Contraceptive Effectiveness of Sino-implant (II) in China

NCT01936454 | Completed

• 1 other identifier: 458241-1
• Study Type: observational
• Target: 538
• Locations: 1 country
• Sites: 5

Brief Summary

A cohort study to Evaluate the contraceptive effectiveness of Sino-implant (II) during the 3rd and 4th years of use in Chinese women

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (4)

Cohort 1

n=20 women with insertion dates 3-5months prior to enrollment and followed for 2-6 months

Cohort 2

n=20 women with insertion dates 9-11 months prior to enrollment and followed for 2-6 months

Cohort 3

n=250 women with insertion dates 21-24 months prior to enrollment and followed through month 36

Cohort 4

n=300 women with insertion dates 33-36 months prior to enrollment and followed through month 6

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study Population: Women who have received contraceptive implants from the Tongxiang, An Yang, Lingbao, and Lushi Family Planning Service Stations.

You may qualify if:

• Have a confirmed Sino-implant (II) set in place;
• Have a confirmed contraceptive implant insertion date consistent with the criteria for the cohort she is to be enrolled in;
• Be aged between 20 and 44 years, inclusive;
• Not wish to become pregnant in the next year;
• No desire to get implant removal within the next year;
• Be able to understand the information given to them and to make personal decisions on whether to participate or not in the study;
• Consent to participation and sign an informed consent form;
• Agree and be able to return to the clinic for follow-up visit(s).

You may not qualify if:

• Acute liver disease or cirrhosis by self-report;
• Benign or malignant tumor of the liver by self-report;
• Use of rifampicin, and/or anticonvulsants (barbiturates, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone, topiramate), and/or herbal products containing St. John's wort (Hypericum perforatum) by self-report;7
• Use of medications containing LNG or other hormones that impact LNG or SHBG disposition, e.g. treatment with LNG or oral contraceptives for bleeding disturbances by self-report;
• Known HIV-positive status by self-report;
• Any condition (social or medical) which in the opinion of the Investigator would make study participation unsafe, would interfere with adherence to study requirements, or complicate data interpretation.

Sponsors & Collaborators

• FHI 360: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (5)

An Yang Population and Family Planning Service Station

Anyang, China

Location

Lingbao Population and Family Planning Service

Lingbao, China

Location

Lushi Family Planning Technical Service Station

Lushi, China

Location

Shanghai Institute of Planned Parenthood

Shanghai, China

Location

Tongxiang Population and Family Planning Service Station

Tongxiang, China

Location

Study Officials

• Markus Steiner, Ph.D.

  FHI 360

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 6, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

CN (5)