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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 12
Healthy Volunteers: f
View:

• 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 preparation performed from the inflamed vaginal mucosa or secretions demonstrating yeast forms (hyphae or pseudohyphae) of 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 aged 21 and older must have cervical cancer screening results meeting the following criteria for inclusion at Screening or within the 1 year prior to Screening: negative for intraepithelial lesion or malignancy or clinically insignificant findings not requiring any further surveillance or treatment beyond a repeat cervical cytology test;

‣ 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 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 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;

• Patients of childbearing potential (as defined in Inclusion Criterion 1) must use 1 of the following contraceptive options described below through Day 28 (Visit 5):

‣ 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);

⁃ Abstinence; or

⁃ Use of 1 of the following hormonal methods in combination with 1 of the following barrier methods:

• Hormonal methods

∙ Barrier methods

• Patients must be willing to avoid tampon or menstrual cup use during the Treatment Period (ie, Day 1 to Day 14); and

⁃ Patients must be willing to abstain from receiving oral intercourse during the Treatment Period (ie, Day 1 to Day 14).

Locations
United States
Alabama
Alliance for Multispecialty Research - Mobile
RECRUITING
Mobile
Arizona
Abby's Research Institute
RECRUITING
Phoenix
California
Century Research Institute, Inc
RECRUITING
Huntington Park
Matrix Clinical Research
RECRUITING
Los Angeles
Florida
Entrust Clinical Research
RECRUITING
Miami
Felicidad Medical Research, LLC
RECRUITING
Miami
Project 4 Research Inc
RECRUITING
Miami
Better Life Clinical Research, LLC
RECRUITING
Tampa
Helping Hands Health Center
RECRUITING
Tampa
Idaho
Leavitt Clinical Research
RECRUITING
Idaho Falls
Louisiana
Clinical Trials Management, LLC - Northshore
RECRUITING
Covington
Praetorian Pharmaceutical Research
RECRUITING
Marrero
Michigan
Revive Research Institute, Inc.
RECRUITING
Dearborn Heights
North Carolina
Cross Creek Medical Clinic, PA
RECRUITING
Fayetteville
Unified Women's Clinical Research - Raleigh
RECRUITING
Raleigh
Unified Women's Clinical Research - Lyndhurst Clinical Research
RECRUITING
Winston-salem
Ohio
Nexgen Research
RECRUITING
Lima
Tennessee
Jackson Clinic
RECRUITING
Jackson
Texas
TMC Life Research, Inc
RECRUITING
Houston
Virginia
National Clinical Trials - VA
RECRUITING
Reston
Contact Information
Primary
Clinical Trial Manager
s.sammons@medpace.com
513-709-4442
Time Frame
Start Date: 2025-08
Estimated Completion Date: 2026-06
Participants
Target number of participants: 201
Treatments
Experimental: 14 days 600 mg boric acid inserts
All patients will self-administer 600 mg boric acid vaginal inserts once daily for 14 days.
Experimental: 7 days 600 mg boric acid inserts followed by 7 days placebo inserts
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.
Placebo_comparator: 14 days placebo inserts
All patients will self-administer placebo vaginal inserts once daily for 14 days.
Sponsors
Leads: pH-D Feminine Health LLC

This content was sourced from clinicaltrials.gov

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