NCT00393198

Brief Summary

The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_4

Geographic Reach
4 countries

17 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

October 1, 2006

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2006

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

6 years

First QC Date

October 26, 2006

Last Update Submit

October 31, 2014

Conditions

ContraceptionMenorrhagia

Keywords

Intrauterine SystemContraceptionMenorrhagia

Outcome Measures

Primary Outcomes (1)

  • Primary efficacy variable will be bleeding profile

    Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5

Secondary Outcomes (1)

  • Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction

    Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: Levonorgestrel (Mirena, BAY86-5028)

Arm 2

PLACEBO COMPARATOR
Drug: Cytotec

Arm 3

ACTIVE COMPARATOR
Drug: Placebo

Interventions

Levonorgestrel (Mirena, BAY86-5028)DRUG

Removal of first MIRENA and insertion of the second MIRENA at entry visit. Removal of MIRENA (in vitro release rate 20 microgram/24h) at year 5 visit.

Arm 1
CytotecDRUG

Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit

Arm 2
PlaceboDRUG

Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.

Arm 3

Eligibility Criteria

Age23 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Woman currently using MIRENA for contraception or menorrhagia with duration use between 4 years 3 months and 4 years 9 months and willingness to continue with the method.
  • Normal size uterus at insertion, corresponding to sound measure of 6-10 cm.
  • Clinically normal cervical smear result within 12 preceding months or at screening.
  • Clinically normal breast examination findings. For patients \>/= 40 years at screening, a clinically normal mammography result within 12 preceding months or at screening is required.

You may not qualify if:

  • Menopausal symptoms impairing patient's quality of life or current estrogen therapy for menopausal symptoms.
  • Known or suspected pregnancy.
  • Any distortion of the uterine cavity, including congenital or acquired uterine anomalies and fibroids distorting the uterine cavity.
  • Current or recurrent pelvic inflammatory disease.
  • Abnormal uterine bleeding of unknown origin.
  • Acute cervicitis or vaginitis not responding to treatment.
  • History of, diagnosed or suspected genital or other malignancy (excluding treated squamous cell carcinoma of the skin), and untreated cervical dysplasia.
  • Any active acute liver disease or liver tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Helsinki, 00100, Finland

Location

Unknown Facility

Hyvinkää, 05800, Finland

Location

Unknown Facility

Jyväskylä, 40100, Finland

Location

Unknown Facility

Kuopio, 70110, Finland

Location

Unknown Facility

Tampere, 33100, Finland

Location

Unknown Facility

Turku, 20100, Finland

Location

Unknown Facility

Brignoles, 83170, France

Location

Unknown Facility

Compiègne, 60204, France

Location

Unknown Facility

Nancy, 54042, France

Location

Unknown Facility

Quetigny, 21800, France

Location

Unknown Facility

Reims, 51100, France

Location

Unknown Facility

Roanne, 42300, France

Location

Unknown Facility

Mallow, Cork, Ireland

Location

Unknown Facility

Drogheda, Ireland

Location

Unknown Facility

Stockholm, 118 83, Sweden

Location

Unknown Facility

Stockholm, 182 88, Sweden

Location

Unknown Facility

Stockholm, S-171 76, Sweden

Location

Related Publications (4)

  • Heikinheimo O, Inki P, Kunz M, Parmhed S, Anttila AM, Olsson SE, Hurskainen R, Gemzell-Danielsson K. Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system. Contraception. 2010 Jun;81(6):481-6. doi: 10.1016/j.contraception.2010.01.020. Epub 2010 Mar 1.

    PMID: 20472114RESULT

  • Gemzell-Danielsson K, Inki P, Boubli L, O'Flynn M, Kunz M, Heikinheimo O. Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)--a multicentre prospective study. Hum Reprod. 2010 Feb;25(2):354-9. doi: 10.1093/humrep/dep426. Epub 2009 Dec 1.

    PMID: 19955104RESULT

  • Heikinheimo O, Inki P, Kunz M, Gemzell-Danielsson K. Predictors of bleeding and user satisfaction during consecutive use of the levonorgestrel-releasing intrauterine system. Hum Reprod. 2010 Jun;25(6):1423-7. doi: 10.1093/humrep/deq079. Epub 2010 Apr 8.

    PMID: 20378611RESULT

  • Heikinheimo O, Inki P, Schmelter T, Gemzell-Danielsson K. Bleeding pattern and user satisfaction in second consecutive levonorgestrel-releasing intrauterine system users: results of a prospective 5-year study. Hum Reprod. 2014 Jun;29(6):1182-8. doi: 10.1093/humrep/deu063. Epub 2014 Mar 28.

    PMID: 24682613DERIVED

MeSH Terms

Conditions

Menorrhagia

Interventions

LevonorgestrelMisoprostol

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 27, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations

SE(3)FI(6)IE(2)FR(6)