Contraceptive Effectiveness of Sino-implant (II) in China
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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Anyang, Porcelana
- An Yang Population and Family Planning Service Station
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Lingbao, Porcelana
- Lingbao Population and Family Planning Service
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Lushi, Porcelana
- Lushi Family Planning Technical Service Station
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Shanghai, Porcelana
- Shanghai Institute of Planned Parenthood
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Tongxiang, Porcelana
- Tongxiang Population and Family Planning Service Station
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Cohort 1
n=20 women with insertion dates 3-5months prior to enrollment and followed for 2-6 months
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Cohort 2
n=20 women with insertion dates 9-11 months prior to enrollment and followed for 2-6 months
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Cohort 3
n=250 women with insertion dates 21-24 months prior to enrollment and followed through month 36
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Cohort 4
n=300 women with insertion dates 33-36 months prior to enrollment and followed through month 6
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pregnancy Pearl Index
Periodo de tiempo: 27 months
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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
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27 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Pregnancy Pearl Index during the fifth year of Sino implant (II) use
Periodo de tiempo: 27 months
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27 months
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Total and free LNG plasma concentrations measured by a high-performance liquid chromatography with mass spectrometry assay
Periodo de tiempo: 27 months
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27 months
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Serum SHBG concentrations measured by a chemiluminescence immunoassay
Periodo de tiempo: 27 months
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27 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Markus Steiner, Ph.D., FHI 360
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 458241-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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