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

NCT00360490 | Completed Phase 3 Results

• 2 other identifiers: 91518309849
• Study Type: interventional
• Target: 165
• Locations: 5 countries
• Sites: 54

Brief Summary

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

Conditions

Menorrhagia

Keywords

Idiopathic Menorrhagia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Percent Change From Baseline MBL to End of Study MBL (Cycle 6)

  Baseline and up to 6 months

• Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)

  Baseline and up to 3 months

• Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)

  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

  Baseline and up to 6 months

Study Arms (2)

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)

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

Interventions

Levonorgestrel IUS (Mirena, BAY86-5028) DRUG

Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.

Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours

Medroxyprogesterone acetate DRUG

Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Medroxyprogesterone acetate (MPA)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who have \>/= 80 mL blood loss during their menstrual cycles and desire contraception

You may not qualify if:

• Post menopausal menstrual cycle \< 21 days or \> 35 days
• Pregnancy

Sponsors & Collaborators

• Bayer: lead

Study Sites (54)

Unknown Facility

Tucson, Arizona, 85712, United States

Location

Unknown Facility

Beverly Hills, California, 90211, United States

Location

Unknown Facility

Carmichael, California, 95608, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

San Diego, California, 92108, United States

Location

Unknown Facility

Santa Monica, California, 90403, United States

Location

Unknown Facility

Torrance, California, 90509, United States

Location

Unknown Facility

Littleton, Colorado, 80122, United States

Location

Unknown Facility

Boynton Beach, Florida, 33437, United States

Location

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

West Palm Beach, Florida, 33409, United States

Location

Unknown Facility

Boise, Idaho, 83702, United States

Location

Unknown Facility

Chicago, Illinois, 60612, United States

Location

Unknown Facility

Newburgh, Indiana, 47630, United States

Location

Unknown Facility

South Bend, Indiana, 46601, United States

Location

Unknown Facility

Amite, Louisiana, 70422, United States

Location

Unknown Facility

Marrero, Louisiana, 70072, United States

Location

Unknown Facility

Boston, Massachusetts, 02118, United States

Location

Unknown Facility

Saginaw, Michigan, 48602, United States

Location

Unknown Facility

Chesterfield, Missouri, 63017, United States

Location

Unknown Facility

Lincoln, Nebraska, 68510, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

LasVegas, Nevada, 89106, United States

Location

Unknown Facility

Moorestown, New Jersey, 08057, United States

Location

Unknown Facility

New Brunswick, New Jersey, 08901, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Medford, Oregon, 97504, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19114, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15206, United States

Location

Unknown Facility

Columbia, South Carolina, 29201, United States

Location

Unknown Facility

Clarksville, Tennessee, 37043, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Burlington, Vermont, 05401, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

Unknown Facility

Seattle, Washington, 98105, United States

Location

Unknown Facility

Buenos Aires, Argentina, C1181ACH, Argentina

Location

Unknown Facility

Buenos Aires, Buenos Aires, 1425, Argentina

Location

Unknown Facility

Curitiba, Paraná, 80030-220, Brazil

Location

Unknown Facility

Campinas, São Paulo, 13083-970, Brazil

Location

Unknown Facility

Bathurst, New Brunswick, E2A 4X7, Canada

Location

Unknown Facility

Ottawa, Ontario, K1H7W9, Canada

Location

Unknown Facility

Toronto, Ontario, M4S 1Y2, Canada

Location

Unknown Facility

Mirabel, Quebec, J7J 1L2, Canada

Location

Unknown Facility

Montreal, Quebec, H1T 1P6, Canada

Location

Unknown Facility

Montreal, Quebec, H2X 1N8, Canada

Location

Unknown Facility

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Unknown Facility

Québec, Quebec, G1S 2L6, Canada

Location

Unknown Facility

Shawinigan, Quebec, G9N 2H6, Canada

Location

Unknown Facility

Regina, Saskatchewan, S4S 0A2, Canada

Location

Unknown Facility

Mexico City, Mexico City, 11000, Mexico

Location

Unknown Facility

Monterrey, Nuevo León, 64460, Mexico

Location

Unknown Facility

México, State of Mexico, 16720, Mexico

Location

Related Publications (3)

• 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.

  PMID: 21475963 RESULT

• 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.

  PMID: 22959906 RESULT

• 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.

  PMID: 20733445 RESULT

MeSH Terms

Conditions

Menorrhagia

Interventions

Levonorgestrel; Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2006
• First Posted: August 4, 2006
• Study Start: July 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 9, 2013
• Results First Posted: November 19, 2009

Record last verified: 2013-11

Locations

CA (10); ME (3); AR (2); BR (2); US (37)