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

Not Applicable

Completed

• Conditions: Vaginal Health; Bacterial Vaginosis
• Interventions: Dietary Supplement: Boric Acid Suppository

• Registration Number: NCT06516757
• Lead Sponsor: Love Wellness

Brief Summary

This is a virtual single-group clinical trial that will last 12 weeks. Participants will use The Killer® (Boric Acid Suppositories) once daily for 7 consecutive days when they feel that they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. Participants will complete a questionnaire before using the product and on Days 3 and 7 of using the product. They will also complete a vaginal swab pH test before using the product and after 7 days of using the product (Day 8).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-05
• Status Verified: 2024-07
• Primary Completion: 2024-07-05
• Study Completion: 2024-07-05
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Female at birth
• Aged 18+
• Interested in maintaining a calm, soothed, and healthy vaginal environment and balanced vaginal pH levels
• Regularly experience atypical vaginal smell, discharge, itching, swelling, irritation, pain or - burning during sex, and/or a burning sensation while urinating
• Willing to avoid introducing any products or new forms of prescription medication or supplements targeting vaginal health during the study period
• Has used a boric acid suppository before
• Willing to avoid the use of any intra-vaginal products during the study product use
• Willing and able to follow the study protocol

Exclusion Criteria

• Surgeries or invasive treatments in the last six months or planned during the study period
• Introduced any products or forms of prescription medication or supplements targeting vaginal health in the last 12 weeks
• Known allergies to the product ingredients
• Diagnosed with chronic health conditions impacting participation
• Pregnant, breastfeeding, or trying to conceive
• History of substance abuse
• Current or former smoker within the past six months
• Unwilling to follow the study protocol
• Currently participating in any other clinical trial or perception study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Boric Acid Suppository Group	Boric Acid Suppository	Participants will use 600 mg Boric Acid Gelatin Capsules (The Killer®) once daily for 7 consecutive days when they feel they are experiencing any signs of vaginal imbalance such as vaginal malodor, irritation, and/or itching.

Primary Outcome Measures

Name	Time	Method
Vaginal Health and Balance	Baseline, and Day 8	Vaginal pH testing

Secondary Outcome Measures

Name	Time	Method
Participant Perception of Product Convenience	Day 3 and Day 7	Assessment of participant perception of the convenience of the boric acid suppository compared to other boric acid suppositories via questionnaires.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States