ClinicalTrials.gg
CompletedNCT06516731Updated Jul 24, 2024

A Single Group Study to Evaluate the Effects of a pH Balanced Cleanser on Women's Intimate Health.

An interventional study of pH Balanced Cleanser in Vaginal Health and Vaginal pH, sponsored by Love Wellness. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by Love Wellness · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Feb 2024, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Vaginal Health
  • Vaginal pH

Keywords

  • pH Balanced Cleanser
  • Vaginal Health
  • Women's Health
  • Intimate Hygiene
  • Intimate Skin Care
03

In context

Lead sponsor

Love Wellness is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • History of vaginal, cervical, vulvar, uterine, or ovarian cancer
  • Recent changes or discontinuation of hormonal
  • Recent surgeries or invasive treatments
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    pH Balanced Cleanser

    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.

    Dietary Supplement: pH Balanced Cleanser

Interventions

  • Dietary supplementpH 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.

    Also known as: Love Wellness pH Balanced Cleanser

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, first use, Week 2, Week 4, Week 6, Week 8

  2. Effect of pH Balanced Cleanser on Vulvar and Vaginal Health

    Vaginal pH testing will be conducted weekly from Baseline to Week 8.

    Time frame: 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.

    Time frame: Baseline, first use, Week 2, Week 4, Week 6, Week 8

07

Study locations

1 site
  • Citruslabs
    Santa Monica, California 90404, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06516731
Lead sponsor
Love Wellness
Collaborators
Citruslabs
Responsible party
Sponsor
First posted
Jul 24, 2024
Start date
Feb 9, 2024
Primary completion
Jun 3, 2024
Completion
Jun 3, 2024
Last update
Jul 24, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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