Clinical trial NCT00360490: Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menorrhagia
Keywords: Idiopathic Menorrhagia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-08-04
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)
timeFrame: Baseline and up to 6 months
measure: Percentage of Patients With Successful Treatment
timeFrame: At 6 months
Secondary outcomes:
measure: Percent Change From Baseline MBL to End of Study MBL (Cycle 6)
timeFrame: Baseline and up to 6 months
measure: Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)
timeFrame: Baseline and up to 3 months
measure: Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
timeFrame: Baseline and up to 3 months
measure: Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
timeFrame: Baseline and up to 6 months
measure: Total Number of Bleeding Days
timeFrame: Baseline and up to 6 months
measure: Total Number of Spotting and Bleeding Days
timeFrame: Baseline and up to 6 months
measure: Total Number of Spotting Days
timeFrame: Baseline and up to 6 months
measure: Total Number of Bleeding Episodes
timeFrame: Baseline and up to 6 months
measure: Percent Change in Hemoglobin
timeFrame: Baseline and up to 6 months
measure: Percent Change in Hematocrit
timeFrame: Baseline and up to 6 months
measure: Percent Change in Serum Ferritin
timeFrame: Baseline and up to 6 months
measure: Percentage of Patients With Improvement in the Investigator Global Assessment Scale
timeFrame: Up to 6 months
measure: Percentage of Patients With Improvement in the Patients Overall Assessment Scale
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Carmichael
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Torrance
country: United States
state: California
city: Littleton
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Newburgh
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Amite
country: United States
state: Louisiana
city: Marrero
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Saginaw
country: United States
state: Michigan
city: Chesterfield
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: LasVegas
country: United States
state: Nevada
city: Moorestown
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Clarksville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Curitiba
country: Brazil
state: Parana
city: Campinas
country: Brazil
state: Sao Paulo
city: Bathurst
country: Canada
state: New Brunswick
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Mirabel
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
city: Shawinigan
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
city: Mexico
country: Mexico
state: México
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Mexico Df
country: Mexico
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Endrikat J, Vilos G, Muysers C, Fortier M, Solomayer E, Lukkari-Lax E. The levonorgestrel-releasing intrauterine system provides a reliable, long-term treatment option for women with idiopathic menorrhagia. Arch Gynecol Obstet. 2012 Jan;285(1):117-21. doi: 10.1007/s00404-011-1902-1. Epub 2011 Apr 8.
citation: Kaunitz AM, Bissonnette F, Monteiro I, Lukkari-Lax E, DeSanctis Y, Jensen J. Levonorgestrel-releasing intrauterine system for heavy menstrual bleeding improves hemoglobin and ferritin levels. Contraception. 2012 Nov;86(5):452-7. doi: 10.1016/j.contraception.2012.07.018. Epub 2012 Sep 7.
citation: Kaunitz AM, Bissonnette F, Monteiro I, Lukkari-Lax E, Muysers C, Jensen JT. Levonorgestrel-releasing intrauterine system or medroxyprogesterone for heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):625-632. doi: 10.1097/AOG.0b013e3181ec622b.