Trial intelligence / Profile preview

Dose Finding Study of Ultra Low Dose Levonorgestrel IUS vs Mirena

NCT00185380Phase 2

Key facts

Status: Completed
Start: Apr 2005
Primary completion: Dec 2008
Countries: 5
Sponsor: Bayer
Modality: Small Molecules

Drugs: levonorgestrel intrauterine system
Conditions: contraception

Overview

Phase 2, randomised, single-blind trial of levonorgestrel intrauterine system in contraception (3 arms), sponsored by Bayer. Primary endpoint: Pearl Index at 3 years. Started Apr 2005; status: completed.

Design

3 arms

Study design: RandomizedSingle-blind

LCS12
Levonorgestrel IUS releasing 12 µg/24h
LCS16
Levonorgestrel IUS releasing 16 µg/24h
IUS20 (Mirena)
Levonorgestrel IUS releasing 20 µg/24h

Who it enrols

Women with or without children in good general health and in need of contraception. Excludes pregnant/lactating women, recent delivery/abortion, previous ectopic pregnancy, pelvic infections, abnormal bleeding/uterine cavity, genital cancer, liver disease, or substance abuse.

Endpoints

Primary

Pearl Index3 years

Secondary

Number of Subjects With Total or Partial Expulsions3 years
Bleeding Pattern by 90-day Reference Periods3 years

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