Trial · NCT02147899

A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

NCT02147899, Phase 2, Completed, Symbiomix Therapeutics; results first posted 2017-12-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis. Trials, record NCT02147899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02147899

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis
NCT number: NCT02147899
Status: Completed
Phases: Phase 2
Enrollment: 215 participants, actual
Lead sponsor: Symbiomix Therapeutics
Conditions: Bacterial Vaginosis
Interventions: SYM-1219, Placebo
First posted: 2014-05-28
Last updated: 2020-11-13
Results first posted: 2017-12-14

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cure of Bacterial Vaginosis	Study Days 21-30	Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH "Whiff" test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount. (Number of subjects with clinical cure at TOC/EOS)
Secondary	Cure of Bacterial Vaginosis	Study Days 21-30	Number of subjects with therapeutic cure at Test of Cure (TOC)/End of Study (EOS) (clinical cure + normalization of Nugent score)
Secondary	Number of Patients With Therapeutic Cure	Study Days 21-30	Clinical Cure and Normalization of the Nugent score. The Nugent score is based on a microscopic assessment of a Gram stain of the vaginal fluid.
Secondary	Number of Patients With a Normal Nugent Score	Study Days 21-30	The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cure of Bacterial Vaginosis	Study Days 21-30	mITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Cure of Bacterial Vaginosis	Study Days 21-30	Safety Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Therapeutic Cure	Study Days 21-30		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With a Normal Nugent Score	Study Days 21-30	mITT	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Cure of Bacterial Vaginosis	SYM-1219 Low Dose	Clinical Outcome Responder	33	Participants
Cure of Bacterial Vaginosis	SYM-1219 High Dose	Clinical Outcome Responder	42	Participants
Cure of Bacterial Vaginosis	Placebo	Clinical Outcome Responder	11	Participants
Cure of Bacterial Vaginosis	SYM-1219 Low Dose	Non-Responder	31	Participants
Cure of Bacterial Vaginosis	SYM-1219 High Dose	Non-Responder	20	Participants
Cure of Bacterial Vaginosis	Placebo	Non-Responder	51	Participants
Cure of Bacterial Vaginosis	SYM-1219 Low Dose		64	Participants
Cure of Bacterial Vaginosis	SYM-1219 High Dose		62	Participants
Cure of Bacterial Vaginosis	Placebo		62	Participants
Number of Patients With Therapeutic Cure	SYM-1219 Low Dose		14	Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SYM-1219 Low Dose	71
Overall Study	STARTED	SYM-1219 High Dose	72
Overall Study	STARTED	Placebo	72
Overall Study	COMPLETED	SYM-1219 Low Dose	71
Overall Study	COMPLETED	SYM-1219 High Dose	72
Overall Study	COMPLETED	Placebo	72
Overall Study	NOT COMPLETED	SYM-1219 Low Dose	0
Overall Study	NOT COMPLETED	SYM-1219 High Dose	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events87

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
other	headache	Nervous system disorders	SYM-1219 Low Dose	1	71
other	headache	Nervous system disorders	SYM-1219 High Dose	1	72
other	headache	Nervous system disorders	Placebo	0	72
other	dizziness	Nervous system disorders	SYM-1219 Low Dose	0	71
other	dizziness	Nervous system disorders	SYM-1219 High Dose	1	72
other	dizziness	Nervous system disorders	Placebo	0	72
other	dysgeusia	Nervous system disorders	SYM-1219 Low Dose	0	71
other	dysgeusia	Nervous system disorders	SYM-1219 High Dose	1	72
other	dysgeusia	Nervous system disorders	Placebo	0	72
other	Vaginal discharge	Reproductive system and breast disorders	SYM-1219 Low Dose	0	71

1 to 10 of 87Source ClinicalTrials.gov

See all 87 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SYM-1219 Low Dose	0	71
Total, all-cause mortality	SYM-1219 High Dose	0	72
Total, all-cause mortality	Placebo	0	72
Total, other adverse events	SYM-1219 Low Dose	9	71
Total, other adverse events	SYM-1219 High Dose	14	72
Total, other adverse events	Placebo	7	72
Total, serious adverse events	SYM-1219 Low Dose	0	71
Total, serious adverse events	SYM-1219 High Dose	0	72
Total, serious adverse events	Placebo	0	72

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28697102	DERIVED

Source PubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02147899

GET https://conductscience.org/api/trials/v1/NCT02147899/events?page=2

API reference For AI assistants