Genitourinary syndrome of menopause (GSM)
Conditions
Interventions
A:Moisturizer combined with lubricants for vaginal use
B:Vitamin E softgel combined with lubricants for vaginal use
C:Soy isoflavone softgel combined with lubricants for vaginal use
D:Live lactobacillus capsule combined with lubricants for vaginal use
E:Soy isoflavone and Vitamin E softgel combined with lubricants for vaginal use
F:Estrogen cream for vaginal use
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Meet the diagnosis of GSM: 1. Menopause (conforming to any of the following): The age of women >=40 years, and FSH>40U/L, after hysterectomy; The age of women >=40 years, and menopause >=12 months; The age of women >=40 years, menopause >=6 months, and FSH>40U/L; The age of women 40U/L after bilateral ovariectomy; The age of women 40U/L, and menopause >=4-6 months. 2. Women have at least one of the following symptoms. (1) Reproductive tract related symptoms: itching of the vulva or vagina, vaginal dryness, burning pain, repeated abnormal discharge, etc.; (2) Urinary tract related symptoms: frequent urination, urgency, urethral discomfort, increased nocturia, dysuria, repeated urinary tract infections, etc.; (3) Changes in the quality of sexual life: decreased libido, dyspareunia, painful intercourse, etc. 3. Women have signs of urogenital atrophy: Reduced vaginal elasticity, disappearance of wrinkles, pale mucous membranes, and reduced lubrication.
Exclusion criteria
Exclusion criteria: 1. Acute inflammation of the reproductive tract; 2. Using hormone drugs in the past 2 months; 3. Using antibiotics or receiving GSM treatment in the past few months; 4. There are organic lesions such as skin lesions of the vulva, vaginal and cervical intraepithelial neoplasia, urinary tract tumors and stones; 5. Those who have contraindications or allergies to the drugs and preparations used in the research of this subject; 6. Suffering from mental system diseases and organic encephalopathy; 7. Combined with chronic diseases affecting treatment compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The scoring of GSM symptom;The Female Sexual Function Index (FSFI) was used to assess the sexual function status of women in each group before and after treatment.;The Female Sexual Distress Scale-revised (FSDS-R) was used to evaluate the sexual satisfaction of women in each group before and after treatment.;The Menopause Quality of Life Questionnaire (MENQOL) was used to evaluate the quality of life of women in each group before and after treatment.;Evaluation of satisfaction with symptom relief.;The overall relief of the patient's symptoms;Vaginal Mucosal Scoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal pH;Patient compliance; | — |
Countries
China
Contacts
Public ContactLi Ling
Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed