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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Anyang, Cina
- An Yang Population and Family Planning Service Station
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Lingbao, Cina
- Lingbao Population and Family Planning Service
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Lushi, Cina
- Lushi Family Planning Technical Service Station
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Shanghai, Cina
- Shanghai Institute of Planned Parenthood
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Tongxiang, Cina
- Tongxiang Population and Family Planning Service Station
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pregnancy Pearl Index
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Pregnancy Pearl Index during the fifth year of Sino implant (II) use
Lasso di tempo: 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
Lasso di tempo: 27 months
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27 months
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Serum SHBG concentrations measured by a chemiluminescence immunoassay
Lasso di tempo: 27 months
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27 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Markus Steiner, Ph.D., FHI 360
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 458241-1
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