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A Single Group Study to Evaluate the Effects of a Probiotic Vaginal Suppository on Vaginal Health.

A Single Group Study to Evaluate the Effects of a Probiotic Vaginal Suppository on Vaginal Health.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06565312
Enrollment
40
Registered
2024-08-21
Start date
2024-05-10
Completion date
2024-07-10
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Health, Vaginal pH

Keywords

Vaginal suppository, Women's Health

Brief summary

This is a virtual single-group clinical trial lasting 8 weeks to evaluate the effects of a probiotic vaginal suppository on vaginal health. Participants will use the Flora Power suppository daily for 5 consecutive days when experiencing common signs of vaginal imbalance. They will complete questionnaires and vaginal pH tests before and after product use.

Interventions

DIETARY_SUPPLEMENTFlora Power Probiotic Vaginal Suppository

The suppository contains Microcrystalline Cellulose, Ascorbic Acid, Vitamin C, Gelatin Capsule, Vaginal Probiotic Blend (Lactobacillus fermentum LF61, Lactobacillus acidophilus LA85, Lactobacillus plantarum Lp90), Magnesium Stearate, and Silicon Dioxide.

Sponsors

Citruslabs
CollaboratorINDUSTRY
Love Wellness
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Female at birth, aged 18+. * Interested in maintaining a healthy vaginal environment. * Experience common signs of vaginal imbalance (e.g., malodor, irritation). * Willing to avoid other vaginal products and follow study protocol.

Exclusion criteria

* Recent surgeries or invasive treatments. * Use of vaginal health products in the last 12 weeks. * Allergies to product ingredients. * Chronic health conditions impacting participation. * Pregnant, breastfeeding, or trying to conceive. * History of substance abuse or smoking. * Currently participating in another clinical trial.

Design outcomes

Primary

MeasureTime frameDescription
Effect on Vaginal pH and HealthBaseline, Day 6 (24 hours after the last suppository insertion)Measure the change in vaginal pH levels with a test strip from baseline to 24 hours after the 5-day intervention period.

Secondary

MeasureTime frameDescription
Participant Perception of Vaginal Freshness and OdorBaseline, Day 2, Day 5Evaluate participants' perceptions of the vaginal suppository's impact on vaginal freshness and odor, as well as the support of a calm, soothed, and balanced vaginal environment. This outcome measure is assessed with questionnaires.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026