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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00360490

Purpose

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

Condition	Intervention	Phase
Menorrhagia	Drug: Levonorgestrel IUS (Mirena, BAY86-5028) Drug: Medroxyprogesterone acetate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Menstruation

Drug Information available for: Medroxyprogesterone 17-acetate Medroxyprogesterone Levonorgestrel

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Percentage of Patients With Successful Treatment [ Time Frame: At 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent Change From Baseline MBL to End of Study MBL (Cycle 6) [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3) [ Time Frame: Baseline and up to 3 months ] [ Designated as safety issue: No ]
Percent Change From Baseline MBL to Mid-study MBL (Cycle 3) [ Time Frame: Baseline and up to 3 months ] [ Designated as safety issue: No ]
Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
Total Number of Bleeding Days [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
Total Number of Spotting and Bleeding Days [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
Total Number of Spotting Days [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
Total Number of Bleeding Episodes [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
Percent Change in Hemoglobin [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
Percent Change in Hematocrit [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
Percent Change in Serum Ferritin [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
Percentage of Patients With Improvement in the Investigator Global Assessment Scale [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
Percentage of Patients With Improvement in the Patients Overall Assessment Scale [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Enrollment:	165
Study Start Date:	July 2006
Study Completion Date:	August 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours: Experimental 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.
Medroxyprogesterone acetate (MPA): Active Comparator 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.

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 Schering Pharma AG, Germany.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360490

Show 49 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

This study is the same study protocol as NCT00360620, with different locations. This link exits the ClinicalTrials.gov site

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer HealthCare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	91518, 309849
Study First Received:	August 2, 2006
Results First Received:	October 13, 2009
Last Updated:	January 12, 2010
ClinicalTrials.gov Identifier:	NCT00360490 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Idiopathic Menorrhagia

Additional relevant MeSH terms:

Menorrhagia
Medroxyprogesterone 17-Acetate
Antineoplastic Agents, Hormonal
Uterine Hemorrhage
Antineoplastic Agents
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Uterine Diseases

Reproductive Control Agents
Contraceptive Agents, Male
Pharmacologic Actions
Genital Diseases, Female
Pathologic Processes
Menstruation Disturbances
Therapeutic Uses
Levonorgestrel
Contraceptives, Oral, Synthetic
Medroxyprogesterone

ClinicalTrials.gov processed this record on February 08, 2010