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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: September 17, 2012
Last updated: March 10, 2014
Last verified: March 2014

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

Condition Intervention
Drug: Levonorgestrel IUD or Copper IUD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire. [ Time Frame: After 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire. [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Levonorgestrel IUD or Copper IUD
Women who initiate the use of an IUD at the time of the study.


Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women who starts contraception with an IUD.


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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731132

Many Locations, Spain
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01731132     History of Changes
Other Study ID Numbers: 16341, MA1213ES, BAY-DIU-2011-01
Study First Received: September 17, 2012
Last Updated: March 10, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Bayer:

Additional relevant MeSH terms:
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on April 15, 2014