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

NCT07802483 | Not Yet Recruiting

• 1 other identifier: V-1-2026
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Vaginal Odor

Keywords

vaginal odor; foam wash; vaginal rinse

Outcome Measures

Primary Outcomes (1)

• Written questionnaire to assess outcomes of the single use vaginal odor rinse

  72 hours

Study Arms (3)

subjects using instant rinse (lactic acid)

ACTIVE COMPARATOR

Other: Lactic Acid instant odor rinse

subjects using boric acid

ACTIVE COMPARATOR

Other: Boric Acid instant odor rinse

subjects using placebo

ACTIVE COMPARATOR

Other: Placebo

Interventions

Boric Acid instant odor rinse OTHER

Boric acid one time use instant odor rinse

subjects using boric acid

Lactic Acid instant odor rinse OTHER

Lactic Acid instant odor rinse

subjects using instant rinse (lactic acid)

Placebo OTHER

base solution rinse

subjects using placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-pregnant females, 18 years and older
• Complaint of abnormal vaginal odor with or without complaints of discharge
• Odor rated ≥4 on a 0-10 numerical rating scale (NRS) (0 = NO odor, 10 = strong unpleasant odor)
• Willing/able to comply with study requirements
• Has provided informed consent
• Subject has regular cycle length of 24-35 days

You may not qualify if:

• 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.
• 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.
• Subjects with lower genital tract infections (e.g. symptomatic VVC, trichomoniasis, HSV) diagnosed in the past 30 days
• Subjects with other Vaginal or Vulvar condition that would interfere with clinical interpretation of data (e.g. vaginal or vulvar dysplasia, lichen sclerosis)
• Subject has received antibiotic or antifungal treatment in the past 14 days
• 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
• Investigator considers a medical or other identifiable reason for subject's vaginal odor

Sponsors & Collaborators

• pH-D Feminine Health LLC: lead

Central Study Contacts

Mark Martens, M.D.

CONTACT

918-607-4909; markgmartens@gmail.com

William Faulkner, MBA

CONTACT

6513436370; bfaulkner@talmont-holdings.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share