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OpenTrials
Completed

NCT Number: NCT06516757

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: The Killer®

Primary outcomes

  1. Vaginal Health and Balance

    Time frame: Baseline, Day 3, Day 7, and Day 8

    Evaluation of vaginal health and balance via participant questionnaires.

  2. Vaginal Health and Balance

    Time frame: Baseline, and Day 8

    Vaginal pH testing

Secondary outcomes

  1. Participant Perception of Product Convenience

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Love Wellness

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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