pH-D Feminine Health Launches Pivotal Phase 3 Trial for Boric Acid Suppositories

pH-D Feminine Health Initiates Groundbreaking Phase 3 Clinical Trial

In a monumental stride towards advancing women's health, pH-D Feminine Health has launched its first randomized and placebo-controlled Phase 3 clinical trial for boric acid suppositories, gaining clearance from the U.S. Food and Drug Administration (FDA). This trial aims to thoroughly evaluate the safety and effectiveness of boric acid as a potential therapeutic solution for yeast infections, with the hope of ultimately supporting the submission of a New Drug Application (NDA).

Deeannah Seymour, co-founder and CEO of pH-D Feminine Health, emphasized the significance of this initiative, stating, "By sponsoring this pivotal clinical trial, we're taking the lead to generate the scientific evidence women deserve." This endeavor highlights the company's commitment to making clinically validated treatments accessible and affordable for women.

Boric acid has been recognized in the American College of Obstetricians and Gynecologists' clinical guidelines as a second-line treatment option for managing vaginitis in non-pregnant women. Furthermore, the Centers for Disease Control and Prevention (CDC) has acknowledged its efficacy in treating recurrent Vulvovaginal candidiasis (VVC), recommending a dosage of 600 mg for vaginal administration to the affected demographic.

Dr. Aparna D. Shah, a board-certified OB/GYN and urogynecologist, noted the trial's importance, stating, "Evaluating boric acid suppositories for therapeutic use addresses a decades-long gap in clinical evidence and could prove groundbreaking for women's health." The study's design, which incorporates rigorous randomized, placebo-controlled methodologies, will investigate the effects of locally administered boric acid on vaginal yeast infections in women, contributing to a better understanding of its therapeutic potential.

Enrollment for the Phase 3 clinical trial has commenced across nearly 20 trial sites nationwide, with researchers anticipating completion by June 2026. This trial represents a significant advancement not only for pH-D Feminine Health but for the future of women's healthcare, as it underscores a shift towards more validated therapeutic options.

Founded in 2014 and owned by women, pH-D Feminine Health has established itself as a leader in the development of boric acid suppositories, underscoring its commitment to women's intimate health. The boric acid vaginal suppository remains an investigational product and has not yet received FDA approval for the treatment of vulvovaginal candidiasis. However, the company’s retail offerings are available online and across the United States.

As the trial progresses, pH-D Feminine Health is poised to reshape the landscape of women's health, bringing scientifically backed solutions to the forefront. For more updates, you can visit their website at pH-D Feminine Health or follow them on social media for continued discussions on women's health issues and innovations in treatment.

For media inquiries, contact Kellee Johnson at 312-751-3959 or via email at [email protected].

This trial could pave the way for many women seeking effective treatments for yeast infections, representing hope for an underserved area in women's health.