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

This study is currently recruiting participants.
Verified March 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01731132
First received: September 17, 2012
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Contraception
 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:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

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: March 2014
Estimated 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.

  Eligibility

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.

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

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Hispania S.L
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 7, 2013
Health Authority: Spain: Spanish Agency of Medicines

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
 Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 23, 2013