Resumen

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

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

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.

Ubicaciones

Buenos Aires, Argentina, Argentina

Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalBayer

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