Bacterial VaginosisPhase 3NCT02452866
Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
A Phase 3 study testing SYM-1219 in people with Bacterial Vaginosis, run by Symbiomix Therapeutics at 40 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- SYM-1219
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 40 sitesUnited States
- Study dates
- Jun 2015to Oct 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Study site
Atlanta, Georgia, 30312
Study site
Baltimore, Maryland, 21224
Study site
Birmingham, Alabama, 35294
Study site
Clearwater, Florida, 33759
Study site
Colorado Springs, Colorado, 80907
Study site
Columbus, Georgia, 31904
Study site
Columbus, Ohio, 43213
Study site
Columbus, Ohio, 43231
Study site
Corpus Christi, Texas, 78414
Study site
Dallas, Texas, 75231
Study site
Denver, Colorado, 80209
Study site
Fall River, Massachusetts, 02720
Study site
Grand Rapids, Michigan, 49503
Study site
Groton, Connecticut, 06340
Study site
Houston, Texas, 77054
Study site
Jackson, Tennessee, 38305
Study site
Jonesboro, Arkansas, 72401
Study site
Kalamazoo, Michigan, 49009
Study site
La Mesa, California, 91942
Study site
Leesburg, Florida, 34748
Study site
Miami, Florida, 33186
Study site
Myrtle Beach, South Carolina, 29572
Study site
New Bern, North Carolina, 28562
Study site
Norfolk, Virginia, 23507
Study site
North Miami, Florida, 33161
Study site
Philadelphia, Pennsylvania, 19107
Study site
Philadelphia, Pennsylvania, 19114
Study site
Phoenix, Arizona, 85018
Study site
Plainsboro, New Jersey, 08536
Study site
Plantation, Florida, 33324
Study site
Roswell, Georgia, 30075
Study site
Saginaw, Michigan, 48604
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92108
Study site
Seattle, Washington, 98104
Study site
Seattle, Washington, 98105
Study site
Shawnee Mission, Kansas, 66218
Study site
Virginia Beach, Virginia, 23456
Study site
Wellington, Florida, 33414
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: 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
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.
Read the detailed description
Approximately 325 patients will be enrolled. Patients determined to be eligible for the study will receive SYM-1219 granules containing 2 grams of secnidazole orally as a single dose.
Patients determined to be eligible at the Baseline visit will receive a single dose of SYM-1219 granules containing 2 grams of secnidazole in 4 ounces of unsweetened applesauce to be self-administered on Day 1. Patients will be contacted by telephone once between Days 8 to 10 to inquire about possible adverse events. A final study visit will occur on Day 21 to 30 to assess the patient for safety.
- Conditions
- Bacterial Vaginosis
- Being tested
- SYM-1219
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYM-1219Drug
Also called Secnidazole
Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water
| Study group | Role | What they receive |
|---|---|---|
| SYM-1219 | Experimental | All pateints recieved single dose SYM-1219 Containing 2 Grams of Secnidazole Receives: Drug: SYM-1219 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symbiomix Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452866
- Sponsor's protocol ID
- SYM-1219-350
- Status last verified
- Dec 2020
- First submitted
- 19 May 2015
- Last updated
- 13 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02452866
- Acronym / sponsor ID
- SYM-1219-350
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Symbiomix TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Posted 13 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 325 patients will be enrolled. Patients determined to be eligible for the study will receive SYM-1219 granules containing 2 grams of secnidazole orally as a single dose.
Patients determined to be eligible at the Baseline visit will receive a single dose of SYM-1219 granules containing 2 grams of secnidazole in 4 ounces of unsweetened applesauce to be self-administered on Day 1. Patients will be contacted by telephone once between Days 8 to 10 to inquire about possible adverse events. A final study visit will occur on Day 21 to 30 to assess the patient for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYM-1219 | Experimental | Drug: SYM-1219All pateints recieved single dose SYM-1219 Containing 2 Grams of Secnidazole |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYM-1219Also: SecnidazoleAdministered with 4 ounces of unsweetened applesauce, and 8 ounces of water | Drug | SYM-1219 |
Primary outcome
Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities
Time frame: 30days
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SYM-1219 in people with Bacterial Vaginosis, run by Symbiomix Therapeutics at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities (time frame: 30days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021; AzTrials last refreshed its copy on 4 Nov 2026.