Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263582
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-02-08
Brief Title:
Pharmacokinetics of Intravaginal Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Pharmacokinetics of Intravaginal Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigates the pharmacokinetics of Artesunate AS and dihydroartemisinin DHA the active metabolite of Artesunate following intravaginal use at the dosing and frequency being studied for cervical precancer treatment A secondary objective is to investigate safety among study participants
Detailed Description:
Due to lack of access to primary and secondary prevention women living in low-and middle-income countries bear a disproportionate burden of cervical cancer accounting for 90 of new cases and 85 of deaths globally Cervical cancer can be prevented through vaccination against Human papillomavirus HPV whose infection is required to develop cervical cancer Among unvaccinated women screening for HPV or cervical precancer allows identification of precancerous lesions - primarily cervical intraepithelial neoplasia grade 2 or 3 CIN23 that can be treated and cured to prevent progression to cancer Most CIN23 lesions that are left untreated will progress to invasive cervical cancer Current treatments for CIN23 in both high- and low-resource countries LMICs require trained health care providers who are often out of reach for many women particularly in rural areas in LMICs Lack of access to precancer treatment following screening in LMICs in part accounts for the high burden of incident cervical cancer Preclinical data have demonstrated pro-apoptotic effects of Artesunate AS a commonly available drug with an excellent safety profile in oral rectal and intravenous routes primarily used to treat malaria in LMICs This led to a recent Phase I study in the United States that demonstrated that self-administered vaginal artesunate inserts pessaries are safe well-tolerated and demonstrate efficacy for treatment of CIN23 Based on the mechanism of action the clinical safety profile and widespread availability as a generic drug on the World Health Organization WHO List of Essential Medications vaginal artesunate inserts pessaries if backed by data from randomized trials may offer patient-controlled and access cervical precancer treatment method for women in LMICs who face the greatest burden of cervical cancer and have difficulty accessing skilled providers for precancer treatment However given that artesunate is a well-known drug used in malaria treatment it is critical to ensure that vaginal application of the drug will not promote resistance for use in malaria treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None