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

Sponsor

Gedea Biotech AB (Industry)

Overall Status

Completed

CT.gov ID

NCT03761628

Collaborator

(none)

Enrollment

Locations

Arm

12.3

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Vulvovaginal Candidiasis	Device: pHyph, Gedea pessary	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 7, 2019

Actual Primary Completion Date :

Dec 16, 2019

Actual Study Completion Date :

Jan 15, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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) = mild (slight) = moderate (definitely present) = severe (marked, intense)

Secondary Outcome Measures

Proportion of patients having a reduction in CVVS score [Day 7 compared to Day 0]
Scoring scale as above
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 recurrence [Up to day 42]
Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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:

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.
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