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

Phase 3

Completed

• Conditions: Menorrhagia
• Interventions: Drug: Levonorgestrel IUS (Mirena, BAY86-5028); Drug: Medroxyprogesterone acetate

• Registration Number: NCT00360490
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-02
• Study First Submitted QC: 2006-08-02
• Study First Posted: 2006-08-04
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-10-13
• Results First Submitted QC: 2009-10-13
• Results First Posted: 2009-11-19
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours	Levonorgestrel IUS (Mirena, BAY86-5028)	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetate (MPA)	Medroxyprogesterone acetate	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Primary Outcome Measures

Name	Time	Method
The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)	Baseline and up to 6 months	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.
Percentage of Patients With Successful Treatment	At 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline MBL to End of Study MBL (Cycle 6)	Baseline and up to 6 months	The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.
Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)	Baseline and up to 3 months	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.
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group	Baseline and up to 6 months
Total Number of Bleeding Episodes	Baseline and up to 6 months	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.
Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)	Baseline and up to 3 months	The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.
Total Number of Bleeding Days	Baseline and up to 6 months	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.
Percent Change in Hemoglobin	Baseline and up to 6 months
Total Number of Spotting and Bleeding Days	Baseline and up to 6 months	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.
Total Number of Spotting Days	Baseline and up to 6 months	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.
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	Up to 6 months	"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'
Percentage of Patients With Improvement in the Patients Overall Assessment Scale	Up to 6 months	"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'.