DIU-QoL. Quality of Life Evaluation in Intrauterine Devic... | NCT01731132

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

NCT01731132

Sponsor

Bayer

Status

Completed

Last Update Posted

Jul 16, 2015Estimated

Enrollment

207Actual

Phase

Not provided

Conditions

Contraception

Interventions

Levonorgestrel IUD or Copper IUD

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MA1213ES	Other Identifier	Company Internal
BAY-DIU-2011-01	Other Identifier	Company Internal

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Sep 17, 2012

First Submission Date that Met QC Criteria

Nov 16, 2012

First Posted Date

Nov 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2015

Last Update Posted Date

Jul 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

207Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Levonorgestrel IUD or Copper IUD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levonorgestrel IUD or Copper IUD	Drug	Women who initiate the use of an IUD at the time of the study.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.		After 12 months

Secondary Outcomes

Measure	Description	Time Frame
Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.		Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Women who starts contraception with an IUD.

Sampling Method

Non-Probability Sample