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OpenTrials
Completed

NCT Number: NCT01731132

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

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

Completed

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Key information

Conditions

Contraception

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levonorgestrel IUD or Copper IUD

Drug

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

Primary outcomes

  1. Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.

    Time frame: After 12 months

Secondary outcomes

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

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: DIUQoL

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 21, 2012
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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