- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731132
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
Intervention / Treatment
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
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Many Locations, Spain
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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
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Women who initiate the use of an IUD at the time of the study.
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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
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After 12 months
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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
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Baseline
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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
Keywords
Additional Relevant MeSH Terms
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.
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