Status:
ACTIVE_NOT_RECRUITING
Comparisons of the Effects and Clinical Outcomes of CH2 Vaginal Gel Versus Placebo on CIN1
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Cervical Intraepithelial Neoplasia
Human Papillomavirus
Eligibility:
FEMALE
20+ years
Phase:
NA
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 25/100,000 person in 1995 to 7.0/100,1000 perso...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06582004
Start Date
September 30 2024
End Date
December 1 2026
Last Update
November 19 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei City, Taipei, Taiwan, 110