We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01731132
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Contraception Drug: Levonorgestrel IUD or Copper IUD

Study Design

Study Type : Observational
Actual Enrollment : 207 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.
Study Start Date : July 2012
Primary Completion Date : February 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1 Drug: Levonorgestrel IUD or Copper IUD
Women who initiate the use of an IUD at the time of the study.


Outcome Measures

Primary Outcome Measures :
  1. Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire. [ Time Frame: After 12 months ]

Secondary Outcome Measures :
  1. Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire. [ Time Frame: Baseline ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who starts contraception with an IUD.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731132


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01731132     History of Changes
Other Study ID Numbers: 16341
MA1213ES ( Other Identifier: Company Internal )
BAY-DIU-2011-01 ( Other Identifier: Company Internal )
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

Keywords provided by Bayer:
HRQoL
IUD
Contraception
SEC-QoL

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral