NCT03762083

Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis

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

• 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 confirmed bacterial vaginosis (BV) according to fulfillment of at least 3 of the 4 Amsel criteria. 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 3 Amsel criteria (the criterion: "pH of vaginal fluid above 4.5" is only included at study inclusion for diagnosis), 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 BV symptoms, usability, and adverse events (AEs).

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DEVICE	pHyph generation I	A vaginal tablet for the treatment of BV with administration every 48 hours.

Timeline

• Start date: 2019-01-07
• Primary completion: 2019-10-22
• Completion: 2019-11-18
• First posted: 2018-12-03
• Last updated: 2025-07-25
• Results posted: 2025-07-25

Locations

2 sites across 1 country: Sweden