Trial · NCT02418845
A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
NCT02418845, Phase 3, Completed, Symbiomix Therapeutics; results first posted 2021-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis. Trials, record NCT02418845. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02418845
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
- NCT number
- NCT02418845
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 189 participants, actual
- Lead sponsor
- Symbiomix Therapeutics
- Conditions
- Bacterial Vaginosis
- Interventions
- SYM-1219, Placebo
- First posted
- 2015-04-16
- Last updated
- 2021-10-15
- Results first posted
- 2021-04-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Outcome Responder Rate | Study Days 21-30 (End of Study (EOS)) | Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20% |
| Secondary | Clinical Outcome Responder Rate (Interim Visit Only) | Study Days 7-14 (interim) | Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20% |
| Secondary | Gram Stain Slide Nugent Score | Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS) | A score of 0-3 will be considered normal; a score of 4 and above will be considered abnormal |
| Secondary | Therapeutic Outcome Responder Rate | Study days 7-14 (interim) & study days 21-30 (EOS) | A Therapeutic Outcome Responder is defined as a Clinical Outcome Responder with a normal Nugent Score (between 0-3) |
| Secondary | Investigator's Clinical Assessment | Study days 21-30 End of Study (EOS) | Investigator's opinion of the need for additional Bacterial Vaginosis (BV) treatment (Yes or No) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Outcome Responder Rate | Study Days 21-30 (End of Study (EOS)) | Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Outcome Responder Rate (Interim Visit Only) | Study Days 7-14 (interim) | Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Gram Stain Slide Nugent Score | Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS) | Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Therapeutic Outcome Responder Rate | Study days 7-14 (interim) & study days 21-30 (EOS) | Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Investigator's Clinical Assessment | Study days 21-30 End of Study (EOS) | Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Outcome Responder Rate | SYM-1219 | Clinical Outcome Responder | 57 | Participants | |
| Clinical Outcome Responder Rate | Placebo | Clinical Outcome Responder | 11 | Participants | |
| Clinical Outcome Responder Rate | SYM-1219 | Non-Responder | 50 | Participants | |
| Clinical Outcome Responder Rate | Placebo | Non-Responder | 46 | Participants | |
| Clinical Outcome Responder Rate (Interim Visit Only) | SYM-1219 | Clinical Outcome Responder | 62 | Participants | |
| Clinical Outcome Responder Rate (Interim Visit Only) | Placebo | Clinical Outcome Responder | 14 | Participants | |
| Clinical Outcome Responder Rate (Interim Visit Only) | SYM-1219 | Non-Responder | 45 | Participants | |
| Clinical Outcome Responder Rate (Interim Visit Only) | Placebo | Non-Responder | 43 | Participants | |
| Gram Stain Slide Nugent Score | SYM-1219 | Study days 7-14 (interim) / Nugent Score 0-3 | 49 | Participants | |
| Gram Stain Slide Nugent Score | Placebo | Study days 7-14 (interim) / Nugent Score 0-3 | 2 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SYM-1219 | 125 | |
| Overall Study | STARTED | Placebo | 64 | |
| Overall Study | COMPLETED | SYM-1219 | 109 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | NOT COMPLETED | SYM-1219 | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events86
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vulvovaginal mycotic infection | Infections and infestations | SYM-1219 | 9 | 125 | |
| other | Vulvovaginal mycotic infection | Infections and infestations | Placebo | 2 | 64 | |
| other | Vulvovaginal candidiasis | Infections and infestations | SYM-1219 | 8 | 125 | |
| other | Vulvovaginal candidiasis | Infections and infestations | Placebo | 1 | 64 | |
| other | Bronchitis | Infections and infestations | SYM-1219 | 1 | 125 | |
| other | Bronchitis | Infections and infestations | Placebo | 0 | 64 | |
| other | Folliculitis | Infections and infestations | SYM-1219 | 1 | 125 | |
| other | Folliculitis | Infections and infestations | Placebo | 0 | 64 | |
| other | Oral candidiasis | Infections and infestations | SYM-1219 | 1 | 125 | |
| other | Oral candidiasis | Infections and infestations | Placebo | 0 | 64 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SYM-1219 | 0 | 125 |
| Total, all-cause mortality | Placebo | 0 | 64 |
| Total, other adverse events | SYM-1219 | 43 | 125 |
| Total, other adverse events | Placebo | 14 | 64 |
| Total, serious adverse events | SYM-1219 | 2 | 125 |
| Total, serious adverse events | Placebo | 0 | 64 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SYM-1219 vs Placebo: deaths from any cause | Trial comparisons |
| SYM-1219 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02418845
GET https://conductscience.org/api/trials/v1/NCT02418845/results?page=2