check_circleStudy Completed

Contraception

Bayer Identifier:

16341

ClinicalTrials.gov Identifier:

NCT01731132

EudraCT Number:

Not Available

EU CT Number:

Not Available
DIU-QoL. Quality of life evaluation in Intrauterine Device users.

Trial 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.

Key Participants Requirements

Sex

Female

Age

18 - 49 Years
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
207
Trial Dates
July 2012 - July 2014
Phase
N/A
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Spain

Primary Outcome

  • Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.
    date_rangeTime Frame:
    After 12 months
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    Safety Issue:
    No

Secondary Outcome

  • Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.
    date_rangeTime Frame:
    Baseline
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    Safety Issue:
    No

Trial design

DIU-QoL. Quality of life evaluation in Intrauterine Device users.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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