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

NCT ID: NCT01731132

Last Updated: 2015-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

Brief Summary

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Knowledge about the impact on quality of life of women initiating IUD in the Spanish population at baseline and after 12 months of use.

Detailed Description

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Conditions

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Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Levonorgestrel IUD or Copper IUD

Intervention Type DRUG

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

Interventions

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Levonorgestrel IUD or Copper IUD

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Spain

Site Status

Countries

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Spain

Other Identifiers

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MA1213ES

Identifier Type: OTHER

Identifier Source: secondary_id

BAY-DIU-2011-01

Identifier Type: OTHER

Identifier Source: secondary_id

16341

Identifier Type: -

Identifier Source: org_study_id

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