CClinicalTrials.gg
CompletedNCT00883662Updated Sep 30, 2016

Mirena Observational Program

An observational study in Contraception, Menorrhagia and Endometrial Hyperplasia, sponsored by Bayer. Completed at 1 site in Kazakhstan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-30.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,725
Ages
18 Years and older
Sex
Female
01

Study summary

Mirena is used for long-term in Kazakhstan, and in our observational program we would like to study patients distribution per indications of Mirena, and also patient compliance within a year after Mirena insertion. For patients with all approved indications for Mirena use: contraception, treatment of menorrhagia and protection from endometrial hyperplasia during estrogen replacement therapy

02

Conditions studied

  • Contraception
  • Menorrhagia
  • Endometrial Hyperplasia
  • Estrogen Replacement Therapy
03

In context

Menorrhagia

182 studies on the registry are indexed under Menorrhagia; 33 are open to participants now.

This study's enrollment of 2,725 is above the median of 300 across 41 observational studies indexed under Menorrhagia.

Browse Menorrhagia studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

Inclusion criteria

  • Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

Exclusion criteria

Exclusion Criteria:

  • All patients with contraindications to Mirena insertion, according to approved prescribing information.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,725 participants (actual)

Groups and cohorts

  • Group 1

    Drug: Levonorgestrel (Mirena, BAY86-5028)

Interventions

  • DrugLevonorgestrel (Mirena, BAY86-5028)

    Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

06

What researchers measure

Primary outcomes

  1. Patient distribution per indication

    Time frame: 12 months

Secondary outcomes

  1. Patient compliance

    Time frame: 12 months

07

Study locations

1 site
  • Many Locations, Kazakhstan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00883662
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Apr 20, 2009
Start date
May 2009
Primary completion
Apr 2014
Completion
Nov 2015
Last update
Sep 30, 2016

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion