HPV InfectionPhase 4NCT05863975
Treatment of HPV Infection in Perimenopausal and Postmenopausal Women
A Phase 4 study testing Human interferon alpha 2b vaginal Effervescent capsules in people with HPV Infection, run by Qianfoshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- HPV Infection
- What is being tested?
- Human interferon alpha 2b vaginal Effervescent capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- HPV Infection
- Being tested
- Human interferon alpha 2b vaginal Effervescent capsules
- Keywords
- Perimenopause, postmenopausal, HPV infection, treatment
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human interferon alpha 2b vaginal Effervescent capsulesDrug
Also called Promestriene cream, Human interferon alpha 2b vaginal Effervescent capsules+Proestradiene cream
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Drug: Human interferon alpha 2b vaginal Effervescent capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV negative conversion rate
Number of cases of HPV negative conversion after medication/total cases ×100%
Measured: 1 month and 1 year after drug discontinuation
Secondary outcomes (1)
Vaginal microecological improvement
Concentration and diversity of vaginal microflora after drug treatment
Measured: 1 week after drug discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863975
- Sponsor's protocol ID
- 49557358-X
- Status last verified
- May 2023
- First submitted
- 26 Mar 2023
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05863975
- Acronym / sponsor ID
- 49557358-X
- Conditions
- HPV Infection
- Keywords
- Perimenopause, postmenopausal, HPV infection, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interferon group | Experimental | Drug: Human interferon alpha 2b vaginal Effervescent capsulesVaginal 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 group | Experimental | Drug: Human interferon alpha 2b vaginal Effervescent capsulespromestriene cream vaginal medication, once a day, 1g each time, 10 days, for a course of treatment, a total of 3 courses of treatment |
| Interferon + promestriene combination group | Experimental | Drug: Human interferon alpha 2b vaginal Effervescent capsulesgiven 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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The age of 45-65 years (inclusive);
- ⑦ Volunteer to participate in clinical studies and sign informed consent.
Key exclusion criteria (6 listed)
- Allergic to human interferon alpha 2b vaginal effervescent capsules or prolestrene cream;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human interferon alpha 2b vaginal Effervescent capsulesAlso: Promestriene cream, Human interferon alpha 2b vaginal Effervescent capsules+Proestradiene cream①Interferon 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. | Drug | Interferon + promestriene combination group, Interferon group, Promestriene group |
Primary outcome
HPV negative conversion rate
Time frame: 1 month and 1 year after drug discontinuation
Number of cases of HPV negative conversion after medication/total cases ×100%
1 secondary outcome
Vaginal microecological improvement
Time frame: 1 week after drug discontinuation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human interferon alpha 2b vaginal Effervescent capsules in people with HPV Infection, run by Qianfoshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cui Yingying, doctorate (15953114125, yingyingcui2006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV negative conversion rate (time frame: 1 month and 1 year after drug discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.