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Treatment of HPV Infection in Perimenopausal and Postmenopausal Women

Primary Purpose

HPV Infection

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Human interferon alpha 2b vaginal Effervescent capsules
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HPV Infection focused on measuring Perimenopause, postmenopausal, HPV infection, treatment

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Interferon group

    Promestriene group

    Interferon + promestriene combination group

    Arm Description

    Vaginal placement of human interferon alpha 2b vaginal effervescent capsules, one pill a day daily, 10 days, for a course of treatment, a total of 3 courses

    promestriene cream vaginal medication, once a day, 1g each time, 10 days, for a course of treatment, a total of 3 courses of treatment

    given one human interferon alpha 2b vaginal effervescent capsule vaginal placement + promestriene cream 1g vaginal medication, once a day, for 10 days, for a course of 1, 3 courses of continuous use.

    Outcomes

    Primary Outcome Measures

    HPV negative conversion rate
    Number of cases of HPV negative conversion after medication/total cases ×100%

    Secondary Outcome Measures

    Vaginal microecological improvement
    Concentration and diversity of vaginal microflora after drug treatment

    Full Information

    First Posted
    March 26, 2023
    Last Updated
    May 8, 2023
    Sponsor
    Qianfoshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05863975
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Qianfoshan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HPV Infection
    Keywords
    Perimenopause, postmenopausal, HPV infection, treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Sequential Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Interferon group
    Arm Type
    Experimental
    Arm Description
    Vaginal placement of human interferon alpha 2b vaginal effervescent capsules, one pill a day daily, 10 days, for a course of treatment, a total of 3 courses
    Arm Title
    Promestriene group
    Arm Type
    Experimental
    Arm Description
    promestriene cream vaginal medication, once a day, 1g each time, 10 days, for a course of treatment, a total of 3 courses of treatment
    Arm Title
    Interferon + promestriene combination group
    Arm Type
    Experimental
    Arm Description
    given one human interferon alpha 2b vaginal effervescent capsule vaginal placement + promestriene cream 1g vaginal medication, once a day, for 10 days, for a course of 1, 3 courses of continuous use.
    Intervention Type
    Drug
    Intervention Name(s)
    Human interferon alpha 2b vaginal Effervescent capsules
    Other Intervention Name(s)
    Promestriene cream, Human interferon alpha 2b vaginal Effervescent capsules+Proestradiene cream
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    HPV negative conversion rate
    Description
    Number of cases of HPV negative conversion after medication/total cases ×100%
    Time Frame
    1 month and 1 year after drug discontinuation
    Secondary Outcome Measure Information:
    Title
    Vaginal microecological improvement
    Description
    Concentration and diversity of vaginal microflora after drug treatment
    Time Frame
    1 week after drug discontinuation

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cui Yingying, doctorate
    Phone
    15953114125
    Email
    yingyingcui2006@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of HPV Infection in Perimenopausal and Postmenopausal Women

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