An Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Vulvovaginal Candidiasis Compared With an Untreated Control Group

NCT07405853 | Recruiting

• 1 other identifier: VVC-2025
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to learn if pHyph works to reduce signs and symptoms of vulvovaginal candidiasis (thrush). It will also learn about the safety of pHyph. The main questions it aims to answer are:

• Does pHyph reduce the signs and symptoms of vulvovaginal candidiasis after an initial 6 day daily treatment?
• Does an additional 6 day treatment course after the initial one further reduce signs and symptoms of vulvovaginal candidiasis?
• What medical problems do participants have when applying pHyph? Researchers will compare pHyph to no treatment Day 0 to Day 7 to see if pHyph reduces signs and symptoms of vulvovaginal candidiasis. For patients that received initial treatment, researchers will also compare the treatment outcome Day 7 to the treatment outcome after an additional treatment course of pHyph, Day 14. Participants will:
• Apply pHyph every day for 6 days or receive no treatment and visit the clinic 7 days after the initial screening visit. Patients that received treatment will continue with pHyph every day for 6 days and patients that did not receive any treatment will receive standard of care for vulvovaginal candidiasis and leave the study.
• Patients that receive pHyph will visit the clinic Day 0 (screening), Day 7, and Day 14, and have a telephone call Day 25. Patients that do not receive pHyph will visit the clinic Day 0 (screening) and Day 7.
• Keep a diary of their symptoms and confirm that they have applied pHyph.

Conditions

Vulvovaginal Candidiasis (VVC)

Outcome Measures

Primary Outcomes (1)

• The change in CVVS score on Day 7 compared to that on Day 0.

  The primary endpoint is defined as the numerical change in the CVVS score on Day 7 compared to that on Day 0. Each of the of the 6 VVC signs (erythema, oedema and excoriation) and symptoms (itching, burning and irritation) will be scored using the scale below: * 0 = none (absent) * 1 = mild (slight) * 2 = moderate (definitely present) * 3 = severe (marked, intense) The CVVS score is the sum of the six individual scores for vulvovaginal signs and symptoms.

  From enrollment to Day 7

Secondary Outcomes (16)

• The proportion of patients having a reduction in CVVS score

  As applicable from enrollment to Day 14

• The proportion of patients having a reduction in the sum of the three vulvovaginal symptom scores (itching, burning and irritation).

  As applicable from enrollment to Day 25

• The sum of the three vulvovaginal symptom scores (itching, burning and irritation).

  As applicable from enrollment until Day 25

• Individual vulvovaginal symptom scores (itching, burning and irritation).

  As applicable from enrollment to Day 25

• Other vulvovaginal symptom scores, as self-reported by patients.

  As applicable from enrollment to Day 25

Study Arms (2)

pHyph treatment

ACTIVE COMPARATOR

Application of vaginal tablet every day for 6 days

Device: pHyph

No treatment

NO INTERVENTION

Interventions

pHyph DEVICE

pHyph is a vaginal tablet lowering the vaginal pH

pHyph treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give written informed consent for participation in the clinical investigation, and to comply with all clinical investigation requirements.
• Adult, post-menarchal, pre-menopausal women aged 18 years or older.
• 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.
• Negative urine pregnancy test at screening.
• 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).
• 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).
• 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.

You may not qualify if:

• 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.
• 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.
• Patients who are pregnant or breastfeeding.
• Patients who are planning to conceive within the 25 days of the investigation.
• Patients who were treated for VVC (both OTC and prescription therapies) within the 14 days preceding screening.
• Patients who are currently receiving antifungal therapy unrelated to VVC or have received antifungal therapy within the 14 days preceding screening.
• Patients who have used any pH-modifying vaginal products within the 14 days preceding screening.
• Patients who have received an investigational drug in a clinical trial within 30 days prior to screening.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, to any of the product components.
• The Investigator considers the patient unlikely to comply with clinical investigation procedures, restrictions and requirements.

Sponsors & Collaborators

• Gedea Biotech AB: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (3)

CTC, Ebbe Park

Linköping, Sweden

RECRUITING

CTC Stockholm

Solna, Sweden

RECRUITING

CTC

Uppsala, 75237, Sweden

RECRUITING

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Central Study Contacts

Sten Kornfält

CONTACT

+46xxxxxxx; info@gedeabiotech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: March 3, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)