NCT01590537

Brief Summary

This is local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. For each patient, the treating gynecologist documents demographics, medical data, safety parameters and treatment signs and symptoms at an initial visit and one or two follow-up visit(s).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,348

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

2.5 years

First QC Date

May 2, 2012

Last Update Submit

October 15, 2015

Conditions

Contraception

Keywords

non-interventionalMirenaContraceptionRussian Federation

Outcome Measures

Primary Outcomes (1)

  • User satisfaction of the contraception method with Mirena or Copper IUD

    up to 12 months

Secondary Outcomes (4)

  • Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD

    up to 12 months

  • Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)

    up to 12 months

  • Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)

    up to 12 months

  • Relationship between different parameters and women preferences in choosing Mirena or Cooper IUD as their contraceptive method ( demographic parameters, age group, residence, reproductive history and plans, etc.) using patients questionnaire

    up to 12 months

Study Arms (2)

Group 1

Drug: Levonorgestrel (Mirena, BAY86-5028)

Group 2

Device: Copper IUD

Interventions

Levonorgestrel (Mirena, BAY86-5028)DRUG

intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel

Group 1
Copper IUDDEVICE

Copper device, inserted intrauterine

Group 2

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Females who plan long-term contraception and meet criteria of inclusion and exclusion.

You may qualify if:

  • Women 20-40 years old
  • Parity ≥ 1 child
  • Requesting long-term contraception
  • Written informed consent.

You may not qualify if:

  • in accordance with the current leaflet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Russia

Location

MeSH Terms

Interventions

LevonorgestrelIntrauterine Devices, Copper

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsIntrauterine Devices, MedicatedIntrauterine DevicesContraceptive Devices, FemaleContraceptive DevicesEquipment and Supplies

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 2, 2012

First Posted

May 3, 2012

Study Start

September 1, 2011

Primary Completion

March 1, 2014

Study Completion

October 1, 2014

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations

RU(1)