Vaginitis, Vulvovaginitis
Conditions
Brief summary
This study will evaluate the efficacy and safety of a vaginal product compared with that of other vaginal products in the treatment of vaginal infections.
Interventions
semi solid, single dose
semi solid, single dose
semi solid, single dose
Sponsors
Lumara Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have a clinical diagnosis of vaginal infection. * Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.
Exclusion criteria
* Patients must not have any other infections * May not be pregnant or nursing * May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical symptom resolution. | baseline, 7 to 10 days and 21 to 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Yeast Culture for Candida | baseline, 7 to 10 days and 21 to 30 days | Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response |
| Gram stain Nugent score | baseline, 7 to 10 days and 21 to 30 days | Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution |
| Saline wet mount for clue cells | baseline, 7 to 10 days and 21 to 30 days | Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution |
Countries
India, Puerto Rico, Russia, United States
Outcome results
None listed