NCT00696202

Brief Summary

In this trial the efficacy and safety of Mirena was investigated during the first year of use

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2003

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

September 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

First QC Date

June 10, 2008

Last Update Submit

December 30, 2014

Conditions

Medicated Intrauterine DevicesContraception

Keywords

MirenaLevonorgestrelIntrauterine deviceEfficacyTolerabilityFirst year of use

Outcome Measures

Primary Outcomes (1)

  • Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena

    within 12 months after randomization

Secondary Outcomes (1)

  • General safety assessment

    within 12 months after randomization

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Mirena (BAY86-5028)

Interventions

Mirena (BAY86-5028)DRUG

Intrauterine levonorgestrel containing device (market product)

Arm 1

Eligibility Criteria

Age25 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Amiens, 80054, France

Location

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

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
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 12, 2008

Study Start

September 1, 2003

Study Completion

March 1, 2005

Last Updated

December 31, 2014

Record last verified: 2014-12

Locations

FR(1)