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:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT02452866
Eligibility Criteria:
Inclusion Criteria:
* Are adult females or postmenarchal adolescent girls ≥ 12 years of age.
* Are in good general health as confirmed by a medical history and physical examination, with no known medical or mental health conditions that, in the Investigator's opinion, may interfere with study participation.
* Have a negative urine pregnancy test result prior to study treatment initiation. In addition, female patients of childbearing potential must be using an acceptable form of birth control as determined by the Investigator
* Agree to abstain from alcohol for 3 days following study treatment.
* Have a clinical diagnosis of bacterial vaginosis
* Agree not to use vaginal douches or similar products for the duration of the study.
Exclusion Criteria:
* Are pregnant, lactating, or planning to become pregnant during the study.
* Are menstruating or have vaginal bleeding at the Baseline visit (Day 1).
* Are menopausal as determined by the Investigator
* Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex
* Have active genital lesions, including active Herpes simplex lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator
* Have consumed any alcohol within 12 hours prior to treatment with study medication.
* Have a history of an abnormal Pap smear which required cervical biopsy or cervical cauterization within 3 months of the Baseline visit (Day 1).
* Have any history of cervical carcinoma or other carcinomas of the vagina or vulva.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
12 Years
Study:
NCT02452866
Study Brief:
Protocol Section:
NCT02452866