NCT00498784

Brief Summary

The purpose of this study is to evaluate the changes in the quality of life, as well as in the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine system, over the first 12 months of use. Patients switching from oral contraception to an intrauterine contraceptive device (here: MIRENA) will be observed in the first year post MIRENA insertion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2005

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

November 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

July 9, 2007

Last Update Submit

January 21, 2013

Conditions

Contraception

Keywords

Intra-uterine contraceptionIntrauterine Devices

Outcome Measures

Primary Outcomes (1)

  • Health-related QoL score

    1 year

Secondary Outcomes (1)

  • Sexuality Index, treatment satisfaction, usual safety outcomes

    1 year

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Mirena

Interventions

MirenaDRUG

Mirena 52mg during 1 year

Arm 1

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy woman willing to, or having to switch from her OC to another contraceptive method

You may not qualify if:

  • \- Any contraindication to Mirena insertion/use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bordeaux, Gironde, 33076, 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

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

November 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

FR(1)