Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
Multi-center, Prospective, Open-Label Study to Evaluate the Safety of A Single Dose of SYM-1219, a Granule Formulation Containing 2 Grams of Secnidazole, for the Treatment of Women and Postmenarchal Adolescent Girls With Bacterial Vaginosis
1 other identifier
interventional
325
1 country
40
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2015
Shorter than P25 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2015
CompletedFirst Posted
Study publicly available on registry
May 25, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
April 13, 2021
CompletedApril 13, 2021
December 1, 2020
4 months
May 19, 2015
October 19, 2020
March 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities
Safety evaluations will be based on the incidence, intensity, and type of AEs of subjects with clinical cure at TOC/EOS (clinical cure basd on amsel + normalization of Nugent score)
30days
Study Arms (1)
SYM-1219
EXPERIMENTALAll pateints recieved single dose SYM-1219 Containing 2 Grams of Secnidazole
Interventions
Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water
Eligibility Criteria
You may qualify if:
- Are adult females or postmenarchal adolescent girls ≥ 12 years of age.
- Are in good general health as confirmed by a medical history and physical examination, with no known medical or mental health conditions that, in the Investigator's opinion, may interfere with study participation.
- Have a negative urine pregnancy test result prior to study treatment initiation. In addition, female patients of childbearing potential must be using an acceptable form of birth control as determined by the Investigator
- Agree to abstain from alcohol for 3 days following study treatment.
- Have a clinical diagnosis of bacterial vaginosis
- Agree not to use vaginal douches or similar products for the duration of the study.
You may not qualify if:
- Are pregnant, lactating, or planning to become pregnant during the study.
- Are menstruating or have vaginal bleeding at the Baseline visit (Day 1).
- Are menopausal as determined by the Investigator
- Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex
- Have active genital lesions, including active Herpes simplex lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator
- Have consumed any alcohol within 12 hours prior to treatment with study medication.
- Have a history of an abnormal Pap smear which required cervical biopsy or cervical cauterization within 3 months of the Baseline visit (Day 1).
- Have any history of cervical carcinoma or other carcinomas of the vagina or vulva.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Phoenix, Arizona, 85018, United States
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
Colorado Springs, Colorado, 80907, United States
Unknown Facility
Denver, Colorado, 80209, United States
Unknown Facility
Groton, Connecticut, 06340, United States
Unknown Facility
Clearwater, Florida, 33759, United States
Unknown Facility
Leesburg, Florida, 34748, United States
Unknown Facility
Miami, Florida, 33186, United States
Unknown Facility
North Miami, Florida, 33161, United States
Unknown Facility
Plantation, Florida, 33324, United States
Unknown Facility
Wellington, Florida, 33414, United States
Unknown Facility
Atlanta, Georgia, 30312, United States
Unknown Facility
Columbus, Georgia, 31904, United States
Unknown Facility
Roswell, Georgia, 30075, United States
Unknown Facility
Shawnee Mission, Kansas, 66218, United States
Unknown Facility
Baltimore, Maryland, 21224, United States
Unknown Facility
Fall River, Massachusetts, 02720, United States
Unknown Facility
Grand Rapids, Michigan, 49503, United States
Unknown Facility
Kalamazoo, Michigan, 49009, United States
Unknown Facility
Saginaw, Michigan, 48604, United States
Unknown Facility
Plainsboro, New Jersey, 08536, United States
Unknown Facility
New Bern, North Carolina, 28562, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Columbus, Ohio, 43213, United States
Unknown Facility
Columbus, Ohio, 43231, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Philadelphia, Pennsylvania, 19114, United States
Unknown Facility
Myrtle Beach, South Carolina, 29572, United States
Unknown Facility
Jackson, Tennessee, 38305, United States
Unknown Facility
Corpus Christi, Texas, 78414, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Houston, Texas, 77054, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Virginia Beach, Virginia, 23456, United States
Unknown Facility
Seattle, Washington, 98104, United States
Unknown Facility
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP Clinical Operations
- Organization
- Symbiomix Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2015
First Posted
May 25, 2015
Study Start
June 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
April 13, 2021
Results First Posted
April 13, 2021
Record last verified: 2020-12