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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
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.
Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit
Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.
Unnamed facility
Helsinki, Finland
Unnamed facility
Hyvinkää, Finland
Unnamed facility
Jyväskylä, Finland
Primary efficacy variable will be bleeding profile
Time frame: Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5
Secondary efficacy variables will be insertion assessment, continuation rate, pregnancy rate and menstrual comfort and user satisfaction
Time frame: Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Kuopio, Finland
Unnamed facility
Tampere, Finland
Unnamed facility
Turku, Finland
Unnamed facility
Brignoles, France
Unnamed facility
Compiègne, France
Unnamed facility
Nancy, France
Unnamed facility
Quetigny, France
...and 7 more locations