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

EU CT Number:

Not Available

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
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Länsi-Suomen Erikoislääkäripalvelut Oy

Turku, Finland, 20100

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Lääkäriasema Cantti Oy

Kuopio, Finland, 70110

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Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, S-171 76

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Södersjukhuset

Stockholm, Sweden, 118 83

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Prima Liv

Stockholm, Sweden, 182 88

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Number 47 Medical Practice

Drogheda, Ireland

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The Practrice

Mallow, Ireland

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Cabinet gynecologie

ROANNE, France, 42300

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Maternité Régionale - Nancy

Nancy Cedex, France, 54042

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Dr. Jocelyne Nataf-Maurin

Brignoles, France, 83170

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Terveystalo Jyväskylä

Jyväskylä, Finland, 40100

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Mehiläinen Hyvinkää

Hyvinkää, Finland, 05800

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Lääkäriasema Femeda

Helsinki, Finland, 00100

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Suomen Terveystalo Tampere

Tampere, Finland, 33100

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Polyclinique Saint Come

Compiegne Cedex, France, 60204

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Clinique de Courlancy Reims

Reims, France, 51100

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Cabinet medical

Quetigny, France, 21800

Trial Design