NCT06582004

Comparisons of the Effects and Clinical Outcomes of CH2 Vaginal Gel Versus Placebo on CIN1

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: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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 25/100,000 person in 1995 to 7.0/100,1000 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. 82.9 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). 82.9% 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.

Conditions

• Cervical Intraepithelial Neoplasia
• Human Papillomavirus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CH2 vaginal gel	The usage frequency is 2 units per week, with a 3-day interval between each unit, for a total duration of 24 weeks
DIETARY_SUPPLEMENT	Placebo hyaluronic acid gel	The usage frequency is 2 units per week, with a 3-day interval between each unit, for a total duration of 24 weeks

Timeline

• Start date: 2024-09-30
• Primary completion: 2026-01-01
• Completion: 2026-12-01
• First posted: 2024-09-03
• Last updated: 2025-11-19

Locations

1 site across 1 country: Taiwan