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Contraceptive Effectiveness of Sino-implant (II) in China

16 februari 2016 bijgewerkt door: FHI 360

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

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

Studie Overzicht

Toestand

Voltooid

Conditie

Anticonceptie

Gedetailleerde beschrijving

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:

To evaluate the contraceptive effectiveness of Sino-implant (II) during the fifth year of use.
To characterize the total and free levonorgestrel (LNG) plasma concentration-time profiles over five years following Sino-implant (II) insertion
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

Studietype

Observationeel

Inschrijving (Werkelijk)

538

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

China
- - Anyang, China
    - An Yang Population and Family Planning Service Station
  - Lingbao, China
    - Lingbao Population and Family Planning Service
  - Lushi, China
    - Lushi Family Planning Technical Service Station
  - Shanghai, China
    - Shanghai Institute of Planned Parenthood
  - Tongxiang, China
    - Tongxiang Population and Family Planning Service Station

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 44 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Pregnancy Pearl Index Tijdsspanne: 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	27 months

Secundaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
Pregnancy Pearl Index during the fifth year of Sino implant (II) use Tijdsspanne: 27 months	27 months
Total and free LNG plasma concentrations measured by a high-performance liquid chromatography with mass spectrometry assay Tijdsspanne: 27 months	27 months
Serum SHBG concentrations measured by a chemiluminescence immunoassay Tijdsspanne: 27 months	27 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

FHI 360

Medewerkers

Bill and Melinda Gates Foundation

Onderzoekers

Hoofdonderzoeker: Markus Steiner, Ph.D., FHI 360

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2013

Primaire voltooiing (Werkelijk)

1 november 2015

Studie voltooiing (Werkelijk)

1 januari 2016

Studieregistratiedata

Eerst ingediend

3 september 2013

Eerst ingediend dat voldeed aan de QC-criteria