Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Levonorgestrel; Misoprostol

Criteria

Inclusion Criteria:

• Woman currently using MIRENA for contraception or menorrhagia with duration use between 4 years 3 months and 4 years 9 months and willingness to continue with the method.

• Normal size uterus at insertion, corresponding to sound measure of 6-10 cm.

• Clinically normal cervical smear result within 12 preceding months or at screening.

• Clinically normal breast examination findings. For patients >/= 40 years at screening, a clinically normal mammography result within 12 preceding months or at screening is required.

Exclusion Criteria:

• Menopausal symptoms impairing patient's quality of life or current estrogen therapy for menopausal symptoms.

• Known or suspected pregnancy.

• Any distortion of the uterine cavity, including congenital or acquired uterine anomalies and fibroids distorting the uterine cavity.

• Current or recurrent pelvic inflammatory disease.

• Abnormal uterine bleeding of unknown origin.

• Acute cervicitis or vaginitis not responding to treatment.

• History of, diagnosed or suspected genital or other malignancy (excluding treated squamous cell carcinoma of the skin), and untreated cervical dysplasia.

• Any active acute liver disease or liver tumor.