Contraceptive Effectiveness of Sino-implant (II) in China

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936454
• Other study ID #: 458241-1
• Status: Completed
• Phase: N/A
• First received: September 3, 2013
• Last updated: February 16, 2016
• Start date: July 2013
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 44 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pregnancy Pearl Index during the fifth year of Sino implant (II) use		27 months	No
Secondary	Total and free LNG plasma concentrations measured by a high-performance liquid chromatography with mass spectrometry assay		27 months	No
Secondary	Serum SHBG concentrations measured by a chemiluminescence immunoassay		27 months	No