Vaginal OdorNCT07802483
Safety Assessment of pH-D New Instant Rinse for One Time Use
A study testing Lactic Acid instant odor rinse and Boric Acid instant odor rinse in people with Vaginal Odor, run by pH-D Feminine Health LLC.
Trial summary
Demonstrate the safety characteristics of new formulations of pH-D foam wash and instant rinse Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Odor
- What is being tested?
- Lactic Acid instant odor rinse and Boric Acid instant odor rinse
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Demonstrate the safety characteristics of new formulations of pH-D foam wash and instant rinse
- Conditions
- Vaginal Odor
- Being tested
- Lactic Acid instant odor rinse, Boric Acid instant odor rinse, Placebo
- Keywords
- vaginal odor, foam wash, vaginal rinse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactic Acid instant odor rinseOther
Lactic Acid instant odor rinse
Boric Acid instant odor rinseOther
Boric acid one time use instant odor rinse
PlaceboOther
base solution rinse
| Study group | Role | What they receive |
|---|---|---|
| subjects using instant rinse (lactic acid) | Active comparator | Not described Receives: Other: Lactic Acid instant odor rinse |
| subjects using boric acid | Active comparator | Not described Receives: Other: Boric Acid instant odor rinse |
| subjects using placebo | Active comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Written questionnaire to assess outcomes of the single use vaginal odor rinse
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal OdorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- pH-D Feminine Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802483
- Sponsor's protocol ID
- V-1-2026
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it is private data and there is no intention to share specific results external to the company.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment of pH-D New Instant Rinse for One Time Use
- ClinicalTrials.gov ID
- NCT07802483
- Acronym / sponsor ID
- V-1-2026
- Conditions
- Vaginal Odor
- Keywords
- vaginal odor, foam wash, vaginal rinse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- pH-D Feminine Health LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate the safety characteristics of new formulations of pH-D foam wash and instant rinse
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactic Acid instant odor rinseLactic Acid instant odor rinse | Other | subjects using instant rinse (lactic acid) |
| Boric Acid instant odor rinseBoric acid one time use instant odor rinse | Other | subjects using boric acid |
| Placebobase solution rinse | Other | subjects using placebo |
Primary outcome
Written questionnaire to assess outcomes of the single use vaginal odor rinse
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No. it is private data and there is no intention to share specific results external to the company.
Related trials for Vaginal Odor
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Lactic Acid instant odor rinse and Boric Acid instant odor rinse in people with Vaginal Odor, run by pH-D Feminine Health LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Martens, M.D. (918-607-4909, markgmartens@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Written questionnaire to assess outcomes of the single use vaginal odor rinse (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.