DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users. (DIUQoL)

July 15, 2015 updated by: Bayer
Knowledge about the impact on quality of life of women initiating IUD in the Spanish population at baseline and after 12 months of use.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

207

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

      • Many Locations, Spain

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 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who starts contraception with an IUD.

Description

Inclusion Criteria:

  • 18-49 years old female.
  • Women who is visited by a gynecology or primary care physician and starts contraception with an IUD/IUS.
  • Women that has not used hormonal contraception in any form in the last 3 months.
  • Women who have no problems listening, reading or writing.
  • Women who gives their written consent to participate in the study.

Exclusion Criteria:

  • Women who have contraindications to use IUDs.
  • Women with previous experience with IUDs.
  • Women who initiates the use of IUDs for other purposes other than contraception.
  • Woman who is participating in a clinical trial at the time of initiating the study.

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
Women who initiate the use of an IUD at the time of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.
Time Frame: After 12 months
After 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

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

July 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

November 16, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

July 16, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 16341
  • MA1213ES (Other Identifier: Company Internal)
  • BAY-DIU-2011-01 (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 Levonorgestrel IUD or Copper IUD

3
Subscribe