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

Not Applicable

Completed

• Conditions: Vulvovaginal Candidiasis
• Interventions: Device: pHyph, Gedea pessary

• Registration Number: NCT03761628
• Lead Sponsor: Gedea Biotech AB

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 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-03
• Study Start: 2019-01-07
• Primary Completion: 2019-12-16
• Status Verified: 2020-01
• Study Completion: 2020-01-15
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical cure rate	Day 7	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 excoriation; * Vulvovaginal symptoms: itching, burning, or irritation; * Scoring Scale: each score should be objectively defined. 0 = none (absent); 1. = mild (slight); 2. = moderate (definitely present); 3. = severe (marked, intense)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hoftekliniken; 🇸🇪 Helsingborg, Sweden

Annerokliniken; 🇸🇪 Hofterup, Sweden