Cervical Intraepithelial NeoplasiaNCT06582004
Comparisons of the Effects and Clinical Outcomes of CH2 Vaginal Gel Versus Placebo on CIN1
A study testing CH2 vaginal gel in people with Cervical Intraepithelial Neoplasia and Human Papillomavirus, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Human Papillomavirus
- What is being tested?
- CH2 vaginal gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- CH2 vaginal gel, Placebo hyaluronic acid gel
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CH2 vaginal gelDietary supplement
The usage frequency is 2 units per week, with a 3-day interval between each unit, for a total duration of 24 weeks
Placebo hyaluronic acid gelDietary supplement
The usage frequency is 2 units per week, with a 3-day interval between each unit, for a total duration of 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | use vaginal hyaluronic acid gel as placebo Receives: Dietary Supplement: Placebo hyaluronic acid gel |
| CH2 vaginal gel | Experimental | 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 Receives: Dietary Supplement: CH2 vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
pap smear result
Thinprep smear every 3 months. The report from thinprep smear and coloposcope examination. Data will be categorized as CIN1, CIN2 and above, inflammation, normal.
Measured: up to 9 months
Secondary outcomes (1)
HPV clearance rate
Cervical swab for high risk HPV test
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start30 Sep 2024
- Primary completionJan 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi Hau Chen, Principal investigator, National Taiwan University Hospsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582004
- Sponsor's protocol ID
- 202405043RSD
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06582004
- Acronym / sponsor ID
- 202405043RSD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo hyaluronic acid geluse vaginal hyaluronic acid gel as placebo |
| CH2 vaginal gel | Experimental | Dietary Supplement: CH2 vaginal geluse 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CH2 vaginal gelThe 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 |
| Placebo hyaluronic acid gelThe 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 |
Primary outcome
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.
1 secondary outcome
HPV clearance rate
Time frame: up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Hau Chen principal investigator
National Taiwan University Hospsital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CH2 vaginal gel in people with Cervical Intraepithelial Neoplasia and Human Papillomavirus, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pap smear result (time frame: up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.