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NCT02392026

Safety and Tolerability of Metronidazole Gel 1.3%

Completed Phase 4 Last updated 15 August 2023
What this trial tests

Phase 4 trial testing Metronidazole Gel in Vaginosis, Bacterial in 60 participants. Completed in 5 October 2016.

Timeline
12 August 2015
Primary endpoint
5 October 2016
5 October 2016

Quick facts

Lead sponsorInsud Pharma
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment60
Start date12 August 2015
Primary completion5 October 2016
Estimated completion5 October 2016
Sites8 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Insud Pharma — full company profile →

Who can join

Adults 12 to 17, female only, with Vaginosis, Bacterial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel in females 12 to \<18 years for the treatment of bacterial vaginosis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Insud Pharma trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02392026.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing