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Contraceptive Effectiveness of Sino-implant (II) in China

16. Februar 2016 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Empfängnisverhütung

Detaillierte Beschreibung

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

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

538

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 44 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Gruppen / Kohorten

Kohorten und Interventionen

Gruppe / Kohorte
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Pregnancy Pearl Index Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

FHI 360

Mitarbeiter

Bill and Melinda Gates Foundation

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2013

Primärer Abschluss (Tatsächlich)

1. November 2015

Studienabschluss (Tatsächlich)

1. Januar 2016

Studienanmeldedaten

Zuerst eingereicht

3. September 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat