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Trial Title:
Treatment of HPV Infection in Perimenopausal and Postmenopausal Women
NCT ID:
NCT05863975
Condition:
HPV Infection
Conditions: Official terms:
Infections
Communicable Diseases
Papillomavirus Infections
Interferons
Interferon-alpha
Interferon alpha-2
Conditions: Keywords:
Perimenopause
postmenopausal
HPV infection
treatment
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Human interferon alpha 2b vaginal Effervescent capsules
Description:
①Interferon group: human interferon alpha 2b vaginal effervescent capsule vaginal
medication. ② Promestriene group: promestriene cream vaginal medication. ③Interferon +
promestriene combination group: two drugs were given in combination.
Arm group label:
Interferon + promestriene combination group
Arm group label:
Interferon group
Arm group label:
Promestriene group
Other name:
Promestriene cream
Other name:
Human interferon alpha 2b vaginal Effervescent capsules+Proestradiene cream
Summary:
A randomized controlled study was conducted to determine the effects of vaginal estrogen
and human interferon alpha 2b vaginal effervescent capsules on vaginal microecology in
perimenopausal and postmenopausal women. To determine whether there is a synergistic
effect between the two in the treatment of HPV infection in perimenopausal and
postmenopausal women. To observe the effects of two drugs alone and combined on the
vaginal immune environment of patients.
Detailed description:
After pre-enrollment screening, patients who met the inclusion criteria signed informed
consent and were divided into interferon group, promestriene group and interferon +
promestriene combination group according to the randomized controlled number table.
① Interferon group: human interferon alpha 2b vaginal effervescent capsules were given
vaginal medication, one capsule a day for 10 days, for a course of treatment, a total of
3 courses of treatment. ② Promestriene group: Promestriene cream vaginal medication, once
a day, 0.1g each time, 10 days, for a course of treatment, a total of 3 courses of
treatment. ③Interferon + promestriene combination group: interferon 1 grain +
promestriene cream 0.1g, vaginal medication, once a day, continuous use for 10 days, for
a course of treatment, continuous use of 3 courses of treatment. Vaginal secretions were
collected before treatment and one week after treatment to detect vaginal microecology.
Flow cytometry was used to detect the proportion of immune cells in vaginal secretion.
ELISA was used to detect immune-related cytokines (IFN-γ, TNF-α, IL-2, IL-4, IL-6, IL-10)
in vaginal secretions.
HPV was reviewed at 1 month and 1 year after drug cessation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The age of 45-65 years (inclusive);
- HPV test indicates positive cervical and vaginal high-risk HPV;
- Cervical HSIL was excluded according to the 2015 US Transitional Clinical
Guidelines for Cervical Cancer Screening.
- Patients with high-grade cervical intraepithelial lesions, who have
undergone cervical conotomy or have undergone total or subtotal
hysterectomy in the past, and HPV tests indicate high-risk cervical
and vaginal HPV infection;
- If the combination of clear vaginal inflammation, symptomatic
treatment is needed, then the group test;
- If the patients were complicated with abnormal uterine
bleeding or postmenstrual bleeding, the reproductive system
tumor should be excluded and cured, and then the patients
were re-enrolled.
⑦ Volunteer to participate in clinical studies and sign
informed consent.
Exclusion Criteria:
- Allergic to human interferon alpha 2b vaginal effervescent capsules or prolestrene
cream;
- Pregnant or lactating patients;
- Patients with abnormal vaginal bleeding without clear cause;
④Patients with cervical high-grade intraepithelial lesions, gynecological
malignancies, serious heart, brain, kidney, immune, blood and other
systems and psychiatric neuropsychological diseases;
⑤Patients with consciousness disorder and communication disorder can not
cooperate with the experiment;
⑥ Patients considered unsuitable or refused to participate in this
clinical trial.
Gender:
Female
Gender based:
Yes
Minimum age:
45 Years
Maximum age:
60 Years
Healthy volunteers:
No
Start date:
July 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Qianfoshan Hospital
Agency class:
Other
Source:
Qianfoshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05863975
