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Clinical Trials/NCT06565312
NCT06565312CompletedNot Applicable

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

Love Wellness2 sites in 1 country40 target enrollmentStarted: May 10, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
Effect on Vaginal pH and Health
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts 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.

Outcomes

Primary Outcomes

Effect on Vaginal pH and Health

Time Frame: Baseline, 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 Outcomes

  • Participant Perception of Vaginal Freshness and Odor(Baseline, Day 2, Day 5)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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