Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582004
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Comparisons of the Effects and Clinical Outcomes of CH2 Vaginal Gel Versus Placebo on CIN1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparisons of the Effects and Clinical Outcomes of CH2 Vaginal Gel Versus Placebo on CIN1 with High-risk HPV Patients a Prospective Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In Taiwan Pap smear screen has been offered every year for women over 30 years old since 1995 The incidence of cervical invasive cancer decreased from 25100000 person in 1995 to 701001000 person in 2016 In contrast the incidence of pre-cancerous lesions increased gradually According to ASCCP observation and repeated cytology in 6-12 months is recommended in colposcopy-diagnosed CIN1 patients Most of the low-grade lesions regressed spontaneously without treatment 49 percent of CIN1 regressed to negative in six months and 70 percent regressed in 12 months
Emerging evidence suggests associations between the composition of the vaginal microbiota VMB human papillomavirus HPV infection and cervical intraepithelial neoplasia CIN Previous research included 87 patients with untreated CIN2 It reported that patients with a Lactobacillus-dominant microbiome at baseline are more likely to have regressive disease at 12 months Lactobacillus spp depletion and presence of specific anaerobic taxa are associated with CIN2 persistence and slower regression 829 percent of women with low-grade squamous intraepithelial lesions LSIL tested positive for HPV CH2 vaginal gel is a marketed health product derived from natural ingredients including water probiotic glycerol and plant extracts Investigators have designed this trial to compare the following outcomes between participants who use and those who use placebo 1 the regression rate of CIN1 2 the time to regression of CIN1 and 3 the HPV clearance rate in participants
Emerging evidence suggests associations between the composition of the vaginal microbiota VMB human papillomavirus HPV infection and cervical intraepithelial neoplasia CIN Previous research included 87 patients with untreated CIN2 It reported that patients with a Lactobacillus-dominant microbiome at baseline are more likely to have regressive disease at 12 months Lactobacillus spp depletion and presence of specific anaerobic taxa are associated with CIN2 persistence and slower regression 829 percent of women with low-grade squamous intraepithelial lesions LSIL tested positive for HPV CH2 vaginal gel is a marketed health product derived from natural ingredients including water probiotic glycerol and plant extracts Investigators have designed this trial to compare the following outcomes between participants who use and those who use placebo 1 the regression rate of CIN1 2 the time to regression of CIN1 and 3 the HPV clearance rate in participants
Detailed Description:
Emerging evidence suggests associations between the composition of the vaginal microbiota VMB human papillomavirus HPV infection and cervical intraepithelial neoplasia CIN 829 of women with CIN1 tested positive for HPV CH2 vaginal gel is a marketed health product derived from natural ingredients including water probiotic glycerol and plant extracts The hypothesis is that this product will improve the vaginal environment and microbiota leading to increased HPV clearance and enhancing the regression rate of CIN1 Investigators have designed this trial to compare outcomes between participants who use CH2 and those who use placebo
Patients and Methods
Investigators will conduct a prospective randomized controlled study to enroll 50 participants with CIN1 from the Gynecologic colposcopy clinic of National Taiwan University Hospital Participants will be randomly assigned to receive either CH2 vaginal gel or none All enrolled patients will be assessed before use at three months post-use and at six months post-use including questionnaire surveys ThinPrep Pap tests and HPV genotyping
Patients and Methods
Investigators will conduct a prospective randomized controlled study to enroll 50 participants with CIN1 from the Gynecologic colposcopy clinic of National Taiwan University Hospital Participants will be randomly assigned to receive either CH2 vaginal gel or none All enrolled patients will be assessed before use at three months post-use and at six months post-use including questionnaire surveys ThinPrep Pap tests and HPV genotyping
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None