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

NCT07405853 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-14

No results posted yet for this study

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)

Interventions

DEVICE

pHyph

pHyph is a vaginal tablet lowering the vaginal pH

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Gedea Biotech AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07405853 on ClinicalTrials.gov