Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Menopause
Intervention: Mirena® (Device)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Bayer
Official(s) and/or principal investigator(s):
Bayer Schering Pharma AG, Germany, Medical Affairs, Study Director, Affiliation: T. +49 30 468 11800
The study has been designed to look at the transfer from using LNG IUS for contraception
only, in reproductive age to using it for endometrial protection in menopausal age. The main
area of interest in the study is the pattern of any vaginal bleeding that occurs.
Official title: A 36-Month Non-Comparative Study on Bleeding Profiles With Levonorgestrel Intrauterine System in Transition From Reproductive Age Contraception to Menopause Age Endometrial Protection During Estrogen Replacement Therapy.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Assessment of vaginal bleeding; numbers of bleeding and spotting days.
Secondary outcome: Quality of life, progestogenic and climacteric symptoms, continuation rates.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Minimum age: 46 Years.
Maximum age: 51 Years.
- Women with intact uterus, regular menstrual cycles and no previous or current
- Pregnancy or lactation.
- Previous pelvic infections.
- Abnormal bleeding.
- Abnormal uterine cavity.
- Uterine polyps.
- Genital cancer.
- Liver diseases.
- Alcoholism or drug abuse.
Locations and Contacts
Starting date: May 2000
Last updated: June 14, 2007