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

November 14, 2013 updated by: Bayer

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
165

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
      • Buenos Aires, Argentina, C1181ACH
  • Brazil
    • Parana
      • Curitiba, Parana, Brazil, 80030-220
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13083-970
  • Canada
      • Quebec, Canada, G1S 2L6
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E2A 4X7
    • Ontario
      • Ottawa, Ontario, Canada, K1H7W9
      • Toronto, Ontario, Canada, M4S 1Y2
    • Quebec
      • Mirabel, Quebec, Canada, J7J 1L2
      • Montreal, Quebec, Canada, H2X 1N8
      • Montreal, Quebec, Canada, H1T 1P6
      • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Shawinigan, Quebec, Canada, G9N 2H6
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4S 0A2
  • Mexico
      • Mexico Df, Mexico, 11000
    • México
      • Mexico, México, Mexico, 16720
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
    • California
      • Beverly Hills, California, United States, 90211
      • Carmichael, California, United States, 95608
      • San Diego, California, United States, 92103
      • San Diego, California, United States, 92108
      • Santa Monica, California, United States, 90403
      • Torrance, California, United States, 90509
    • Colorado
      • Littleton, Colorado, United States, 80122
    • Florida
      • Boynton Beach, Florida, United States, 33437
      • Jacksonville, Florida, United States, 32216
      • West Palm Beach, Florida, United States, 33409
    • Idaho
      • Boise, Idaho, United States, 83702
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Indiana
      • Newburgh, Indiana, United States, 47630
      • South Bend, Indiana, United States, 46601
    • Louisiana
      • Amite, Louisiana, United States, 70422
      • Marrero, Louisiana, United States, 70072
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
    • Michigan
      • Saginaw, Michigan, United States, 48602
    • Missouri
      • Chesterfield, Missouri, United States, 63017
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
    • Nevada
      • Las Vegas, Nevada, United States
      • LasVegas, Nevada, United States, 89106
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
      • New Brunswick, New Jersey, United States, 08901
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
    • Oregon
      • Medford, Oregon, United States, 97504
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
      • Pittsburgh, Pennsylvania, United States, 15206
    • South Carolina
      • Columbia, South Carolina, United States, 29201
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
    • Texas
      • Houston, Texas, United States
      • Houston, Texas, United States, 77030
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Norfolk, Virginia, United States, 23507
    • Washington
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Active Comparator: Medroxyprogesterone acetate (MPA)
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Drug: Medroxyprogesterone acetate
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: 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.
Baseline and up to 6 months
Percentage of Patients With Successful Treatment
Time Frame: 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.
At 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline MBL to End of Study MBL (Cycle 6)
Time Frame: Baseline and up to 6 months
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)
Time Frame: 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.
Baseline and up to 3 months
Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
Time Frame: Baseline and up to 3 months
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
Time Frame: Baseline and up to 6 months
Baseline and up to 6 months
Total Number of Bleeding Days
Time Frame: 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.
Baseline and up to 6 months
Total Number of Spotting and Bleeding Days
Time Frame: 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.
Baseline and up to 6 months
Total Number of Spotting Days
Time Frame: 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.
Baseline and up to 6 months
Total Number of Bleeding Episodes
Time Frame: 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.
Baseline and up to 6 months
Percent Change in Hemoglobin
Time Frame: Baseline and up to 6 months
Baseline and up to 6 months
Percent Change in Hematocrit
Time Frame: Baseline and up to 6 months
Baseline and up to 6 months
Percent Change in Serum Ferritin
Time Frame: Baseline and up to 6 months
Baseline and up to 6 months
Percentage of Patients With Improvement in the Investigator Global Assessment Scale
Time Frame: 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'
Up to 6 months
Percentage of Patients With Improvement in the Patients Overall Assessment Scale
Time Frame: 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'.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 91518
  • 309849 (Other Identifier: Bayer)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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