pH-D Feminine Health, announces it has initiated the first randomized, placebo-controlled, double-blinded Phase 3 clinical trial cleared to proceed by the U.S. Food and Drug Administration (FDA) to clinically validate boric acid suppositories as a potential treatment of yeast infections, with the intent to support submission of a New Drug Application (NDA).
This pivotal study marks a critical milestone in bringing clinical clarity to boric acid suppositories (BAS).
“By sponsoring this pivotal clinical trial, we’re taking the lead to generate the scientific evidence women deserve,” said Deeannah Seymour, co-founder and CEO of pH-D Feminine Health. “This trial marks a decisive step toward providing boric acid for therapeutic use to women through rigorous research and regulatory alignment. Our mission has always been clear: advance the science, honor the data, and make affordable, accessible solutions available to every woman who needs them.”
The American College of Obstetricians and Gynecologists recognizes boric acid as a second-line option in its clinical guidelines for managing vaginitis in non-pregnant women. The Centers for Disease Control and Prevention also supports boric acid efficacy in managing recurrent Vulvovaginal candidiasis (VVC) with 600 mg of BAS administered vaginally in the same population.
“Evaluating boric acid suppositories for therapeutic use addresses a decades-long gap in clinical evidence and could prove groundbreaking for women’s health,” noted Aparna D. Shah, MD, FACOG, board certified in OB/GYN and urogynecology. “The rigorous design of this randomized, placebo-controlled, double-blinded Phase 3 study focuses on the impact of locally administered boric acid for the treatment of vaginal yeast infections in women. We expect this research on safety and efficacy to help further demonstrate the therapeutic potential of boric acid as a locally administered drug.”
Enrollment for the Phase 3 study has begun at nearly 20 trial sites nationwide. The study is anticipated to be completed in June 2026. See ClinicalTrials.Gov.
