Vaginal Odor
Conditions
Keywords
vaginal odor, foam wash, vaginal rinse
Brief summary
Demonstrate the safety characteristics of new formulations of pH-D foam wash and instant rinse
Interventions
OTHERLactic Acid instant odor rinse
Lactic Acid instant odor rinse
OTHERBoric Acid instant odor rinse
Boric acid one time use instant odor rinse
OTHERPlacebo
base solution rinse
Sponsors
pH-D Feminine Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Non-pregnant females, 18 years and older 2. Complaint of abnormal vaginal odor with or without complaints of discharge 3. Odor rated ≥4 on a 0-10 numerical rating scale (NRS) (0 = NO odor, 10 = strong unpleasant odor) 4. Willing/able to comply with study requirements 5. Has provided informed consent 6. Subject has regular cycle length of 24-35 days
Exclusion criteria
1. Patients genital lesions or ulcers consistent with human papillomavirus (HPV), Herpes simplex, syphilis, chancroid, etc.). Patients with a history of genital herpes or condylomata who have been asymptomatic for at least 3 months may be considered for eligibility. 2. Patients who will undergo evaluation or treatment during the study for abnormal cytology and/or findings from high risk HPV testing and/or Pap test finding. 3. Subjects with lower genital tract infections (e.g. symptomatic VVC, trichomoniasis, HSV) diagnosed in the past 30 days 4. Subjects with other Vaginal or Vulvar condition that would interfere with clinical interpretation of data (e.g. vaginal or vulvar dysplasia, lichen sclerosis) 5. Subject has received antibiotic or antifungal treatment in the past 14 days 6. Subject is currently menstruating or is expected to menstruate in the next 7 days. Patients will be enrolled but start suppositories after menses has concluded 7. Investigator considers a medical or other identifiable reason for subject's vaginal odor \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Written questionnaire to assess outcomes of the single use vaginal odor rinse | 72 hours |
Contacts
CONTACTMark Martens, M.D.
CONTACTWilliam Faulkner, MBA
Outcome results
None listed