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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
918
In Vitro release rate: 12µg LNG/24h
Unnamed facility
Ashfield, New South Wales, Australia
Unnamed facility
Herston, Queensland, Australia
Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
Time frame: 3 years
LCS expulsion rate
Time frame: 3 years
Discontinuation rates
Time frame: 3 years
Adverse events
Time frame: 3 years
Laboratory tests
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Parkville, Victoria, Australia
Unnamed facility
Subiaco, Western Australia, Australia
Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Wuhan, Hubei, China
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Dalian, Liaoning, China
...and 15 more locations