Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers

December 30, 2014 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

453

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Horn, Austria, 3580
      • Leibnitz, Austria, 8430
      • Moedling, Austria, 2340
      • St. Poelten, Austria, 3100
      • Wien, Austria, 1050
      • Woergl, Austria, 6300
  • Estonia
      • Paernu, Estonia, 80010
      • Talinn, Estonia, 10145
      • Tartu, Estonia, 51003
  • Finland
      • Helsinki, Finland, 00260
      • Helsinki, Finland, 00100
      • Tampere, Finland, 33200
      • Turku, Finland, 20101
  • Lithuania
      • Kaunas, Lithuania, 3042
      • Kaunas, Lithuania, 3043
      • Vilnius, Lithuania, 01118
      • Vilnius, Lithuania, 2035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy female volunteer aged 18-35,
  • Smokers 18-30

Exclusion Criteria:

  • Contraindications for using hormonal contraceptives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: Mercilon
Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)
Experimental: Arm 1
Drug: Yasmin 20
Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cycle control and bleeding pattern
Time Frame: 7 cycles
7 cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
Pearl index
Time Frame: 7 cycles
7 cycles
Laboratory tests
Time Frame: Screening
Screening
Adverse Events
Time Frame: 7 cycles
7 cycles
General Physical and gynecological examinations
Time Frame: Screening
Screening
Vital signs
Time Frame: Screening, admission
Screening, admission
Body weight
Time Frame: Screening, admission
Screening, admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

February 18, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91352
  • 308020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraception

Clinical Trials on Yasmin 20

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe