Vaginal Infection
Conditions
Brief summary
This study will evaluate the efficacy and safety of a vaginal product compared with that of another vaginal product in the treatment of vaginal infections.
Interventions
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, Russia, United States
Outcome results
None listed