NCT03761628

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Gedea Biotech AB · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DEVICE	pHyph generation I	A vaginal tablet for the treatment of VVC to be administered every 48 hours

Timeline

• Start date: 2019-01-07
• Primary completion: 2019-12-16
• Completion: 2020-01-15
• First posted: 2018-12-03
• Last updated: 2025-07-25
• Results posted: 2025-07-25

Locations

2 sites across 1 country: Sweden