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

Contraception Clinical Trial

— DIUQoL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731132
• Other study ID #: 16341
• Secondary ID: MA1213ESBAY-DIU-
• Status: Completed
• Phase: N/A
• First received: September 17, 2012
• Last updated: July 15, 2015
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: July 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Levonorgestrel IUD or Copper IUD
Women who initiate the use of an IUD at the time of the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.		After 12 months	No
Secondary	Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.		Baseline	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here and search for websynopsis results posting provided by Bayer.