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

Completed

• Conditions: Contraception
• Interventions: Drug: Levonorgestrel IUD or Copper IUD

• Registration Number: NCT01731132
• Lead Sponsor: Bayer

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-11-16
• Study First Posted: 2012-11-21
• Primary Completion: 2014-02
• Study Completion: 2014-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 207

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Levonorgestrel IUD or Copper IUD	-

Primary Outcome Measures

Name	Time	Method
Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.	After 12 months

Secondary Outcome Measures

Name	Time	Method
Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.	Baseline