Trial Condition(s):

Contraception, Menorrhagia

Bleeding pattern and user satisfaction during second consecutive MIRENA® in contraception and treatment of menorrhagia

Bayer Identifier:

91473

ClinicalTrials.gov Identifier:

NCT00393198

EudraCT Number:

2006-000394-30

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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.
Exclusion Criteria
- 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.

Trial Summary

Enrollment Goal
204
Trial Dates
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Phase
4
Could I receive a placebo?
Yes
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Länsi-Suomen Erikoislääkäripalvelut Oy

Turku, Finland, 20100

Status
Completed
 
Locations

Lääkäriasema Cantti Oy

Kuopio, Finland, 70110

Status
Completed
 
Locations

Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, S-171 76

Status
Completed
 
Locations

Södersjukhuset

Stockholm, Sweden, 118 83

Status
Completed
 
Locations

Prima Liv

Stockholm, Sweden, 182 88

Status
Completed
 
Locations

Number 47 Medical Practice

Drogheda, Ireland

Status
Completed
 
Locations

The Practrice

Mallow, Ireland

Status
Completed
 
Locations

Cabinet gynecologie

ROANNE, France, 42300

Status
Completed
 
Locations

Maternité Régionale - Nancy

Nancy Cedex, France, 54042

Status
Completed
 
Locations

Dr. Jocelyne Nataf-Maurin

Brignoles, France, 83170

Status
Completed
 
Locations

Terveystalo Jyväskylä

Jyväskylä, Finland, 40100

Status
Completed
 
Locations

Mehiläinen Hyvinkää

Hyvinkää, Finland, 05800

Status
Completed
 
Locations

Lääkäriasema Femeda

Helsinki, Finland, 00100

Status
Completed
 
Locations

Suomen Terveystalo Tampere

Tampere, Finland, 33100

Status
Completed
 
Locations

Polyclinique Saint Come

Compiegne Cedex, France, 60204

Status
Completed
 
Locations

Clinique de Courlancy Reims

Reims, France, 51100

Status
Completed
 
Locations

Cabinet medical

Quetigny, France, 21800

Status
Completed
 

Trial Design