NCT00868153

Brief Summary

This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
1,125

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 for all trials

Geographic Reach
13 countries

13 active sites

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

August 1, 2004

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

4.3 years

First QC Date

March 23, 2009

Last Update Submit

February 16, 2015

Conditions

Idiopathic Menorrhagia

Outcome Measures

Primary Outcomes (1)

  • To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena

    At vist 1 and 4

Secondary Outcomes (5)

  • Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study

    Every visit

  • The health-related quality of life questionnaire SF-36 at Visits 1 and 4

    Visit 1 and 4

  • The user satisfaction as recorded at Visit 4

    visit 4

  • Adverse reactions recorded in an ongoing way throughout the duration of the study

    every visit

  • Laboratory parameters as measured at Visits 1 and 4

    visit 1 and 4

Study Arms (1)

Group 1

Drug: Levonorgestrel IUS (Mirena , BAY86-5028)

Interventions

Levonorgestrel IUS (Mirena , BAY86-5028)DRUG

One group

Group 1

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women diagnosed with idiopathic menorrhagia, age 30-45, BMI 18-34

You may qualify if:

  • Woman diagnosed with idiopathic Menorrhagia according to assessment of the investigator and according to international guidelines. These woman should also accept to be on contraception during the time period that they have Mirena in situ.
  • Age limit 30-45
  • BMI= 18-34
  • Signed informed consent

You may not qualify if:

  • Medical conditions featured in the Mirena data sheet (See Appendix 1) that contraindicate its use, listed below:
  • Known or suspected pregnancy; current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product.
  • Nulliparity
  • Consumption of Iron, Antiprostaglandins, hormonal drugs and any medication that could effect bleeding should be stopped at least 3 months before the first visit and should not be used during the course of the study.
  • History of diabetes mellitus,cardiovascular disease and thyroid abnormalities
  • Anticoagulation therapy
  • Cancer history including breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Many Locations, Bulgaria

Location

Unknown Facility

Many Locations, Croatia

Location

Unknown Facility

Many Locations, India

Location

Unknown Facility

Many Locations, Jordan

Location

Unknown Facility

Many Locations, Kuwait

Location

Unknown Facility

Many Locations, Pakistan

Location

Unknown Facility

Many Locations, Romania

Location

Unknown Facility

Many Locations, Russia

Location

Unknown Facility

Many Locations, Saudi Arabia

Location

Unknown Facility

Many Locations, Serbia

Location

Unknown Facility

Many Locations, Sri Lanka

Location

Unknown Facility

Many Locations, Turkey (Türkiye)

Location

Unknown Facility

Many Locations, United Arab Emirates

Location

Biospecimen

Retention: NONE RETAINED

Serum

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

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

March 23, 2009

First Posted

March 24, 2009

Study Start

August 1, 2004

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

SR(1)RO(1)IN(1)TU(1)AE(1)JO(1)SE(1)BU(1)CR(1)KU(1)PA(1)SA(1)RU(1)