Treatment of HPV Infection in Perimenopausal and Postmenopausal Women

Therapeutic Effect of Topical Estrogen and Human Interferon Alpha 2b Vaginal Effervescent Capsules in Perimenopausal and Postmenopausal Women With High-risk HPV Infection

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HPV Infection
• Intervention / Treatment: Drug: Human interferon alpha 2b vaginal Effervescent capsules

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cui Yingying, doctorate; Phone Number: 15953114125; Email: yingyingcui2006@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interferon group; 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	Drug: Human interferon alpha 2b vaginal Effervescent capsules; 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.; Other Names: Promestriene cream; Human interferon alpha 2b vaginal Effervescent capsules+Proestradiene cream
Experimental: Promestriene group; promestriene cream vaginal medication, once a day, 1g each time, 10 days, for a course of treatment, a total of 3 courses of treatment	Drug: Human interferon alpha 2b vaginal Effervescent capsules; 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.; Other Names: Promestriene cream; Human interferon alpha 2b vaginal Effervescent capsules+Proestradiene cream
Experimental: Interferon + promestriene combination group; 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.	Drug: Human interferon alpha 2b vaginal Effervescent capsules; 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.; Other Names: Promestriene cream; Human interferon alpha 2b vaginal Effervescent capsules+Proestradiene cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV negative conversion rate	Number of cases of HPV negative conversion after medication/total cases ×100%	1 month and 1 year after drug discontinuation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal microecological improvement	Concentration and diversity of vaginal microflora after drug treatment	1 week after drug discontinuation

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: treatment; postmenopausal; HPV infection; Perimenopause
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Infections; Communicable Diseases; Papillomavirus Infections; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Interferon alpha-2
• Other Study ID Numbers: 49557358-X

Drug and device information, study documents

• 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