Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).

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.

Detailed description: 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. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women with intact uterus, regular menstrual cycles and no previous or current

climacteric symptoms.

Exclusion Criteria:

- Pregnancy or lactation.

- Previous pelvic infections.

- Abnormal bleeding.

- Abnormal uterine cavity.

- Uterine polyps.

- Genital cancer.

- Liver diseases.

- Alcoholism or drug abuse.

Starting date: May 2000
Last updated: June 14, 2007