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

NCT03762083 NA COMPLETED Results posted

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).

Details

Lead sponsor	Gedea Biotech AB
Phase	NA
Status	COMPLETED
Enrolment	24
Start date	Mon Jan 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Nov 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Bacterial Vaginosis

Interventions

• pHyph generation I

Countries

Sweden