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Contraceptive Effectiveness of Sino-implant (II) in China

16 février 2016 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

La contraception

Description détaillée

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

Type d'étude

Observationnel

Inscription (Réel)

538

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans à 44 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Pregnancy Pearl Index Délai: 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

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

FHI 360

Collaborateurs

Bill and Melinda Gates Foundation

Les enquêteurs

Chercheur principal: Markus Steiner, Ph.D., FHI 360

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2013

Achèvement primaire (Réel)

1 novembre 2015

Achèvement de l'étude (Réel)

1 janvier 2016

Dates d'inscription aux études

Première soumission

3 septembre 2013

Première soumission répondant aux critères de contrôle qualité