Safety Assessment of pH-D New Instant Rinse for One Time Use

Safety Assessment of pH-D New Instant Rinse for One Time Use

Demonstrate the safety characteristics of new formulations of pH-D foam wash and instant rinse

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

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