RecruitingNot ApplicableNCT07405853

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

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

Sponsor

Gedea Biotech AB

Enrollment

48 participants

Start Date

Mar 3, 2026

Study Type

INTERVENTIONAL

Conditions

Vulvovaginal Candidiasis (VVC)

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria10

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.

Exclusion Criteria11

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.
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).
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.

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