Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis

NCT ID: NCT03761628

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-07
• Study Completion Date: 2020-01-15

Brief Summary

This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with vulvovaginal candidias (VVC). On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to VVC signs and symptoms and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing VVC symptoms, usability, and adverse events (AEs).

Conditions

Vulvovaginal Candidiasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pHyph, Gedea Pessary

Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.

Group Type: EXPERIMENTAL

pHyph generation I

Intervention Type: DEVICE

A vaginal tablet for the treatment of VVC to be administered every 48 hours

Interventions

pHyph generation I

A vaginal tablet for the treatment of VVC to be administered every 48 hours

Intervention Type: DEVICE

Other Intervention Names

Gedea pessary

Eligibility Criteria

Inclusion Criteria

• Adult, post-menarchal, pre-menopausal women aged 18 years or older
• Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:

1. At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.

2. Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.

• Having decisional capacity and providing written informed consent
• Negative urine pregnancy test at screening
• Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
• Refrain from sexual intercourse or use a condom until Day 7
• Signed informed consent and willing and able to comply with all study requirements

Exclusion Criteria

• Patients with known or apparent signs of other infectious causes of VVC (BV, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening
• Patients who are pregnant or breastfeeding
• Patients who were treated for VVC within the past 14 days
• Patients who are currently receiving antifungal therapy unrelated to VVC or has taken antifungal therapy within the past 14 days
• Patients who have used pH-modifying vaginal products within the last 14 days
• Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening
• Known/previous allergy or hypersensitivity to any product constituent or fluconazole
• Any medical condition that in the Investigator's judgments would make the patient unsuitable for inclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gedea Biotech AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monika Cardell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kvinnokliniken, Region Skåne

Locations

Hoftekliniken

Helsingborg, , Sweden

Annerokliniken

Hofterup, , Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://gedeabiotech.com

Sponsor webpage

Other Identifiers

QRS-CL1-003

Identifier Type: -

Identifier Source: org_study_id