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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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A study to assess the contraceptive effectiveness of Sino-implant (II).
Randomized trial to assess the contraceptive effectiveness of Sino-implant (II) and to compare levonorgestrel concentrations, safety and acceptability of Sino-implant (II) and Jadelle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jadelle | Experimental | Contraception using Jadelle implant |
|
| Sino-implant (II) | Active Comparator | levonorgestrel containing subdermal contraceptive implant [Zarin, Femplant, Trust or Simplant] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jadelle | Drug | LNG containing subdermal contraceptive implant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the contraceptive effectiveness of Sino-implant (II) during 4 years of use. | Pearl Index (number of pregnancies per 100 woman-years) over 4 years of use of Sino-implant (II). | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the contraceptive effectiveness of Sino-implant (II) during 5 years of use | Pearl Index over 5 years of use of Sino-implant (II) ; continuation & reasons for discontinuation in both groups. | 5 years |
| Compare concentrations of levonorgestrel through 5 years after insertion of Sino-implant (II) and Jadelle |
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Inclusion Criteria:• In good general health
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivian Brache, LIC | Profamilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profamilia | Santo Domingo | Dominican Republic |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Sino-implant (II) |
| Drug |
LNG containing subdermal contraceptive implant |
|
|
annual and cumulative probability of pregnancy during 5 years of use of Sino-implant (II); |
| 5 years |
| Compare pharmacokinetic profiles of Sino-implant (II) and Jadelle during the first 6 months of use in a sub-group of users undergoing intensive levonorgestrel sampling | The PK profile of LNG during the first 6 months post-insertion including the following parameters in a sub-group of users undergoing intensive LNG sampling: Mean LNG concentrations at 6 hours, 24 hours, 48 hours, 72 hours, 7 days and 90 days post-insertion Concentration-time profiles of LNG (individual and pooled) Maximal concentration (Cmax) and time to maximal concentration (Tmax) AUC0-7 days, AUC0-1mon, AUC0-3mon and AUC0-6mon | 5 years |
| Compare the safety and acceptability of Sino-implant (II) and Jadelle during 5 years of use | Adverse event rates in both treatment groups Annual and cumulative probability of early discontinuation in both treatment groups Reasons for discontinuation in both treatment groups Responses on acceptability questionnaires in both treatment groups | 5 years |
| Compare free levonorgestrel index through 5 years after insertion of Sino-implant (II) and Jadelle in a sub-group of approximately 150 users. | free levonorgestrel index, estimated as the ratio of levonorgestrel to sex hormone binding globulin at various point during 5 years of product use in a sub-group of approximately 150 women. | 5 years |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |