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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

Levonorgestrel-releasing intrauterine system - Mirena, 2. Medroxyprogesterone acetate tablets 10 mg, oral administration for 10 consecutive days beginning on the 16th day of the menstrual cycle).

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.

Intervention(s) in this Clinical Trial

• Drug: Levonorgestrel-releasing intrauterine system
  • Levonorgestrel-releasing intrauterine system - Mirena
• Drug: Medroxyprogesterone acetate
  • Medroxyprogesterone acetate tablets 10 mg, oral administration for 10 consecutive days beginning on the 16th day of the menstrual cycle

Arms, Groups and Cohorts in this Clinical Trial

• Other: Arm 1
• Active Comparator: Arm 2

Primary Measures

• To determine the absolute change in mentrual blood loss ( MBL)from baseline to end of study (Cycle 6) to determine the proportion of patients with successful treatment
  • Time Frame: 6 cycles
    Safety Issue?: No

Secondary Measures

• To determine the absolute change and percent change from Baseline MBL to Mid-study MBL
  • Time Frame: From baseline to cycle 3
    Safety Issue?: No
• To determine the percent change from Baseline MBL to End of study MBL
  • Time Frame: From baseline to cycle 6
    Safety Issue?: No
• To determine the continuation rate
  • Time Frame: Entire study
    Safety Issue?: No
• To determine the total number of days of bleeding, spotting, bleeding and spotting, and total number of bleeding episodes
  • Time Frame: Entire study
    Safety Issue?: No
• To evaluate the percent change in hemoglobin, hematocrit and serum ferritin
  • Time Frame: From baseline to cycle 3 and from cycle 3 to cycle 6 and from baseline to cycle 6
    Safety Issue?: No
• To determine the proportion of patients with improvement in the Investigator and Patient Global Assessment Scale at Cycle 3 and Cycle 6
  • Time Frame: At cycle 3 and cycle 6
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00360490

Study ID Number: 91518

ClinicalTrials.gov Identifier: NCT00360490

Health Authority: United States: Food and Drug Administration

This study is the same study protocol as NCT00360620, with different locations.

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