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

Love Wellness

Status: Completed

Conditions: Vaginal pH; Vaginal Health

Treatments: Dietary Supplement: pH Balanced Cleanser

Study type: Interventional

Funder types: Industry

Identifiers

NCT06516731

20401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

pH Balanced Cleanser

Experimental group

Description:

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.

Treatment:

Dietary Supplement: pH Balanced Cleanser