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

NCT ID: NCT06516757

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-05
• Study Completion Date: 2024-07-05

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Boric Acid Suppository

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

The Killer®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Love Wellness

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20412

Identifier Type: -

Identifier Source: org_study_id