To Evaluate Compliance to Treatment Regimen (Rate of Deviations From the Prescribed Regimen) in Polish Females Treated With Different Low Dose Oral Contraceptives (DOC)

October 31, 2011 updated by: Bayer

Prospective, Open-label Observational Survey Evaluating Patients Compliance to Administration Regimen During Low Dose Combined Oral Contraceptive Use in Everyday Praxis Data on Oral Contraceptives Compliance - DOC Study

Adherence to the dosing scheme is the principal element of Combined Oral Contraceptives efficiency. On the other hand noncompliance seemed to be an inseparable element of any oral treatment. The aim of the study is to evaluate in everyday practice the relation between dosage errors and indicated factors, potentially influencing the compliance with the dosing scheme.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11884

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

  • Poland
      • Many Locations, Poland

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Gynecological practices patients - starters or current users.

Description

Inclusion Criteria:

  • Patients at the age of over 18 requiring contraception. The decisions would be made at the discretion of the attending physician.

Exclusion Criteria:

  • According to official Summary of Product Characteristics (SmPC) contraindications.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: EE/DRSP (Yasmin Product Family)
One tablet per day, orally, 21 tablets followed by 7 days, during three consecutive cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of users showing noncompliant behaviors
Time Frame: 3 consecutive cycles
3 consecutive cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
The characteristics of noncompliant behavior
Time Frame: 3 consecutive cycles
3 consecutive cycles
The relation between noncompliant behavior and selected factors
Time Frame: 3 consecutive cycles
3 consecutive cycles

Collaborators and Investigators

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

Sponsor

Bayer

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

December 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2011

Last Update Submitted That Met QC Criteria

October 31, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14340
  • YA0712PL (Other Identifier: Company Internal)

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.

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