NCT04640922: Nefertiti

Clinical Performance and Safety of the Gedea Pessary in Adult Women With Bacterial Vaginosis

Completed NA Last updated 18 August 2022

What this trial tests

NA trial testing Gedea Pessary pHyph in Bacterial Vaginosis in 152 participants. Completed in 1 June 2022.

Timeline

27 January 2020

Primary endpoint
31 January 2022

1 June 2022

Quick facts

Lead sponsor	Gedea Biotech AB
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	152
Start date	27 January 2020
Primary completion	31 January 2022
Estimated completion	1 June 2022
Sites	5 locations across Sweden, United Kingdom

Drugs / interventions tested

• Gedea Pessary pHyph
• Placebo

Conditions studied

• Bacterial Vaginosis — all drugs for Bacterial Vaginosis →

Sponsor

Gedea Biotech AB — full company profile →

Who can join

18 and older, female only, with Bacterial Vaginosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomised, double-blind placebo-controlled multi-centre study to evaluate clinical performance, safety and local tolerability of initial and preventive treatment with Gedea Pessary in adult women with confirmed BV.

The study population will consist of post-menarchal, pre-menopausal females 18 years or older seeking for BV symptoms (fishy smell, irritation and burning).

Patients will be recruited at study sites' gynaecological and sexual health clinics and a total of 150 patients are planned to be randomised in the study.

On Day 0, patients will have gynaecological examination, vaginal samples taken, and will be randomised in a 4:1 relation to receive treatment with 6 doses of the Gedea Pessary or a vehicle control (placebo) to be self-administered daily (Days 0 to 5). Patients will be re examined at Day 7 (+2 days) for clinical cure rate.

Patients that are clinically cured at Day 7 will continue to the second part of the study and will be randomised in a 1:1 relation to either Gedea Pessary or placebo treatment, to be self administered once a week for a duration of 126 days.

Patients not clinically cured at Day 7 will be offered rescue treatment (metronidazole) for 7 days. They will return at Day 14 for clinical assessment and sampling for microbiome and mycobiome analysis, and if cured they will be assessed for recurrence up to Day 128. Patients that are not cured at Day 14 will be discontinued from the study.

Patients that are clinically cured at Day 7 and continuing in Part 2 will be followed up until confirmed recurrence or Day 128 if no recurrence. Vaginal samples will be taken by self-swab on Days 35, 63 and 91, a visit to the clinic will be performed at Day 63 and telephone follow up will be done at Days 35 and 91. Vaginal samples will also be taken at the visit on the Day of potential recurrence and/or at Day 128 if no recurrence.

Vaginal samples will be used for confirming the diagnosis (Nugent score on Day 0 and Day 7) and sequencing analysis of the vaginal microbiome and mycobiome (Days 0, 7, 35, 63, 91 and Day of confirmed recurrence or Day 128 if no recurrence).

Patient follow-up as regards to patient questionnaire/usability, AEs and BV recurrence notification will be handled with a mobile phone application. In case of a suspected BV recurrence, the patient should return to the clinic for confirmation of BV diagnosis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. pHyph, a novel antibiotic-free treatment for bacterial vaginosis, promotes Lactobacillus growth and reduces the abundance of pathogens in the vagina.
   Lahtinen E, Hugerth LW, Edfeldt G, Säfholm A, et al · · 2025 · PMID 41321665 · DOI 10.1016/j.xagr.2025.100566