Clinical trial NCT05863975: Treatment of HPV Infection in Perimenopausal and Postmenopausal Women
Official title: Therapeutic Effect of Topical Estrogen and Human Interferon Alpha 2b Vaginal Effervescent Capsules in Perimenopausal and Postmenopausal Women With High-risk HPV Infection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: HPV Infection
Keywords: Perimenopause
postmenopausal
HPV infection
treatment
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: HPV negative conversion rate
timeFrame: 1 month and 1 year after drug discontinuation
Secondary outcomes:
measure: Vaginal microecological improvement
timeFrame: 1 week after drug discontinuation
Other outcomes:
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Study officials:
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