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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-09

Study Completion Date

2024-06-03

Brief Summary

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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.

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Detailed Description

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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

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Vaginal Health Vaginal pH

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

pH Balanced Cleanser

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Love Wellness pH Balanced Cleanser

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes