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

NCT06516757 | Completed

• 1 other identifier: 20412
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Vaginal Health; Bacterial Vaginosis

Keywords

Vaginal pH Balance; Vaginal Flora; Women's Health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Participant Perception of Product Convenience

  Day 3 and Day 7

Study Arms (1)

Boric Acid Suppository Group

EXPERIMENTAL

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

Interventions

Boric Acid Suppository DIETARY_SUPPLEMENT

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.

Also known as: The Killer®

Boric Acid Suppository Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Love Wellness: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 24, 2024
• Study Start: April 5, 2024
• Primary Completion: July 5, 2024
• Study Completion: July 5, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)