check_circleStudy Completed

Contraception, Menorrhagia

Bayer Identifier:

91473

ClinicalTrials.gov Identifier:

NCT00393198

EudraCT Number:

2006-000394-30

EU CT Number:

Not Available
Bleeding pattern and user satisfaction during second consecutive MIRENA® in contraception and treatment of menorrhagia

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.

Key Participants Requirements

Sex

Female

Age

23 - 45 Years
  • - 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.
  • - 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
October 2006 - October 2012
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Länsi-Suomen Erikoislääkäripalvelut OyTurku, 20100, Finland
Completed
Lääkäriasema Cantti OyKuopio, 70110, Finland
Completed
Karolinska Universitetssjukhuset i SolnaStockholm, S-171 76, Sweden
Completed
SödersjukhusetStockholm, 118 83, Sweden
Completed
Prima LivStockholm, 182 88, Sweden
Completed
Number 47 Medical PracticeDrogheda, Ireland
Completed
The PractriceMallow, Ireland
Completed
Cabinet gynecologieROANNE, 42300, France
Completed
Maternité Régionale - NancyNancy Cedex, 54042, France
Completed
Dr. Jocelyne Nataf-MaurinBrignoles, 83170, France
Completed
Terveystalo JyväskyläJyväskylä, 40100, Finland
Completed
Mehiläinen HyvinkääHyvinkää, 05800, Finland
Completed
Lääkäriasema FemedaHelsinki, 00100, Finland
Completed
Suomen Terveystalo TampereTampere, 33100, Finland
Completed
Polyclinique Saint ComeCompiegne Cedex, 60204, France
Completed
Clinique de Courlancy ReimsReims, 51100, France
Completed
Cabinet medicalQuetigny, 21800, France

Primary Outcome

  • Primary efficacy variable will be bleeding profile
    date_rangeTime Frame:
    Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction
    date_rangeTime Frame:
    Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Multicenter study to investigate the bleeding profile and the insertion easiness in women inserted with a second consecutive MIRENA for contraception or menorrhagia
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.