Clinical trial NCT03761628: Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis
Official title: An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Candidiasis
Keywords: Vaginal Yeast Infection
Candidiasis, vulvovaginal
Genital diseases, female
Vaginitis
Vulvovaginitis
Vaginal diseases
Lead sponsor: Gedea Biotech AB
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Clinical cure rate
timeFrame: Day 7
Secondary outcomes:
measure: Proportion of patients having a reduction in CVVS score
timeFrame: Day 7 compared to Day 0
measure: Usability, measured by patient questionnaire
timeFrame: Day 7
measure: Proportion of patients having a recurrence
timeFrame: Up to day 42
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Hoftekliniken
city: Hofterup
country: Sweden
facility: Annerokliniken
Study officials:
affiliation: Kvinnokliniken, Region Skåne
name: Monika Cardell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: