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

Phase 4

Completed

• Conditions: Contraception; Menorrhagia
• Interventions: Drug: Levonorgestrel (Mirena, BAY86-5028); Drug: Cytotec; Drug: Placebo

• Registration Number: NCT00393198
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-26
• Study First Submitted QC: 2006-10-26
• Study First Posted: 2006-10-27
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-31
• Last Update Posted: 2014-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Levonorgestrel (Mirena, BAY86-5028)	-
Arm 2	Cytotec	-
Arm 3	Placebo	-

Primary Outcome Measures

Name	Time	Method
Primary efficacy variable will be bleeding profile	Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction	Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5