Actively Recruiting
Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis
Led by pH-D Feminine Health LLC · Updated on 2026-04-02
400
Participants Needed
27
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 a vulvar signs and symptoms score of 4 or higher
- Cervical cancer screening negative or clinically insignificant within 1 year for patients aged 21 and older
- Suitable candidates for vaginal treatment who can self-insert the study drug and comfortable with pelvic exams
- Willing and able to provide informed consent or assent (for ages 12 to 17)
- Able to comply with protocol requirements and restrictions
- Willing to authorize use of protected health information
- Use one of specified contraceptive methods through Day 28 if of childbearing potential
- Willing to avoid tampon or menstrual cup use during treatment (Day 1 to Day 14)
- Willing to abstain from oral intercourse during treatment (Day 1 to Day 14)
You will not qualify if you...
- Known or suspected active infections other than VVC, including bacterial vaginosis, chlamydia, gonorrhea, trichomoniasis, herpes, syphilis, or others
- Vaginal rejuvenation procedure within 4 weeks prior to screening or planned before study completion
- Evaluation or treatment for abnormal cervical cytology or high-risk HPV during the study
- Diagnosis of bacterial vaginosis based on Amsel's criteria
- Current or history of cervical, vaginal, or vulvar cancer treatment
- 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 within 14 days prior to screening or during the study
- Use of any vaginal or vulvar products like estrogen, lubricants, moisturizers, douches, or spermicides within 7 days prior to screening through Day 28
- Unwillingness to avoid intravaginal products during treatment period
- Current immunocompromising conditions like HIV or end-stage renal disease
- Use of immunosuppressive medication 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 study participation
- Diabetes type I or poorly controlled type II diabetes
- Laboratory abnormalities increasing risk or interfering with data
- Known HIV, hepatitis B or C infection or positive tests
- Pregnancy, lactation, or planning pregnancy during the study
- Planned surgery or medical procedures impacting study compliance
- Recent or current substance abuse or psychiatric conditions impacting compliance
- Participation in another clinical study within 30 days prior to screening
- Expectation or current heavy menstrual bleeding or menses longer than 7 days
- Suspected or current urinary tract infection at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively 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
Actively 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
Actively Recruiting
Research Team
C
Clinical Trial Manager
CONTACT
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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