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Contraceptive Effectiveness of Sino-implant (II) in China

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ClinicalTrials.gov Identifier: NCT01936454
Recruitment Status : Completed
First Posted : September 6, 2013
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
FHI 360

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

Condition or disease
Contraception

Detailed Description:

A Study to Evaluate the Contraceptive Effectiveness during the Third, Fourth and Fifth Year of Sino-implant (II)Use and the Pharmacokinetics (PK) over Five Years of use in Chinese Women

Population: A total of 590 Chinese Sino-Implant (II) users between 20and 44 years of age enrolled in one of four prospective cohorts:

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

Study Duration: 33 total months in the field: 3 months of participant recruitment(all cohorts); up to 27 months of pregnancy monitoring and PK blood sampling in Cohort 4 (up to 15 months in Cohort 3 and 6 months in Cohort 1 and Cohort 2);and 3 months of close-out activities.

For secondary PK outcomes, blood samples will be taken 2 to 6 months apart from each woman in Cohort 1 and Cohort 2; at enrollment, month 30 and month 36 from the first 20 consenting women in Cohort 3; and at enrollment and months 42, 48, 54, and 60 from the first 30 consenting women in Cohort 4.

Primary Objective: To evaluate the contraceptive effectiveness of Sino-implant (II) during the third and fourth years of use

Secondary Objectives:

  1. To evaluate the contraceptive effectiveness of Sino-implant (II) during the fifth year of use.
  2. To characterize the total and free levonorgestrel (LNG) plasma concentration-time profiles over five years following Sino-implant (II) insertion
  3. To characterize the sex hormone binding globulin (SHBG) serum concentration-time profile and its relationship to total LNG levels over five years following Sino-implant (II) insertion

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Study Type : Observational
Actual Enrollment : 538 participants
Time Perspective: Prospective
Official Title: 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
Study Start Date : July 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

Group/Cohort
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



Primary Outcome Measures :
  1. Pregnancy Pearl Index [ Time Frame: 27 months ]
    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


Secondary Outcome Measures :
  1. Pregnancy Pearl Index during the fifth year of Sino implant (II) use [ Time Frame: 27 months ]
  2. Total and free LNG plasma concentrations measured by a high-performance liquid chromatography with mass spectrometry assay [ Time Frame: 27 months ]
  3. Serum SHBG concentrations measured by a chemiluminescence immunoassay [ Time Frame: 27 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936454


Locations
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China
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
Sponsors and Collaborators
FHI 360
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Markus Steiner, Ph.D. FHI 360
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Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01936454    
Other Study ID Numbers: 458241-1
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided