Trial intelligence / Profile preview

LCS12 vs Etonorgestrel Implant for Contraception

NCT01397097Phase 3

Key facts

Status: Completed
Start: Sep 2011
Primary completion: Jun 2013
Countries: 6
Sponsor: Bayer
Modality: Small Molecules

Drugs: levonorgestrel intrauterine system
Conditions: contraception

Overview

Phase 3, randomised, open-label trial of levonorgestrel intrauterine system in contraception (2 arms), sponsored by Bayer. Primary endpoint: Discontinuation rate by treatment group at 12 months. Started Sep 2011; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

LCS12 (Skyla)
Levonorgestrel IUS (LCS12)
Etonorgestrel Implant
Etonorgestrel subdermal implant (Nexplanon)

Who it enrols

Healthy women 18-35 years of age in need of contraception, with regular menstrual cycles and no history of significant gynecological or systemic diseases.

Endpoints

Primary

Discontinuation rate by treatment group12 months

Secondary

Discontinuation rates by treatment group6 months
Overall satisfaction rating and questionnaires on User satisfaction and bleeding and Contraceptive tolerability12 months
Pregnancy rate, as determined by Pearl index12 months
Bleeding patterns12 months
Adverse event profile12 months

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