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

Status Completed

Clinical Trial 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 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03762083
Study type	Interventional
Source	Gedea Biotech AB
Contact
Status	Completed
Phase	N/A
Start date	January 7, 2019
Completion date	November 18, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03930745` - Suppression Of Bacterial Vaginosis (BV) [SUBVert]	Phase 2
Completed	`NCT02863536` - A Study of the New Medical Device Polybactum®	N/A
Completed	`NCT03187457` - PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"	N/A
Recruiting	`NCT02185456` - Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis	Phase 0
Completed	`NCT02150655` - Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women	Phase 0
Completed	`NCT01450462` - Vitamin D and Sexual Health	N/A
Recruiting	`NCT01558388` - Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy	Phase 4
Completed	`NCT01471457` - Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis	Phase 2/Phase 3
Not yet recruiting	`NCT00889356` - Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis	Phase 3
Completed	`NCT00556179` - Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis	Phase 4
Completed	`NCT00545181` - Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial	N/A
Completed	`NCT02236156` - Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)	Phase 3
Not yet recruiting	`NCT05434104` - The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study	N/A
Completed	`NCT01335373` - Observational Program Neo-Penotran® Forte	N/A
Completed	`NCT00752193` - Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.	N/A
Active, not recruiting	`NCT00536848` - The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients	Phase 2/Phase 3
Completed	`NCT00510614` - Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study	Phase 0
Suspended	`NCT00207480` - Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women	Phase 1
Recruiting	`NCT05278130` - Serial Screening and Treatment of Bacterial Vaginosis Trial	N/A
Completed	`NCT02905890` - The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis	Phase 4