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

NCT00393198 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2014-11-03

No results posted yet for this study

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.

Conditions

  • Contraception
  • Menorrhagia

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Finland
  • France
  • Ireland
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00393198 on ClinicalTrials.gov