Persistent cervical human papillomavirus infection
Conditions
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Women aged between 18 and 65 years old (including the cut-off value) at the time of screening, who have a history of sexual life and are neither pregnant nor breastfeeding, must agree to have no pregnancy plans during the study period. 2. Patients who have been at high risk of HPV infection for more than 24 months without treatment or have not responded to treatment; 3. Vaginal discharge examination was normal, with no mold, trichomonas or clue cells. The tests for mycoplasma, chlamydia and Neisseria gonorrhoeae were negative. 4. TCT indicates no cervical lesion or LSIL. Colposcopy and cervical biopsy histopathological diagnosis suggest no lesion or grade I CIN. 5. Absence of genitalia (except for this disease) and the presence of other factors affecting clinical treatment; 6. Patients without other underlying diseases and who take medication regularly; 7. Patients who voluntarily participate in the trial and sign the informed consent form, provide informed consent for this treatment, can accept vaginal medication treatment as required by the trial, complete the medication course as prescribed by the doctor and attend follow-up visits on time, and those who agree to use condoms correctly throughout the study period as a barrier method and refrain from sexual activity during the treatment period; 8. No history of drug allergy; 9. No other treatment methods were used during the test period.
Exclusion criteria
Exclusion criteria: 1. Those with high-grade cervical lesions indicated by TCT, and those with high-grade lesions or cervical cancer indicated by colposcopy and cervical biopsy histopathological diagnosis; 2. If there are other unresolved vaginal/cervical diseases before administration, it may confuse the interpretation of clinical reactions (such as trichomonas vaginitis, mycotic vaginitis, bacterial vaginitis, positive mycoplasma, positive chlamydia, positive Neisseria gonorrhoeae or severe vulvar pruritus, as well as common sexually transmitted diseases such as gonorrhea, genital herpes, syphilis, etc.). 3. Patients who have received vaginal administration within 2 weeks or are currently undergoing treatment; 4. Patients who have undergone surgery for cervical intraepithelial neoplasia, patients with cervical and uterus-related lesions, including those with condyloma acuminatum, cervical polyps, cervical neoplasms, cervical fibroids, cervical cancer, etc., as well as those who have undergone total hysterectomy due to benign diseases in the past or have a history of malignant tumors that the researchers consider to affect the evaluation of the trial; 5. Those with damaged mucous membranes of the vulva and vaginal walls; 6. Women in the preconception period, pregnancy and lactation period; 7. Concurrent acute or chronic pelvic inflammatory disease, urinary tract infection and other infectious diseases that require systematic treatment, or the presence of other active infections that need systematic treatment; 8. Patients who have participated in other clinical trials within the past 3 to 6 months; 9. Patients with allergic constitutions and those allergic to the test drugs; For patients who have received radiotherapy or chemotherapy, drugs that affect immune function (such as systemic steroids or immunomodulatory drugs, except interferon) have been used within 3 months before screening. 10. For patients who have received radiotherapy or chemotherapy, drugs that affect immune function (such as systemic steroids or immunomodulatory drugs, except interferon) have been used within 3 months before screening. 11. Subjects with severe underlying diseases, such as cardiovascular, lung, liver, kidney, gastrointestinal, blood, endocrine, metabolic, neurological, mental or other diseases, which the researchers consider to affect the evaluation of the trial; 12. Patients with immune system diseases or malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HPV negative conversion rate; | — |
Countries
China
Contacts
Public ContactJinyi Tong
Hangzhou First People's Hospital
Outcome results
None listed