A Study to Evaluate the Contraceptive Effectiveness During the Third, Fourth and Fifth Year of Sino-implant (II) Use and the Pharmacokinetics Over Five Years of Use in Chinese Women
Sponsor study identifier
observational
538
1 country
5
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Actual (reported)Study Completion
January 2016
Actual (reported)A cohort study to Evaluate the contraceptive effectiveness of Sino-implant (II) during the 3rd and 4th years of use in Chinese women
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 3, 2013
Actual (reported)September 6, 2013
Actual (reported)November 2015
Actual (reported)January 2016
Actual (reported)Pregnancy Pearl Index
Pregnancy Pearl Index (number of pregnancies per 100 woman-years) during the third and fourth years of use, respectively, in Cohort 3 and Cohort 4
27 months
Pregnancy Pearl Index during the fifth year of Sino implant (II) use
27 months
Total and free LNG plasma concentrations measured by a high-performance liquid chromatography with mass spectrometry assay
27 months
Serum SHBG concentrations measured by a chemiluminescence immunoassay
27 months
n=20 women with insertion dates 3-5months prior to enrollment and followed for 2-6 months
n=20 women with insertion dates 9-11 months prior to enrollment and followed for 2-6 months
n=250 women with insertion dates 21-24 months prior to enrollment and followed through month 36
n=300 women with insertion dates 33-36 months prior to enrollment and followed through month 6
Study Population: Women who have received contraceptive implants from the Tongxiang, An Yang, Lingbao, and Lushi Family Planning Service Stations.
An Yang Population and Family Planning Service Station
Anyang, China
Lingbao Population and Family Planning Service
Lingbao, China
Lushi Family Planning Technical Service Station
Lushi, China
Shanghai Institute of Planned Parenthood
Shanghai, China
Tongxiang Population and Family Planning Service Station
Tongxiang, China
Markus Steiner, Ph.D.
FHI 360
538 participants (actual enrollment reported by the registry).
First Submitted
September 3, 2013
First Posted
September 6, 2013
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Bleeding Pattern Difference Between Levonorgestrel Intrauterine System (LNG-IUS) and Copper Intrauterine Devices (IUDs) Immediately Inserted After Abortion
Contact the study team to confirm eligibility.
Primary Completion
November 2015
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
February 17, 2016
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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