RecruitingPhase 3NCT07109869

Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis

Safety and Efficacy Study to Assess 600 mg Boric Acid Vaginal Inserts With 7- or 14-Days Treatment of Vulvovaginal Candidiasis (VVC)


Sponsor

pH-D Feminine Health LLC

Enrollment

400 participants

Start Date

Aug 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 3 clinical study to evaluate the efficacy, safety, and tolerability of boric acid 600 mg vaginal inserts in patients with VVC.


Eligibility

Sex: FEMALEMin Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Boric acid and Placebo for people with vulvovaginal candidiases, vulvovaginal candidiasis (vvc), and other related conditions. The study is currently recruiting participants at 27 locations. People eligible for this study include women aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBoric acid

Boric acid vaginal inserts consisting of 600 mg boric acid drug substance filled into white, opaque hypromellose capsules with no additional excipients included in the formulation. Each vaginal insert is sealed into a clear blister cavity.

OTHERPlacebo

Placebo vaginal inserts containing anhydrous lactose and 1% magnesium stearate are also manufactured and filled into white, opaque hypromellose capsules. Packaged in clear blisters.


Locations(27)

Alliance for Multispecialty Research - Mobile

Mobile, Alabama, United States

Abby's Research Institute

Phoenix, Arizona, United States

Applied Research Center of Arkansas Inc.

Little Rock, Arkansas, United States

Century Research Institute, Inc

Huntington Park, California, United States

Matrix Clinical Research

Los Angeles, California, United States

M3 Wake Research - San Diego

San Diego, California, United States

Integrated Clinical Research LLC

Sherman Oaks, California, United States

Project 4 Research Inc

Miami, Florida, United States

Entrust Clinical Research

Miami, Florida, United States

Felicidad Medical Research, LLC

Miami, Florida, United States

Better Life Clinical Research, LLC

Tampa, Florida, United States

Helping Hands Health Center

Tampa, Florida, United States

One Health Research Clinic Inc.

Johns Creek, Georgia, United States

Leavitt Clinical Research

Idaho Falls, Idaho, United States

Clinical Trials Management, LLC - Northshore

Covington, Louisiana, United States

Praetorian Pharmaceutical Research

Marrero, Louisiana, United States

Revive Research Institute, Inc.

Dearborn Heights, Michigan, United States

Cross Creek Medical Clinic, PA

Fayetteville, North Carolina, United States

Unified Women's Clinical Research - Raleigh

Raleigh, North Carolina, United States

Unified Women's Clinical Research - Lyndhurst Clinical Research

Winston-Salem, North Carolina, United States

Complete Health Care for Women

Columbus, Ohio, United States

Nexgen Research

Lima, Ohio, United States

Chattanooga Medical Research, Chattanooga

Chattanooga, Tennessee, United States

Jackson Clinic

Jackson, Tennessee, United States

TMC Life Research, Inc

Houston, Texas, United States

SMS Clinical Research, LLC

Mesquite, Texas, United States

National Clinical Trials - VA

Reston, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07109869


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