At a glance
ClinicalIndex Comparison Record- ✓Women with intact uterus
- ✓Regular menstrual cycles
- ✓No previous or current climacteric symptoms
- ✕Pregnancy or lactation
- ✕Previous pelvic infections
- ✕Abnormal bleeding
- ✕Abnormal uterine cavity
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 60-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.
In Brief
A Phase 3 clinical trial evaluating LNG IUS for Menopause. Completed, enrolled 394 participants across 12 sites in 4 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.