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

Vulvovaginal Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761628
• Other study ID #: QRS-CL1-003
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2020
• Source: Gedea Biotech AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 15, 2020
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Device:
• pHyph, Gedea pessary
pHyph is a vaginal tablet for the treatment of VVC

Locations

Country	Name	City	State
Sweden	Hoftekliniken	Helsingborg
Sweden	Annerokliniken	Hofterup

Sponsors (1)

Lead Sponsor	Collaborator
Gedea Biotech AB

Country where clinical trial is conducted

Sweden, 

Outcome

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

External Links

•   Sponsor webpage