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)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menorrhagia

Interventions

Type	Name	Description
DRUG	Levonorgestrel IUS (Mirena, BAY86-5028)	Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
DRUG	Medroxyprogesterone acetate	Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-08-04
• Last updated: 2013-12-09
• Results posted: 2009-11-19

Locations

54 sites across 5 countries: United States, Argentina, Brazil, Canada, Mexico