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

An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Vulvovaginal Candidiasis

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 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).

Study Overview

• Status: Completed
• Conditions: Vulvovaginal Candidiasis
• Intervention / Treatment: Device: pHyph, Gedea pessary

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Helsingborg, Sweden
    • Hoftekliniken
  • Hofterup, Sweden
    • Annerokliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pHyph, Gedea Pessary; Clinical performance, tolerability, safety and user experience of Gedea Pessary, a slow-release vaginal tablet for the treatment of VVC.	Device: pHyph, Gedea pessary; pHyph is a vaginal tablet for the treatment of VVC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure rate	Defined as the absence of signs and symptoms of VVC in terms of having a composite vulvovaginal signs-and-symptoms (CVVS) score equal to or below 3.; Each of the following 6 vulvovaginal signs and symptoms will be individually scored using the scoring scale below and then added together to determine the CVVS score.Vulvovaginal signs: erythema, edema, or excoriationVulvovaginal symptoms: itching, burning, or irritation; Scoring Scale: each score should be objectively defined. 0 = none (absent)= mild (slight)= moderate (definitely present)= severe (marked, intense)	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients having a reduction in CVVS score	Scoring scale as above	Day 7 compared to Day 0
Usability, measured by patient questionnaire	General assessment of the treatment [1-10, where 10 is very pleased and 1 is very unpleased]	Day 7
Proportion of patients having a recurrence	Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"	Up to day 42

Collaborators and Investigators

• Sponsor: Gedea Biotech AB
• Investigators: Principal Investigator: Monika Cardell, MD, PhD, Kvinnokliniken, Region Skåne

Publications and helpful links

Helpful Links

• Sponsor webpage

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): December 16, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Vaginitis; Vulvovaginitis; Vaginal Yeast Infection; Candidiasis, vulvovaginal; Genital diseases, female; Vaginal diseases
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal
• Other Study ID Numbers: QRS-CL1-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No