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Last Updated: May 26, 2022

CLINICAL TRIALS PROFILE FOR JADELLE


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All Clinical Trials for Jadelle

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01594632 ↗ Safety,Effectiveness and Acceptability of Sino-implant II in DR Completed Bill and Melinda Gates Foundation N/A 2011-01-01 A study to assess the contraceptive effectiveness of Sino-implant (II).
NCT01594632 ↗ Safety,Effectiveness and Acceptability of Sino-implant II in DR Completed FHI 360 N/A 2011-01-01 A study to assess the contraceptive effectiveness of Sino-implant (II).
NCT01789879 ↗ A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 2013-06-01 The use of hormone contraception poses a significant challenge for the estimated 16 million HIV-infected women of childbearing age. This is due to known drug interactions with antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel subdermal implant, the most widely available hormone implant in low and middle-income countries, this study will translate its findings into an evidence-based approach to co-manage these important medications. The investigators hypothesize that women receiving nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the mean levonorgestrel plasma concentration measured six months after the implant's insertion as compared to those women who are not taking antiretroviral therapy. Although the implant's efficacy may be retained initially, the investigators propose that a decrease in levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the implant's effectiveness near the end of its intended duration of use (5 years).
NCT01789879 ↗ A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy Completed Makerere University Phase 2 2013-06-01 The use of hormone contraception poses a significant challenge for the estimated 16 million HIV-infected women of childbearing age. This is due to known drug interactions with antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel subdermal implant, the most widely available hormone implant in low and middle-income countries, this study will translate its findings into an evidence-based approach to co-manage these important medications. The investigators hypothesize that women receiving nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the mean levonorgestrel plasma concentration measured six months after the implant's insertion as compared to those women who are not taking antiretroviral therapy. Although the implant's efficacy may be retained initially, the investigators propose that a decrease in levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the implant's effectiveness near the end of its intended duration of use (5 years).
NCT01789879 ↗ A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy Completed University of Liverpool Phase 2 2013-06-01 The use of hormone contraception poses a significant challenge for the estimated 16 million HIV-infected women of childbearing age. This is due to known drug interactions with antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel subdermal implant, the most widely available hormone implant in low and middle-income countries, this study will translate its findings into an evidence-based approach to co-manage these important medications. The investigators hypothesize that women receiving nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the mean levonorgestrel plasma concentration measured six months after the implant's insertion as compared to those women who are not taking antiretroviral therapy. Although the implant's efficacy may be retained initially, the investigators propose that a decrease in levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the implant's effectiveness near the end of its intended duration of use (5 years).
NCT01789879 ↗ A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy Completed University of Nebraska Phase 2 2013-06-01 The use of hormone contraception poses a significant challenge for the estimated 16 million HIV-infected women of childbearing age. This is due to known drug interactions with antiretroviral therapy (medicines used to treat HIV) that may jeopardize contraception effectiveness. By evaluating the impact of antiretroviral therapy on a levonorgestrel subdermal implant, the most widely available hormone implant in low and middle-income countries, this study will translate its findings into an evidence-based approach to co-manage these important medications. The investigators hypothesize that women receiving nevirapine or efavirenz-based antiretroviral therapy will have a significant decrease in the mean levonorgestrel plasma concentration measured six months after the implant's insertion as compared to those women who are not taking antiretroviral therapy. Although the implant's efficacy may be retained initially, the investigators propose that a decrease in levonorgestrel concentrations in women receiving antiretroviral therapy may jeopardize the implant's effectiveness near the end of its intended duration of use (5 years).
NCT02038335 ↗ HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC Completed University of Zimbabwe 2014-02-01 This study is being done to understand if using birth control causes changes in the immune cells within the reproductive tract of healthy women. Immune cells are important because they help prevent infections from starting and help fight infections that have started. Immune cells are also the type of cells that HIV (human immunodeficiency virus) infects so understanding more about them will help to better understand how to prevent the spread of HIV. Immune cells will be studied from the reproductive tract of women who want to start using one of the following contraceptives: Depo-Provera (DMPA), NET-EN, MPA/E2 (Cyclofem®), the levonorgestrel subdermal implant (Jadelle® ), the etonogestrel subdermal implant (Implanon® or Nexplanon® ) and the copper IUD.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Jadelle

Condition Name

Condition Name for Jadelle
Intervention Trials
Contraception 6
HIV 4
Breastfeeding 1
HIV-1-infection 1
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Condition MeSH

Condition MeSH for Jadelle
Intervention Trials
Uterine Hemorrhage 1
Hemorrhage 1
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Clinical Trial Locations for Jadelle

Trials by Country

Trials by Country for Jadelle
Location Trials
Uganda 3
Thailand 2
Dominican Republic 1
Malawi 1
Zimbabwe 1
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Clinical Trial Progress for Jadelle

Clinical Trial Phase

Clinical Trial Phase for Jadelle
Clinical Trial Phase Trials
Phase 4 2
Phase 2 3
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Jadelle
Clinical Trial Phase Trials
Completed 6
Unknown status 2
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Clinical Trial Sponsors for Jadelle

Sponsor Name

Sponsor Name for Jadelle
Sponsor Trials
University of Liverpool 3
University of Nebraska 3
Bill and Melinda Gates Foundation 2
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Sponsor Type

Sponsor Type for Jadelle
Sponsor Trials
Other 18
NIH 5
U.S. Fed 2
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Dow
Colorcon
Johnson and Johnson

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