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

November 16, 2025 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Taipei
      • Taipei City, Taipei, Taiwan, 110
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female individuals aged 20 years (inclusive) or older who have abnormal Pap smear results and have been diagnosed with CIN1 via colposcopy biopsy, and are also positive for high-risk HPV. This includes:
  • Patients with Pap smear results of CIN2, ASCUS, or CIN1 who have undergone colposcopic biopsy of suspicious lesions or random biopsies, with pathology confirming CIN1.
  • Patients with Pap smear results of CIN1 who have undergone colposcopic biopsy of suspicious lesions or random biopsies, and where the biopsy sample is insufficient for diagnosis or the biopsy pathology is normal.

Exclusion Criteria:

  • Female patients who are currently pregnant, planning to become pregnant, or are underage.
  • Patients with an allergy to the ingredients in CH2 Natural Purifying Protection Serum.
  • Patients diagnosed with CIN2, CIN3, or higher through colposcopic biopsy.
  • Patients with urinary tract or pelvic infections.
  • Patients with significantly impaired cognitive function.
  • Patients who are unable to self-administer vaginal gel.
  • Patients with immunocompromised conditions, end-stage liver or kidney disease, those using steroids, or those who have previously undergone total hysterectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
use vaginal hyaluronic acid gel as placebo
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
Experimental: CH2 vaginal gel
use CH2 vaginal gel as intervention 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: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pap smear result
Time Frame: up to 9 months
Thinprep smear every 3 months. The report from thinprep smear and coloposcope examination. Data will be categorized as CIN1, CIN2 and above, inflammation, normal.
up to 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HPV clearance rate
Time Frame: up to 9 months
Cervical swab for high risk HPV test
up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chi Hau Chen, National Taiwan University Hospsital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202405043RSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Intraepithelial Neoplasia

Clinical Trials on Placebo hyaluronic acid gel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings