Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.

Detailed Description
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Acronyms in the Adverse Event Section: IUCD Intrauterine Contraceptive Device MedDRA Medical Dictionary for Regulatory Activities This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer HealthCare AG, Germany.

Official Title
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A Multicenter, Randomized, Open Label, Parallel Group, Active Control Study to Evaluate the Efficacy and Safety of LNG IUS (Mirena®) as Compared to Medroxyprogesterone Acetate During 6 Cycles of Treatment in Patients With Idiopathic Menorrhagia

Conditions
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Menorrhagia

Intervention / Treatment
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* Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
* Drug: Medroxyprogesterone acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who have >/= 80 mL blood loss during their menstrual cycles and desire contraception Exclusion Criteria: Post menopausal menstrual cycle < 21 days or > 35 days Pregnancy

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours<br>Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. | Drug: Levonorgestrel IUS (Mirena, BAY86-5028)<br>* Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.<br>|
| Active Comparator: Medroxyprogesterone acetate (MPA)<br>Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles. | Drug: Medroxyprogesterone acetate<br>* Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) | The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase. | Baseline and up to 6 months | 
| Percentage of Patients With Successful Treatment | End-of-study MBL < 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success. | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline MBL to End of Study MBL (Cycle 6) | The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100. | Baseline and up to 6 months | 
| Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3) | The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase. | Baseline and up to 3 months | 
| Percent Change From Baseline MBL to Mid-study MBL (Cycle 3) | The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100. | Baseline and up to 3 months | 
| Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group |  | Baseline and up to 6 months | 
| Total Number of Bleeding Days | In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts. | Baseline and up to 6 months | 
| Total Number of Spotting and Bleeding Days | In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts. | Baseline and up to 6 months | 
| Total Number of Spotting Days | In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts. | Baseline and up to 6 months | 
| Total Number of Bleeding Episodes | A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts. | Baseline and up to 6 months | 
| Percent Change in Hemoglobin |  | Baseline and up to 6 months | 
| Percent Change in Hematocrit |  | Baseline and up to 6 months | 
| Percent Change in Serum Ferritin |  | Baseline and up to 6 months | 
| Percentage of Patients With Improvement in the Investigator Global Assessment Scale | Improved is classified as 'very much improved', 'much improved', or 'improved' and not improved is classified as 'no change', 'worse', 'much worse', or 'very much worse' | Up to 6 months | 
| Percentage of Patients With Improvement in the Patients Overall Assessment Scale | Improved is classified as 'very much improved', 'much improved', or 'improved' and not improved is classified as 'no change', 'worse', 'much worse', or 'very much worse'. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Menorrhagia