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Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219

NCT02452866 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2021-04-13

Study results available
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Summary

This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

SYM-1219

Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water

Sponsors & Collaborators

  • Symbiomix Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02452866 on ClinicalTrials.gov