NCT05863975

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2023

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

2.5 years

First QC Date

March 26, 2023

Last Update Submit

May 8, 2023

Conditions

HPV Infection

Keywords

PerimenopausepostmenopausalHPV infectiontreatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Vaginal microecological improvement

    1 week after drug discontinuation

Study Arms (3)

Interferon group

EXPERIMENTAL

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

Promestriene group

EXPERIMENTAL

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

Interferon + promestriene combination group

EXPERIMENTAL

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

Interventions

Human interferon alpha 2b vaginal Effervescent capsulesDRUG

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.

Also known as: Promestriene cream, Human interferon alpha 2b vaginal Effervescent capsules+Proestradiene cream
Interferon + promestriene combination groupInterferon groupPromestriene group

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Cui Yingying, doctorate

CONTACT

15953114125yingyingcui2006@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2023

First Posted

May 18, 2023

Study Start

July 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 18, 2023

Record last verified: 2023-05