genitourinary syndrome of menopause
Conditions
Interventions
A group:Vaginal lubricant
B group:Promestriene vaginal soft capsules
C group:CO2 laser treatment
D group:Radiofrequency therapy
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
Female
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The age of the subjects is between 40-70 years old (including the boundary value); 2. Have a history of sexual life; 3. In line with the diagnostic criteria of GSM in the "Expert Consensus on Clinical Diagnosis and Treatment of Menopausal Genitourinary Syndrome": asking the medical history and gynecological examination is the main basis for diagnosing GSM; 4. Menopausal women (with or without hysterectomy) must meet one of the following three conditions: 1) Non-hysterectomy, menopause for =12 months; 2) Menopause > 6 months and 40IU/L; 3) Bilateral oophorectomy (with or without hysterectomy) =6 months from baseline assessment (Day 1). 5. During the screening period and baseline (day 1), by vaginal cell smear, the surface cells are =5%, and the vaginal pH value is >5. 6. Normal breast physical examination and negative breast ultrasound results (BI-RADS grade 1, 2 or 3) within 9 months before the baseline visit (Day 1). 7. Normal range of cervical smear results (including inflammatory changes) within 12 months prior to the baseline visit (Day 1). 8. Voluntarily participate in this clinical trial and sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1) Currently suffering from or suspected of malignant tumor. 2) Suffering from active thromboembolic disease or a history of thromboembolic disease (excluding thromboembolic events due to accidents, surgery, and immobilization). 3) Clinically significant acute and chronic diseases (such as diabetes, abnormal liver and kidney function) that have not been controlled by drugs. 4) Those who have used estrogen, pregnancy, and androgenic drugs within 6 months before the baseline visit (day 1). 5) Have received vaginal energy therapy in the past 6) Diagnosed depression that is poorly controlled under standard treatment or a history of confirmed mental illness. 7) Those who have participated in or plan to participate in clinical trials of other drugs or devices within 1 month before the screening visit. 8) Uterine prolapse in stage III and above. 9) Active genital or urinary tract infection. 10) History of previous vaginal patch surgery. 11) History of genital tract, urinary tract or intestinal radiotherapy. 12) Unexplained vaginal bleeding. 13) Suspected pregnancy or lactation. 14) Those who are known to be allergic to the test drug or its ingredients. 15) Those who cannot follow the requirements and steps of the protocol, or any other subjects who are judged by the investigator to be unsuitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS;VSQ; | — |
Secondary
| Measure | Time frame |
|---|---|
| VMI;VHI;FSFI;ICIQ-UI-SF; | — |
Countries
China
Contacts
Public ContactHUYAN
Peking University Shenzhen Hospital
Outcome results
None listed