Actively Recruiting
Safety and Efficacy Study to Assess 600 mg Boric Acid Vaginal Inserts With 7- or 14-Days Treatment of Vulvovaginal Candidiasis
Led by pH-D Feminine Health LLC · Updated on 2026-06-03
400
Participants Needed
27
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of 600 mg boric acid vaginal inserts for treating vulvovaginal candidiasis (VVC). This Phase 3 clinical trial involves female patients who have acute symptomatic VVC and aims to compare two different dosing durations of boric acid inserts to a placebo. The study is designed as a randomized, placebo-controlled, double-blinded trial to provide clear information on treatment outcomes. Participants will self-administer vaginal inserts once daily for 14 days. There are three groups: one receiving boric acid inserts for the full 14 days, another receiving boric acid inserts for 7 days followed by placebo inserts for 7 days, and a third group receiving placebo inserts for 14 days. During treatment, patients will use an electronic diary to record symptoms, study drug use, sexual activity, menstrual bleeding, and other relevant information. The study includes 4 in-person visits and one phone follow-up over a total participation period of 28 days. Throughout the study, clinical, mycological, and overall outcomes will be assessed at Days 15 and 28. If symptoms persist, additional microbiologic tests will be performed. Participants will undergo evaluations including pelvic exams and laboratory tests, and may receive rescue treatment if necessary. The research team will monitor for the absence of VVC signs and symptoms as the primary outcome, alongside several secondary measures of clinical and mycological cure. Safety and adherence will be closely followed during this 28-day study period.
CONDITIONS
Brief Title
Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who are postmenarcheal, nonpregnant biological females aged 12 years and older at screening
- Acute symptomatic vulvovaginal candidiasis confirmed by yeast presence on wet mount, vaginal pH ≤4.5, and vulvar signs and symptoms score ≥4
- Patients aged 21 and older must have recent cervical cancer screening results within the past year meeting specified criteria
- Suitable candidates for vaginal treatment and comfortable with pelvic exams
- Able and willing to provide informed consent or assent (for ages 12 to 17)
- Able to comply with study requirements and protocol restrictions
- Willing to authorize use of protected health information
- Patients of childbearing potential must use approved contraceptive methods through Day 28
- Willing to avoid tampon or menstrual cup use during the 14-day treatment period
- Willing to abstain from oral intercourse during the 14-day treatment period
You will not qualify if you...
- Presence of other active infectious causes of cervicitis, vaginitis, or vulvitis excluding VVC
- Vaginal rejuvenation procedures within 4 weeks prior to screening or planned before study completion
- Planned evaluation or treatment for abnormal cervical cytology or high-risk HPV during the study
- Diagnosis of bacterial vaginosis based on Amsel's criteria
- History or current treatment for cervical, vaginal, or vulvar cancer
- Use of systemic corticosteroids within 30 days prior to screening or during the study
- Use of topical steroids on vulvar or vaginal areas within 7 days prior to screening or during the study
- Use of systemic or topical antimicrobials including antifungals within 14 days prior to screening or during the study
- Use of intravaginal or vulvar prescription or non-prescription products within 7 days prior to screening or through Day 28
- Unwillingness to refrain from intravaginal product use during the treatment period
- Current immunocompromising conditions such as HIV or end-stage renal disease
- Use of immunosuppressive medications or radiation within 3 months prior or during the study
- History of pelvic radiation treatment
- Major organ disease, cancer, infection (except acute VVC), or other conditions affecting VVC assessment
- Comorbid conditions preventing safe participation or protocol compliance
- Diabetes mellitus type I or poorly controlled type II diabetes
- Laboratory abnormalities posing additional risk or data interference
- Known HIV, hepatitis B or C infection
- Pregnancy, lactation, or plans to become pregnant during the study
- Planned surgery or medical procedures impacting protocol compliance
- Substance abuse or medical/psychiatric conditions affecting compliance
- Participation in another clinical study within 30 days prior to screening
- Heavy menstrual bleeding or menstrual duration over 7 days
- Current or suspected active urinary tract infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants self-administer vaginal inserts once daily for 14 days, receiving either boric acid or placebo according to their assigned group. They use an electronic diary to record daily symptoms, study drug administration, and other relevant information throughout treatment.
2 in-person visits (Day 7 and Day 15) and daily eDiary entries
Duration - Up to 14 days after treatment
After treatment ends, participants are monitored for safety and efficacy through clinical assessments and symptom evaluations. Follow-up includes a telephone visit and an in-person visit to assess overall outcomes and perform any additional microbiologic evaluations if symptoms persist.
1 telephone visit (Day 21) and 1 in-person visit (Day 28)
Trial Site Locations
Total: 27 locations
1
Alliance for Multispecialty Research - Mobile
Mobile, Alabama, United States, 36608
Actively Recruiting
2
Abby's Research Institute
Phoenix, Arizona, United States, 85031
Withdrawn
3
Applied Research Center of Arkansas Inc.
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
Century Research Institute, Inc
Huntington Park, California, United States, 90255
Active, Not Recruiting
5
Matrix Clinical Research
Los Angeles, California, United States, 90057
Actively Recruiting
6
M3 Wake Research - San Diego
San Diego, California, United States, 92111
Actively Recruiting
7
Integrated Clinical Research LLC
Sherman Oaks, California, United States, 91403
Actively Recruiting
8
Project 4 Research Inc
Miami, Florida, United States, 33125
Actively Recruiting
9
Entrust Clinical Research
Miami, Florida, United States, 33176
Actively Recruiting
10
Felicidad Medical Research, LLC
Miami, Florida, United States, 33184
Actively Recruiting
11
Better Life Clinical Research, LLC
Tampa, Florida, United States, 33607
Actively Recruiting
12
Helping Hands Health Center
Tampa, Florida, United States, 33634
Actively Recruiting
13
One Health Research Clinic Inc.
Johns Creek, Georgia, United States, 30097
Actively Recruiting
14
Leavitt Clinical Research
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
15
Clinical Trials Management, LLC - Northshore
Covington, Louisiana, United States, 70433
Actively Recruiting
16
Praetorian Pharmaceutical Research
Marrero, Louisiana, United States, 70072
Actively Recruiting
17
Revive Research Institute, Inc.
Dearborn Heights, Michigan, United States, 48126
Actively Recruiting
18
Cross Creek Medical Clinic, PA
Fayetteville, North Carolina, United States, 28304
Actively Recruiting
19
Unified Women's Clinical Research - Raleigh
Raleigh, North Carolina, United States, 27607
Actively Recruiting
20
Unified Women's Clinical Research - Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
21
Complete Health Care for Women
Columbus, Ohio, United States, 43231
Actively Recruiting
22
Nexgen Research
Lima, Ohio, United States, 45801
Active, Not Recruiting
23
Chattanooga Medical Research, Chattanooga
Chattanooga, Tennessee, United States, 37412
Actively Recruiting
24
Jackson Clinic
Jackson, Tennessee, United States, 38305
Actively Recruiting
25
TMC Life Research, Inc
Houston, Texas, United States, 77054
Actively Recruiting
26
SMS Clinical Research, LLC
Mesquite, Texas, United States, 75149
Actively Recruiting
27
National Clinical Trials - VA
Reston, Virginia, United States, 20190
Active, Not Recruiting
Research Team
C
Clinical Trial Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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