postmenopausal atrophic vaginitis
Conditions
Interventions
Experimental group:Lactobacillus quad live capsule in vaginal use
Control group:placebo
Sponsors
Beijing Tsinghua Chang Gung Hospital
Eligibility
Sex/Gender
Female
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent voluntarily, and be able to follow the requirements of the program procedures; 2. Women with a sexual history, aged =45 years and =70 years at the time of informed consent; 3. At the time of screening, the chief complaint was natural menopause =12 months or medical records showed bilateral ovariectomy =6 months, or follicle-stimulating hormone (FSH) =40 IU/L and estradiol (E2) =20 pg/mL. 4. Moderate to severe vaginal dryness, or moderate to severe dyspareunia for sexually active persons (stable partners and having or attempting to have vaginal intercourse =1 times per month) within 3 months before screening; Note: Vaginal dryness: moderate, most of the time feel vaginal dryness and discomfort, but does not affect daily life; Severe, has been feeling vaginal dryness discomfort, affecting daily life. Pain during intercourse: moderate, most of the time there is pain during intercourse, intercourse brings little satisfaction, often need to stop intercourse; Severe, persistent pain during intercourse, inability to enjoy intercourse, occasional bleeding after intercourse, may abstain from sex due to pain during intercourse. 5. During screening, the vaginal microecological examination should meet the following three criteria: positive cue cells, Nugent score =7, and Donders score =4; 6. Upon signing the informed consent, agree not to perform vaginal douching, use vaginal lubricating moisturizers, or use other similar agents or devices.
Exclusion criteria
Exclusion criteria: 1.During screening, candida vulvovaginosis (VVC) or trichomoniasis vaginitis (TV) and other genital tract infections were combined; 2.Received systematic or vaginal use of antimicrobials, sex hormones or microecologics within 2 weeks prior to screening; 3.Have received vulvar, vaginal, cervical or pelvic surgery or surgical procedures within 10 weeks prior to screening; 4.At the time of screening, the presence of unexplained abnormal vaginal bleeding or gynecological diseases of obvious clinical significance, including but not limited to vulvar dystrophy, vulvar eczema, cervical atypical squamous cells -- not excluded are high-grade squamous intraepithelial lesions (ASC-H), uterine prodrosis (grade 2 or above), endometrial hyperplasia or ovarian tumors; 5.Malignant neoplasms within 5 years prior to screening [other than: a. cervical carcinoma in situ after conical excision; b. Basal cell carcinoma of the skin, squamous cell carcinoma, and/or carcinoma in situ (Bowen's disease) undergoing radical surgery]; 6.When screening, Serum anti-human immunodeficiency virus (anti-HIV) positive, hepatitis B virus surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) =1000 IU/mL, anti-hepatitis C virus antibody (anti-HCV) positive and hepatitis C virus RNA (HCV) positive RNA) positive, or anti-treponema pallidum (anti-Tp) positive; 7.During screening, hemoglobin (Hb) 11×10^9/L, or platelet (PLT) 2 times the upper limit of normal (ULN), total bilirubin (TBIL) > 1.5×ULN, or serum creatinine (SCr) > 1.2×ULN; 9.During screening, it is judged by the researcher that the subjects have clinically major diseases (including cardiovascular, respiratory, digestive, endocrine and metabolic, neuropsychiatric, blood and immune system diseases, etc.) that are poorly controlled. For example, systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg, fasting blood glucose =13.9 mmol/L on different days, or NYHA grade ? or ? cardiac function; 10.During screening, according to the researchers' judgment, the subjects were expected to receive elective surgery within 3 months; 11.A history of drug abuse (social, psychological and physical impairment due to excessive, erroneous or addictive drug use for any non-medical reason) or alcohol abuse [that is, drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40 per cent alcohol or 150 mL wine) in the five years prior to screening]; 12.A history of severe allergic reactions (rapid, life-threatening systemic allergic reactions) to drugs or other components of drugs, such as lactose or gelatin; 13.Participated in other interventional clinical trials, including drugs, vaccines or devices, other than observational trials of marketed drugs, within the 3 months prior to screening; 14. The investigator determined that subjects had other conditions that interfered with the safety and efficacy of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vaginal microecology; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCT (lateral vaginal wall);subjective symptoms;Vaginal sign score; | — |
Countries
China
Contacts
Public ContactLiao Qinping
Beijing Tsinghua Chang Gung Hospital
Outcome results
None listed