Assess Satisfaction of Patients and Physicians With Results of Yaz Plus Treatment for 13 Cycles

August 8, 2017 updated by: Bayer

A Prospective Multicenter Non-interventional Study on Patients and Physicians Satisfaction of Yaz Plus

Local prospective multicenter non-comparative non-interventional observational study. It's planed to assess satisfaction of patients and physicians with results of Yaz Plus treatment for 13 cycles in real practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Non-interventional, Yaz Plus, Contraception, Assess satisfaction, Russian Federation.

Study Type

Observational

Enrollment (Actual)

1500

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients ≥ 18 years old requiring contraception, treated with Yaz Plus for the first time and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.

Description

Inclusion Criteria:

  • Female patients ≥ 18 years old
  • Requiring contraception
  • Prescribed with Yaz Plus for the first time

Exclusion Criteria:

  • Contraindications for the use of Yaz Plus in accordance with the local product information

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
Cohort 1
Female patients ≥ 18 years old requiring contraception.
Drug: BAY98-7071_EE20/DRSP/L-5-MTHF
Patients treated by Physicians under approved local prescriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Satisfaction measured with a Likert response scale (from 1 - poor to 5 - excellent)
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: Up to 12 months
Up to 12 months
Changes in EVAPIL scale for assessment of tolerability of oral contraceptives.
Time Frame: Baseline to 12 months
Baseline to 12 months

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 (Actual)

July 15, 2014

Primary Completion (Actual)

August 14, 2016

Study Completion (Actual)

August 14, 2016

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (Estimate)

June 9, 2014

Study Record Updates

Last Update Posted (Actual)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17177
  • YZ1410RU (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.

Clinical Trials on Contraception

Clinical Trials on BAY98-7071_EE20/DRSP/L-5-MTHF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe