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

NCT07109869 | Recruiting Phase 3 FDA Drug

• 1 other identifier: PHD-CLIN-BOR302
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Vulvovaginal Candidiases; Vulvovaginal Candidiasis, Genital; Vulvovaginal Candidiasis (VVC)

Keywords

Vulvovaginal Candidiases; VVC

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with the absence of all signs and symptoms of vulvovaginal candidiasis

  The proportion of patients who achieve clinical cure (defined as the absence of all signs and symptoms of vulvovaginal candidiasis (VVC) \[ie, composite VSS score = 0\] in the absence of additional antifungal treatment), at the test-of-cure (TOC) visit. This is the proportion of patients in the modified ITT (mITT) Population with clinical cure. * Signs: vulvovaginal edema, erythema, excoriation/fissures; * Symptoms: vulvovaginal itching, burning, irritation; and * Severity of each sign and symptom graded on a 0 to 3 rating scale: * Absent = 0; * Mild = 1; * Moderate = 2; or * Severe = 3.

  28 days (+ 2 days)

Secondary Outcomes (11)

• Proportion of patients with clinical cure at the end-of-treatment visit

  15 days (+ 2 days)

• Proportion of patients with clinical cure at the test-of-cure visit

  28 days (+ 2 days)

• Proportion of patients with mycological eradication at the end-of-treatment visit

  14 days (+ 2 days)

• Proportion of patients with mycological eradication at the test-of-cure visit

  28 days (+ 2 days)

• Proportion of patients with overall cure at the end-of-treatment visit

  15 days (+ 2 days)

Study Arms (3)

14 days 600 mg boric acid inserts

EXPERIMENTAL

All patients will self-administer 600 mg boric acid vaginal inserts once daily for 14 days.

Drug: Boric acid

7 days 600 mg boric acid inserts followed by 7 days placebo inserts

EXPERIMENTAL

All patients will self-administer 600 mg boric acid vaginal inserts once daily for first 7 days and placebo vaginal inserts for following 7 days.

Drug: Boric acid; Other: Placebo

14 days placebo inserts

PLACEBO COMPARATOR

All patients will self-administer placebo vaginal inserts once daily for 14 days.

Other: Placebo

Interventions

Boric acid DRUG

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.

Also known as: Orthoboric acid, Hydrogen orthoborate, Trihydroxidoboron

14 days 600 mg boric acid inserts; 7 days 600 mg boric acid inserts followed by 7 days placebo inserts

Placebo OTHER

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

14 days placebo inserts; 7 days 600 mg boric acid inserts followed by 7 days placebo inserts

Eligibility Criteria

• Age: 12 Years+
• Gender Eligibility Details: Patients who are postmenarcheal, nonpregnant biological females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are postmenarcheal, nonpregnant biological females, 12 years of age and older, at Screening;
• Patients with acute symptomatic VVC infection at Screening, defined as meeting all of the following criteria:
• A potassium hydroxide (KOH) wet mount or saline wet mount preparation performed from the inflamed vaginal mucosa or secretions demonstrating yeast forms (hyphae or pseudohyphae) of or budding yeast;
• Vaginal pH ≤4.5; and
• Total Vulvar Signs and Symptoms (VSS) Scale score of ≥4: vulvovaginal signs (edema, erythema, and excoriation/fissures) and symptoms (vulvovaginal burning, itching, and irritation) as rated using the VSS Scale.
• Patients between 21 and 29 years of age must have a cervical cancer screening test (Papanicolaou \[Pap\] smear) performed at Screening or have a documented Pap smear result within 1 year of Screening which must be available for the assessment by the PI or qualified designee at the Screening Visit; and
• Patients 30 years of age and older must have documented cervical cancer screening tests (Pap smear and high-risk human papillomavirus \[HPV\]) performed at Screening or have documented results within 1 year of Screening which must be available for the assessment by the PI or qualified designee at the Screening Visit.
• Patients must be suitable candidates for vaginal treatment, able to insert the study drug, and are comfortable undergoing pelvic exams;
• Patients willing and able to provide written informed consent or assent (for those 12 to 17 years of age);
• Patients willing and able to comply with Protocol requirements, instructions, and Protocol-stated restrictions, as determined by the PI;
• Patients willing and able to give authorization for use of protected health information;
• Copper intrauterine device used continuously and successfully for at least 90 days prior to the first dose of study drug;
• Levonorgestrel-releasing intrauterine system used successfully for at least 90 days prior to the first dose of study drug;
• Progestin implant used successfully for at least 90 days prior to the first dose of study drug;
• Monogamy with a vasectomized male partner (medical assessment of the surgical success of the vasectomy must have occurred at least 6 months prior to the first dose of study drug);

You may not qualify if:

• Patients with known or suspected other active infectious causes of cervicitis, vaginitis, or vulvitis (eg, BV, Chlamydia trachomatis, Neisseria gonorrhoeae, T. vaginalis, or genital lesions consistent with HPV, herpes simplex, syphilis, chancroid, etc) based on the results of clinical assessments, in-clinic microscopic assessments (eg, clue cells or trichomonads detected on saline wet mount), and/or rapid diagnostic tests (RDTs) performed prior to enrollment (eg, OSOM® test, etc);
• Patients who have undergone any vaginal rejuvenation procedure (ie, laser) within 4 weeks prior to Screening or plan to undergo a vaginal rejuvenation procedure prior to completion of the last planned assessment;
• Patients who will undergo evaluation or treatment during the clinical study for abnormal cytology or findings from high-risk HPV testing or Pap test finding;
• Patients diagnosed with BV, determined by meeting 3 of the 4 Amsel's criteria:
• A fishy odor of the vaginal discharge before or after the addition of a drop of 10% KOH (ie, a positive whiff test);
• Homogenous, thin discharge (milk-like consistency) that smoothly coats the vaginal walls;
• At least 20% of epithelial cells are clue cells (eg, vaginal epithelial cells studded with adherent bacteria) on saline wet mount microscopic evaluation of vaginal discharge; or
• pH of vaginal fluid \>4.5.
• Patients currently undergoing treatment for or with a history of treatment for cervical, vaginal, or vulvar cancer;
• Patients using any systemic (eg, oral or injectable) corticosteroid treatment during the study or within 30 days prior to Screening;
• Patients using topical steroids applied to the vulvar or vaginal regions during the study or within 7 days prior to Screening;
• Patients using any systemic (eg, oral or injectable) or topical (applied to the vulvar or vaginal regions) antimicrobials including antifungal, antiviral, antibacterial, or anti-trichomonal drugs during the clinical study or within 14 days prior to Screening;
• Patients using any prescription (eg, vaginal estrogen, ospemifene, prasterone) or non-prescription intravaginal or vulvar product (eg, vitamin E gel capsules \[vaginal inserts\], lubricants, moisturizers, douches, creams, or spermicides) within 7 days prior to Screening and through Day 28 (Visit 5);
• Patients with a current immunocompromising condition (ie, HIV, end-stage renal disease);
• Patients using any immunosuppressive medication (included, but not limited to, carbamazepine, cyclosporine, tacrolimus, methotrexate, 6 mercaptopurine, or mycophenolate) or radiation treatment within 3 months prior to Screening or during the clinical study;

Sponsors & Collaborators

• pH-D Feminine Health LLC: lead

Study Sites (27)

Alliance for Multispecialty Research - Mobile

Mobile, Alabama, 36608, United States

RECRUITING

Abby's Research Institute

Phoenix, Arizona, 85031, United States

WITHDRAWN

Applied Research Center of Arkansas Inc.

Little Rock, Arkansas, 72205, United States

RECRUITING

Century Research Institute, Inc

Huntington Park, California, 90255, United States

RECRUITING

Matrix Clinical Research

Los Angeles, California, 90057, United States

RECRUITING

M3 Wake Research - San Diego

San Diego, California, 92111, United States

RECRUITING

Integrated Clinical Research LLC

Sherman Oaks, California, 91403, United States

RECRUITING

Project 4 Research Inc

Miami, Florida, 33125, United States

RECRUITING

Entrust Clinical Research

Miami, Florida, 33176, United States

RECRUITING

Felicidad Medical Research, LLC

Miami, Florida, 33184, United States

RECRUITING

Better Life Clinical Research, LLC

Tampa, Florida, 33607, United States

RECRUITING

Helping Hands Health Center

Tampa, Florida, 33634, United States

RECRUITING

One Health Research Clinic Inc.

Johns Creek, Georgia, 30097, United States

RECRUITING

Leavitt Clinical Research

Idaho Falls, Idaho, 83404, United States

RECRUITING

Clinical Trials Management, LLC - Northshore

Covington, Louisiana, 70433, United States

RECRUITING

Praetorian Pharmaceutical Research

Marrero, Louisiana, 70072, United States

RECRUITING

Revive Research Institute, Inc.

Dearborn Heights, Michigan, 48126, United States

RECRUITING

Cross Creek Medical Clinic, PA

Fayetteville, North Carolina, 28304, United States

RECRUITING

Unified Women's Clinical Research - Raleigh

Raleigh, North Carolina, 27607, United States

RECRUITING

Unified Women's Clinical Research - Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Complete Health Care for Women

Columbus, Ohio, 43231, United States

RECRUITING

Nexgen Research

Lima, Ohio, 45801, United States

RECRUITING

Chattanooga Medical Research, Chattanooga

Chattanooga, Tennessee, 37412, United States

RECRUITING

Jackson Clinic

Jackson, Tennessee, 38305, United States

RECRUITING

TMC Life Research, Inc

Houston, Texas, 77054, United States

RECRUITING

SMS Clinical Research, LLC

Mesquite, Texas, 75149, United States

RECRUITING

National Clinical Trials - VA

Reston, Virginia, 20190, United States

RECRUITING

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

boric acid

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Officials

• Clinical Trial Manager

  Medpace GmbH

  STUDY CHAIR

Central Study Contacts

Clinical Trial Manager

CONTACT

513-709-4442; s.sammons@medpace.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-02

Locations

US (27)