Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis
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|ClinicalTrials.gov Identifier: NCT03761628|
Recruitment Status : Completed
First Posted : December 3, 2018
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Vulvovaginal Candidiasis||Device: pHyph, Gedea pessary||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Vulvovaginal Candidiasis|
|Actual Study Start Date :||January 7, 2019|
|Actual Primary Completion Date :||December 16, 2019|
|Actual Study Completion Date :||January 15, 2020|
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
- Clinical cure rate [ Time Frame: 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)
- Proportion of patients having a reduction in CVVS score [ Time Frame: Day 7 compared to Day 0 ]Scoring scale as above
- Usability, measured by patient questionnaire [ Time Frame: 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 [ Time Frame: Up to day 42 ]Proportion of patients answering [Yes] to the question "Have the symptoms recurred?"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761628
|Principal Investigator:||Monika Cardell, MD, PhD||Kvinnokliniken, Region Skåne|