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

PHASE3RecruitingINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Vulvovaginal CandidiasesVulvovaginal Candidiasis, GenitalVulvovaginal Candidiasis (VVC)
Interventions
DRUG

Boric 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.

OTHER

Placebo

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

Trial Locations (20)

20190

RECRUITING

National Clinical Trials - VA, Reston

27103

RECRUITING

Unified Women's Clinical Research - Lyndhurst Clinical Research, Winston-Salem

27607

RECRUITING

Unified Women's Clinical Research - Raleigh, Raleigh

28304

RECRUITING

Cross Creek Medical Clinic, PA, Fayetteville

33125

RECRUITING

Project 4 Research Inc, Miami

33176

RECRUITING

Entrust Clinical Research, Miami

33184

RECRUITING

Felicidad Medical Research, LLC, Miami

33607

RECRUITING

Better Life Clinical Research, LLC, Tampa

33634

RECRUITING

Helping Hands Health Center, Tampa

36608

RECRUITING

Alliance for Multispecialty Research - Mobile, Mobile

38305

RECRUITING

Jackson Clinic, Jackson

45801

RECRUITING

Nexgen Research, Lima

48126

RECRUITING

Revive Research Institute, Inc., Dearborn Heights

70072

RECRUITING

Praetorian Pharmaceutical Research, Marrero

70433

RECRUITING

Clinical Trials Management, LLC - Northshore, Covington

77054

RECRUITING

TMC Life Research, Inc, Houston

83404

RECRUITING

Leavitt Clinical Research, Idaho Falls

85031

RECRUITING

Abby's Research Institute, Phoenix

90057

RECRUITING

Matrix Clinical Research, Los Angeles

90255

RECRUITING

Century Research Institute, Inc, Huntington Park

All Listed Sponsors
lead

pH-D Feminine Health LLC

INDUSTRY

NCT07109869 - Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis | Biotech Hunter | Biotech Hunter