Vaginal HealthNCT06516731
A Single Group Study to Evaluate the Effects of a pH Balanced Cleanser on Women's Intimate Health.
A study testing pH Balanced Cleanser in people with Vaginal Health and Vaginal pH, run by Love Wellness at 1 site in United States.
Trial summary
This virtual single-group study will last 8 weeks, involving the daily use of a pH Balanced Cleanser by 40 female participants. The study aims to evaluate the effect of the cleanser on signs of vulvar and vaginal health and its tolerability. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Health, Vaginal pH
- What is being tested?
- pH Balanced Cleanser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2024to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participants aged 18+
- Self-reported issues with vaginal odor, itching, or intimate skin discomfort
- Previous use of vaginal cleansers without severe adverse reactions
- Generally healthy without uncontrolled chronic diseases
- Willing to avoid intra-vaginal products during the study
- Consistent use of any vaginal health-targeted supplements for at least 3 months prior
Who cannot join
- Pre-existing chronic conditions preventing protocol adherence
- Planned reproductive health procedures
- Recent changes in medications or supplements targeting vaginal health
- Known severe allergic reactions
- Pregnancy, breastfeeding, or attempting to conceive
- Unwillingness to follow study protocol
Show all 9Show fewer
- History of vaginal, cervical, vulvar, uterine, or ovarian cancer
- Recent changes or discontinuation of hormonal birth control
- Recent surgeries or invasive treatments
Trial locations and contacts
1 site in 1 country.
About this study
This virtual single-group study will last 8 weeks, involving the daily use of a pH Balanced Cleanser by 40 female participants. The study aims to evaluate the effect of the cleanser on signs of vulvar and vaginal health and its tolerability.
Read the detailed description
Participants will use the Love Wellness pH Balanced Cleanser daily during showers. Questionnaires will be completed at Baseline, first use, Week 2, Week 4, Week 6, and Week 8. Vaginal pH testing will be conducted weekly using Vaginox vaginal pH testing strips. The primary objective is to assess parameters of vulvar and vaginal health, while the secondary objective is to evaluate product tolerability.
- Conditions
- Vaginal Health, Vaginal pH
- Being tested
- pH Balanced Cleanser
- Keywords
- pH Balanced Cleanser, Vaginal Health, Women's Health, Intimate Hygiene, Intimate Skin Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pH Balanced CleanserDietary supplement
Also called Love Wellness pH Balanced Cleanser
Participants will use the pH Balanced Cleanser daily during showers. The cleanser should be applied to the vulva with clean hands, gently worked into a lather, and rinsed clean. Participants will complete baseline and weekly questionnaires and vaginal pH tests over an 8-week period to evaluate the effects on vulvar and vaginal health, including odor and pH levels, and assess the tolerability of the product.
| Study group | Role | What they receive |
|---|---|---|
| pH Balanced Cleanser | Experimental | Participants will use the pH Balanced Cleanser daily during showers. The study will evaluate the effects on vulvar and vaginal health, including odor and pH levels, and assess the tolerability of the product. Receives: Dietary Supplement: pH Balanced Cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of pH Balanced Cleanser on Vulvar and Vaginal Health
Parameters associated with vulvar and vaginal health, including odor and pH levels, will be evaluated. Participants will complete questionnaires at Baseline, first use, Week 2, Week 4, Week 6, and Week 8.
Measured: Baseline, first use, Week 2, Week 4, Week 6, Week 8
Effect of pH Balanced Cleanser on Vulvar and Vaginal Health
Vaginal pH testing will be conducted weekly from Baseline to Week 8.
Measured: Baseline and Week 8
Secondary outcomes (1)
Tolerability of pH Balanced Cleanser
The tolerability of the product will be evaluated via questionnaires at first use, Week 2, Week 4, Week 6, and Week 8. Parameters of interest include reported irritation or itchiness associated with the product, comfort when using the product, negative changes in vaginal pH associated with product use, and participants' overall perceptions of the product.
Measured: Baseline, first use, Week 2, Week 4, Week 6, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start9 Feb 2024
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal HealthStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Love Wellness
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516731
- Sponsor's protocol ID
- 20401
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group Study to Evaluate the Effects of a pH Balanced Cleanser on Women's Intimate Health.
- ClinicalTrials.gov ID
- NCT06516731
- Acronym / sponsor ID
- 20401
- Conditions
- Vaginal Health, Vaginal pH
- Keywords
- pH Balanced Cleanser, Vaginal Health, Women's Health, Intimate Hygiene, Intimate Skin Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Love WellnessIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 24 Jul 2024 (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.
This virtual single-group study will last 8 weeks, involving the daily use of a pH Balanced Cleanser by 40 female participants. The study aims to evaluate the effect of the cleanser on signs of vulvar and vaginal health and its tolerability.
Detailed description
Participants will use the Love Wellness pH Balanced Cleanser daily during showers. Questionnaires will be completed at Baseline, first use, Week 2, Week 4, Week 6, and Week 8. Vaginal pH testing will be conducted weekly using Vaginox vaginal pH testing strips. The primary objective is to assess parameters of vulvar and vaginal health, while the secondary objective is to evaluate product tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pH Balanced Cleanser | Experimental | Dietary Supplement: pH Balanced CleanserParticipants will use the pH Balanced Cleanser daily during showers. The study will evaluate the effects on vulvar and vaginal health, including odor and pH levels, and assess the tolerability of the product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female participants aged 18+
- Self-reported issues with vaginal odor, itching, or intimate skin discomfort
- Previous use of vaginal cleansers without severe adverse reactions
- Generally healthy without uncontrolled chronic diseases
- Willing to avoid intra-vaginal products during the study
Key exclusion criteria (9 listed)
- Pre-existing chronic conditions preventing protocol adherence
- Planned reproductive health procedures
- Recent changes in medications or supplements targeting vaginal health
- Known severe allergic reactions
- Pregnancy, breastfeeding, or attempting to conceive
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 |
|---|---|---|
| pH Balanced CleanserAlso: Love Wellness pH Balanced CleanserParticipants will use the pH Balanced Cleanser daily during showers. The cleanser should be applied to the vulva with clean hands, gently worked into a lather, and rinsed clean. Participants will complete baseline and weekly questionnaires and vaginal pH tests over an 8-week period to evaluate the effects on vulvar and vaginal health, including odor and pH levels, and assess the tolerability of the product. | Dietary supplement | pH Balanced Cleanser |
Primary outcome
Effect of pH Balanced Cleanser on Vulvar and Vaginal Health
Time frame: Baseline, first use, Week 2, Week 4, Week 6, Week 8
Parameters associated with vulvar and vaginal health, including odor and pH levels, will be evaluated. Participants will complete questionnaires at Baseline, first use, Week 2, Week 4, Week 6, and Week 8.
Effect of pH Balanced Cleanser on Vulvar and Vaginal Health
Time frame: Baseline and Week 8
Vaginal pH testing will be conducted weekly from Baseline to Week 8.
1 secondary outcome
Tolerability of pH Balanced Cleanser
Time frame: Baseline, first use, Week 2, Week 4, Week 6, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pH Balanced Cleanser in people with Vaginal Health and Vaginal pH, run by Love Wellness at 1 site in United States.
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 9 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: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of pH Balanced Cleanser on Vulvar and Vaginal Health (time frame: Baseline, first use, Week 2, Week 4, Week 6, Week 8). The study lists 2 primary outcomes in all. 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 24 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.