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Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05863975
Study type Interventional
Source Qianfoshan Hospital
Contact Cui Yingying, doctorate
Phone 15953114125
Email yingyingcui2006@163.com
Status Not yet recruiting
Phase Phase 4
Start date July 1, 2023
Completion date December 31, 2025

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