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

Bayer

Status and phase: Completed; Phase 3

Conditions: Menorrhagia

Treatments: Drug: Medroxyprogesterone acetate; Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00360490

91518

309849 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 165 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Medroxyprogesterone acetate (MPA)

Active Comparator group

Description:

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

Treatment:

Drug: Medroxyprogesterone acetate