NCT01731132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

1.6 years

First QC Date

September 17, 2012

Last Update Submit

July 15, 2015

Conditions

Contraception

Keywords

HRQoLIUDContraceptionSEC-QoL

Outcome Measures

Primary Outcomes (1)

  • Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.

    After 12 months

Secondary Outcomes (1)

  • Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.

    Baseline

Study Arms (1)

Group 1

Drug: Levonorgestrel IUD or Copper IUD

Interventions

Levonorgestrel IUD or Copper IUDDRUG

Women who initiate the use of an IUD at the time of the study.

Group 1

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women who starts contraception with an IUD.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Spain

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2012

First Posted

November 21, 2012

Study Start

July 1, 2012

Primary Completion

February 1, 2014

Study Completion

July 1, 2014

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

ES(1)