    Screening
    enhanced_encryption
    Safety Issue:
    yes
  • Adverse Events
    date_rangeTime Frame:
    7 cycles
    enhanced_encryption
    Safety Issue:
    yes
  • General Physical and gynecological examinations
    date_rangeTime Frame:
    Screening
    enhanced_encryption
    Safety Issue:
    yes
  • Vital signs
    date_rangeTime Frame:
    Screening, admission
    enhanced_encryption
    Safety Issue:
    yes
  • Body weight
    date_rangeTime Frame:
    Screening, admission
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Open, randomized, parallel multi-center comparison of cycle control and safety of the oral contraceptive Yasmin 20 in a 24-day regimen vs. Mercilon for 7 cycles in 440 healthy female volunteers
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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