Postmenopausal atrophic vaginitis
Conditions
Interventions
Experimental group A:Live quadruple Lactobacillus capsules for vaginal use
Placebo group A:Live quadruple Lactobacillus capsules simulant for vaginal use
Experimental group B:Live quadruple Lactobacillus capsules for vaginal use
Placebo group B:Live quadruple Lactobacillus capsules simulant for vaginal use
Sponsors
West China Second University Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily participate in the trial, and sign the informed consent form before the trial begins; 2. Healthy women of reproductive aged 18-45 years (including the critical value); 3. Body mass index (BMI)=weight (kg)/height^2 (m^2), the BMI is in the range of 18.0~30.0 (including the critical value), and the subject's weight is not less than 45.0 kg; 4. Have a sexual life history, be willing to use vaginal medication, and agree to avoid the use of other intravaginal products (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) throughout the trial period; 5. Subjects agree not to use antimicrobial drugs and microbial drugs without permission during the trial; 6. The subjects are willing to take effective contraceptive measures during the trial (avoid sex or use condoms for barrier contraception); 7. The subjects have no reproductive plan within 3 months after the end of the trial, and agree to take effective contraceptive measures voluntarily by themselves and their partners during this period; 8. The subjects can communicate well with the researcher, and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to any of the ingredients in this product and its excipients; or those with allergic constitution (such as those who are allergic to two or more drugs and foods); 2. There are diseases or factors that need to be excluded with abnormal clinical manifestations, including but not limited to diseases of the nervous system, cardiovascular system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bone and other system diseases; there are factors that will endanger the safety of the subjects; or other factors that may affect the drug, such as genital deformities; 3. Subjects with a history of genital herpes infection, a history of more than 2 vaginal infections within 6 months before administration, or urogenital infections within 21 days before administration (including but not limited to urinary tract infection, bacterial vaginosis, Trichomonas vaginalis infection) ); 4. Those who have undergone surgical vaginal operation within 3 months before administration, pelvic or cervix-related surgical treatment or gynecological examination results show obvious vaginal wall injury; 5. Those who have undergone major surgery within 30 days before administration, or plan to undergo surgery during the trial; 6. Those who have a history of drug abuse or have used any drugs within 6 months before administration; 7. Those who donate blood or lose a large amount of blood (>=400ml) within 3 months before administration, receive blood transfusion or use blood products; or those who plan to donate blood or blood components during the trial; 8. Pregnant and lactating subjects; 9. The subject has sex without taking effective and proper contraceptive measures within 30 days before administration; 10. The subject has an egg donation plan from the first medication to 3 months after the end of the study; 11. Use of any prescription or non-prescription drugs within 14 days before administration; 12. Those who have received any vaccine within 7 days before administration; 13. Those who smoked more than 5 cigarettes or used a considerable amount of tobacco products per day on average within 30 days before administration; or those who could not guarantee to stop smoking from the time of signing the informed consent form to the end of the study; 14. Average daily alcohol intake in the 30 days prior to administration of more than 2 units (1 unit = 360ml of beer with 5% alcohol content, or 45ml of spirits with 40% alcohol content, or 150ml of wine with 12% alcohol content ); or those who cannot guarantee to stop drinking and alcoholic products from the time of signing the informed consent form to the end of the study; 15. Long-term drinking of excessive tea, coffee and/or caffeinated beverages within 30 days before administration (more than 8 cups a day, 1 cup = 250ml), or who do not agree to stop drinking tea, coffee and/or caffeinated beverages during the trial; 16. Those who have special requirements for diet and cannot comply with the unified diet or have significantly abnormal/special diets (such as dieting, low-sodium diet) within 30 days before screening; 17. Those who have participated in other drug clinical trials or device clinical trials within 3 months before administration, and have used experimental drugs or experimental devices; 18. Abnormal vital signs, physical examination or gynecological examination with clinical significance; 19. Any abnormality in laboratory examination (including vaginal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;Physical examination;Gynecological examination;Laboratory examination;12 lead ECG;Adverse events;Liquid based thin-layer cytology; | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection of the vaginal microbiota; | — |
Countries
China
Contacts
Public ContactYu Qin
West China Second University Hospital of Sichuan University
Outcome results
None listed