bacterial vaginosis (BV)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18 years old - women with a history of sexual life before menopause; 2. Asymptomatic BV patients; 3. Vaginal examination: pH > 4.5, Nugent score >= 7 points, white blood cell count: <10/hp; 4. No history of systemic antibiotic use in the past one week; 5. No history of sex life in the past three days, no bath, vaginal irrigation and drug administration; 6. Negative urine pregnancy test; 7. Subjects are willing to have no pregnancy plan from screening to treatment with the study drug and within 3 months after discontinuation and agree to take effective contraception (no sex or barrier contraception throughout the use of condoms).
Exclusion criteria
Exclusion criteria: 1.Pregnant and lactating women; 2.Vaginal secretion white blood cell count: >=10/hp; 3.Other vaginal or vulvar diseases; 4.History of diabetes, cardiovascular and cerebrovascular diseases, liver and kidney diseases, and hematopoietic system (ask about previous medical history); 5.Approaching the menstrual period: It is speculated that the date of the last menstrual period is speculated, and it is within 10 days from the next menstrual period. 6.There is a history of gel allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nugent score;pH;White blood cell count; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal discharge traits;Vaginal discharge odor;Vulvar redness and swelling;Vulvar pain;Itching;Painful urination; | — |
Countries
China