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

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).

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginosis; Vaginal Health
• Intervention / Treatment: Dietary supplement: Boric Acid Suppository

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Boric Acid Suppository Group; 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.	Dietary supplement: Boric Acid Suppository; Participants will complete a baseline questionnaire and a vaginal pH test before using the product, and additional questionnaires and a pH test after 3 and 7 days of product use.; Other Names: The Killer®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal Health and Balance	Evaluation of vaginal health and balance via participant questionnaires.	Baseline, Day 3, Day 7, and Day 8
Vaginal Health and Balance	Vaginal pH testing	Baseline, and Day 8

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Love Wellness
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2024
• Primary Completion (Actual): July 5, 2024
• Study Completion (Actual): July 5, 2024

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Women's Health; Vaginal Flora; Vaginal pH Balance
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginal Diseases; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginosis, Bacterial
• Other Study ID Numbers: 20412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No