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
Přehled studie
Postavení
Podmínky
Detailní popis
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
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Anyang, Čína
- An Yang Population and Family Planning Service Station
-
Lingbao, Čína
- Lingbao Population and Family Planning Service
-
Lushi, Čína
- Lushi Family Planning Technical Service Station
-
Shanghai, Čína
- Shanghai Institute of Planned Parenthood
-
Tongxiang, Čína
- Tongxiang Population and Family Planning Service Station
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pregnancy Pearl Index
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Pregnancy Pearl Index during the fifth year of Sino implant (II) use
Časové okno: 27 months
|
27 months
|
|
Total and free LNG plasma concentrations measured by a high-performance liquid chromatography with mass spectrometry assay
Časové okno: 27 months
|
27 months
|
|
Serum SHBG concentrations measured by a chemiluminescence immunoassay
Časové okno: 27 months
|
27 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Markus Steiner, Ph.D., FHI 360
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 458241-1
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .