A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

Status Completed

Clinical Trial Summary

The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.

Clinical Trial Description

:This was a Phase 2, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectivenessand safety of SYM-1219 in women with bacterial vaginosis. Patients determined to be eligible for the study were randomized to one of the following treatments: SYM-1219 1 gram orallyas a single dose;SYM-1219 2 grams orally as a single dose;or matching placebo. Patients determined to be eligible based on the clinical assessments at the Baseline visit (Day 1) were randomized in a 1:1:1 ratio and received a singledose of the assigned study treatment on Day 1 under fasted conditions (i.e., no food 2 hours prior to or 1 hour after dosing). The centralized randomization was stratified by the number of reported episodes of BV in the past 12 months (including the current episode): 3 or fewer episodes versus 4 or more episodes. Patients were asked to complete a daily telephone questionnaire on Days1to7 and at the Test of Cure (TOC)/End of Study (EOS)visit. Patients were also contacted by telephone once on Day 8 to 10 to inquire about possible adverse events (AEs). A TOC visit was conducted between Day 21 and 30; or at EOSif the final visit was notconducted between Day 21and30 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02147899
Study type	Interventional
Source	Symbiomix Therapeutics
Contact
Status	Completed
Phase	Phase 2
Start date	May 2014
Completion date	October 2014

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
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	`NCT01471457` - Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis	Phase 2/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