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

Gedea Biotech

Status: Completed

Conditions: Vulvovaginal Candidiasis

Treatments: Device: pHyph generation I

Study type: Interventional

Funder types: Industry

Identifiers

NCT03761628

QRS-CL1-003

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

pHyph, Gedea Pessary

Experimental group

Description:

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

Treatment:

Device: pHyph generation I