CLINICAL TRIALS PROFILE FOR JADELLE

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).

Clinical Trial Conditions for JADELLE

Condition Name

Condition Name for JADELLE
Intervention	Trials
Contraception	6
HIV	4
Microbiota	1
Post Partum	1

Condition MeSH

Condition MeSH for JADELLE
Intervention	Trials
Uterine Hemorrhage	1
Hemorrhage	1

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

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

Clinical Trial Status

Clinical Trial Status for JADELLE
Clinical Trial Phase	Trials
Completed	6
Unknown status	2

Clinical Trial Sponsors for JADELLE

Sponsor Name

Sponsor Name for JADELLE
Sponsor	Trials
University of Liverpool	3
University of Nebraska	3
Makerere University	2

Sponsor Type

Sponsor Type for JADELLE
Sponsor	Trials
Other	18
NIH	5
U.S. Fed	2