Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT01153958
Eligibility Criteria:
Inclusion Criteria:
* Female subjects in reproductive age and older than 18 year
* Subjects with normal sexual activity
* Subjects with symptoms such as vulva-vaginal irritation or abnormal vaginal discharge
* Subjects with Nugent Score greater than or equal to 7
* Subjects who are willing to use contraception
* Subjects who are willing to refrain from the use of other vaginal products throughout the study
* Subjects who sign informed consent form and agree to follow-up on time
Exclusion Criteria:
* Subjects without sexual activity
* Pregnant or lactating female subjects
* Subjects with a history of recurrent bacterial vaginosis
* Subjects diagnosed with trichomonas vaginitis，vulvovaginal candidiasis，chlamydia or gonococcus infection.
* Subjects who are unwilling to refrain from the ingestion of any alcoholic beverages during the 7 day course of oral metronidazole therapy
* Subjects who are under treatment by lithium, phenobarbitone, coumadine anticoagulant, cyclosporine or disulfiram by the time of inclusion (interactions with other products and metronidazole)
* Subjects who are undergoing systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolic agents by the time of inclusion
* Female subjects with a history of peripheral neuropathy
* Female subjects who have participated in another clinical trial or have taken an experimental drug within the past 30 days
* Subjects who are unable to give written informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01153958
Study Brief:
Protocol Section:
NCT01153958