A Single Group Study to Evaluate the Effects of a pH Balanced Cleanser on Women's Intimate Health.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Love Wellness
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Effect of pH Balanced Cleanser on Vulvar and Vaginal Health
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •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 birth control
- •Recent surgeries or invasive treatments
Arms & Interventions
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.
Intervention: pH Balanced Cleanser (Dietary Supplement)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Tolerability of pH Balanced Cleanser(Baseline, first use, Week 2, Week 4, Week 6, Week 8)