pHyph treatment for vulvovaginal candidiasis in adult women

A Randomised, Partly Blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Vulvovaginal Candidiasis Compared With an Untreated Control Group

This will test whether pHyph, a vaginal tablet that lowers vaginal pH, helps reduce symptoms of vulvovaginal candidiasis in adult women compared with no treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Gedea Biotech AB (Industry-sponsored)
• Locations: 3 sites (Linköping and 2 other locations)
• Trial ID: NCT07405853 on ClinicalTrials.gov

What this trial studies

This randomized, partly blinded interventional study compares daily pHyph vaginal tablets for 6 days to an untreated control group in adult women with microscope-confirmed VVC. Participants who receive the initial 6-day treatment may receive an additional 6-day course, and outcomes are measured at Day 7 and Day 14 to see change in signs and symptoms. The trial also records adverse events and safety data while requiring participants to avoid other intravaginal products during the study period. The primary focus is clinical improvement of signs and symptoms and device safety.

Who should consider this trial

Good fit: Adult pre‑menopausal women (aged 18 and older) with microscope-confirmed VVC and at least moderate signs or symptoms who can avoid other intravaginal products during the study.

Not a fit: Women who are pregnant, have other untreated vaginal infections, need systemic antifungal therapy for severe or complicated disease, or cannot refrain from other intravaginal products are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, pHyph could offer a safe, non‑antifungal vaginal treatment that reduces VVC symptoms by helping restore normal vaginal pH.

How similar studies have performed: pH‑restoring approaches have biological rationale and some preliminary supportive data, but randomized evidence for devices like pHyph is limited.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the clinical investigation, and to comply with all clinical investigation requirements.
2. Adult, post-menarchal, pre-menopausal women aged 18 years or older.
3. Diagnosis of VVC, defined as:

   * Having a white or creamy vaginal discharge, and
   * at least two signs (erythema, oedema and excoriation) and/or symptoms (itching, burning irritation) of VVC scored as at least 2 = moderate on a scale of 0-3, and
   * potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts upon microscopic analysis.
4. Negative urine pregnancy test at screening.
5. Willing to refrain from using any intravaginal products (e.g., contraceptive creams, gels, foams, sponges, sex toys, lubricants or tampons, etc.) until EOT for the active treatment group (Day 14) or EOI for the no treatment group (Day 7).
6. Willing to use condoms during any sexual intercourse with a male sexual partner until EOT for the active treatment group (Day 14) or EOI for the no treatment group (Day 7).
7. Willing to use a method of contraception, e.g., condoms, hormonal contraception (oral, injectable, implantable, intravaginal, or transdermal), IUD (if a copper IUD is used, it must be combined with a condom) or intrauterine hormone-releasing system (IUS), during any sexual intercourse that might result in pregnancy from Visit 1 (Day 0) until EOI (Day 25 for the active treatment group or Day 7 for the no treatment group) to prevent pregnancy.

Exclusion Criteria:

1. Patients with known or apparent signs of other infectious causes of vaginal infection and/or vaginitis (e.g., BV, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, herpes simplex virus or human papillomavirus) at screening.
2. History of or presence at screening (Day 0) of any other clinically significant disease or disorder, medical/surgical procedure, or trauma, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the clinical investigation, or influence the results or the patient's ability to participate in the clinical investigation.
3. Anticipated menstruation during the first treatment period (Day 0 until Day 7). If a patient is menstruating on Day 0, or if menstruation is anticipated during Days 0 to 7, inclusion can be postponed to an additional visit at a later date when the menstrual bleeding is no longer heavy (light bleeding or brown discharge is acceptable).
4. Patients who are pregnant or breastfeeding.
5. Patients who are planning to conceive within the 25 days of the investigation.
6. Patients who were treated for VVC (both OTC and prescription therapies) within the 14 days preceding screening.
7. Patients who are currently receiving antifungal therapy unrelated to VVC or have received antifungal therapy within the 14 days preceding screening.
8. Patients who have used any pH-modifying vaginal products within the 14 days preceding screening.
9. Patients who have received an investigational drug in a clinical trial within 30 days prior to screening.
10. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, to any of the product components.
11. The Investigator considers the patient unlikely to comply with clinical investigation procedures, restrictions and requirements.

Where this trial is running

Linköping and 2 other locations

• CTC, Ebbe Park — Linköping, Sweden (Recruiting)
• CTC Stockholm — Solna, Sweden (Recruiting)
• Ctc — Uppsala, Sweden (Recruiting)

Study contacts

• Study coordinator: Sten Kornfält

Conditions Vulvovaginal Candidiasis