NCT00393198

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

Multicenter Study to Investigate the Bleeding Profile and the Insertion Easiness in Women Inserted With a Second Consecutive MIRENA for Contraception or Menorrhagia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 23 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Contraception
• Menorrhagia

Interventions

Type	Name	Description
DRUG	Levonorgestrel (Mirena, BAY86-5028)	Removal of first MIRENA and insertion of the second MIRENA at entry visit. Removal of MIRENA (in vitro release rate 20 microgram/24h) at year 5 visit.
DRUG	Cytotec	Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit
DRUG	Placebo	Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.

Timeline

• Start date: 2006-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2006-10-27
• Last updated: 2014-11-03

Locations

17 sites across 4 countries: Finland, France, Ireland, Sweden