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GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China

NCT00884260 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 918

Last updated 2014-08-21

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be performed.

Conditions

  • Contraception

Interventions

DRUG

Levonorgestrel IUS (LCS, BAY86-5028)

In Vitro release rate: 12µg LNG/24h

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Australia
  • China
  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00884260 on ClinicalTrials.gov