Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia

Study Overview
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Brief Summary
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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.

Detailed Description
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This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
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Multicenter Study to Investigate the Bleeding Profile and the Insertion Easiness in Women Inserted With a Second Consecutive MIRENA for Contraception or Menorrhagia

Conditions
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Contraception, Menorrhagia

Intervention / Treatment
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* Drug: Levonorgestrel (Mirena, BAY86-5028)
* Drug: Cytotec
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levonorgestrel (Mirena, BAY86-5028)<br>* Removal of first MIRENA and insertion of the second MIRENA at entry visit. Removal of MIRENA (in vitro release rate 20 microgram/24h) at year 5 visit.<br>|
| Placebo Comparator: Arm 2<br> | Drug: Cytotec<br>* Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit<br>|
| Active Comparator: Arm 3<br> | Drug: Placebo<br>* Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy variable will be bleeding profile |  | Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction |  | Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine System, Contraception, Menorrhagia