Bacterial VaginosisPhase 3NCT02418845

A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis

A Phase 3 study testing SYM-1219 in people with Bacterial Vaginosis, run by Symbiomix Therapeutics at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this clinical trial is to test the safety and efficacy of the oral investigational new drug, SYM-1219 for the treatment of 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 189 participants
Where: 21 sitesUnited States
Study dates: 28 May 2015to 5 Dec 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 premenopausal adult females or post menarchal adolescent girls ≥12 years of age in good general health
Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
Off-white (milky or gray), thin, homogeneous vaginal discharge
Vaginal pH ≥ 4.7
Presence of Clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount
A positive 10% KOH Whiff test
Have a Gram stain slide Nugent Score ≥ 4 at the Baseline Visit (Day 1)

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 suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex
Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline Visit (Day 1)

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Study site
Atlanta, Georgia, 30312
Study site
Baltimore, Maryland, 21224
Study site
Birmingham, Alabama, 35294
Study site
Colorado Springs, Colorado, 80910
Study site
Columbus, Ohio, 73212
Study site
Corpus Christi, Texas, 78414
Study site
Denver, Colorado, 80209
Study site
Grand Rapids, Michigan, 49503
Study site
Houston, Texas, 77054
Study site
Jonesboro, Arkansas, 72401
Study site
Leesburg, Florida, 34748
Study site
Miami, Florida, 33161
Study site
Myrtle Beach, South Carolina, 29572
Study site
New Bern, North Carolina, 28562
Study site
Philadelphia, Pennsylvania, 19107
Study site
Philadelphia, Pennsylvania, 19114
Study site
Plainsboro, New Jersey, 08536
Study site
San Diego, California, 92108
Study site
Seattle, Washington, 98105
Study site
Virginia Beach, Virginia, 23456
Study site
Wellington, Florida, 33414

Other trials in United States

About this study

Official title: A Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 2 Grams for the Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis

The purpose of this clinical trial is to test the safety and efficacy of the oral investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.

Conditions: Bacterial Vaginosis
Being tested: SYM-1219, Placebo
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
PlaceboDrug

Study groups in NCT02418845
Study group	Role	What they receive
SYM-1219	Experimental	Administered orally Receives: Drug: SYM-1219
Placebo	Placebo comparator	Administered orally Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Outcome Responder Rate
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20%
Measured: Study Days 21-30 (End of Study (EOS))

Secondary outcomes (4)

Clinical Outcome Responder Rate (Interim Visit Only)
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20%
Measured: Study Days 7-14 (interim)
Gram Stain Slide Nugent Score
A score of 0-3 will be considered normal; a score of 4 and above will be considered abnormal
Measured: Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS)
Therapeutic Outcome Responder Rate
A Therapeutic Outcome Responder is defined as a Clinical Outcome Responder with a normal Nugent Score (between 0-3)
Measured: Study days 7-14 (interim) & study days 21-30 (EOS)
Investigator's Clinical Assessment
Investigator's opinion of the need for additional Bacterial Vaginosis (BV) treatment (Yes or No)
Measured: Study days 21-30 End of Study (EOS)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 May 20155 Dec 2015

First posted16 Apr 2015 (estimated)
Study start28 May 2015
Primary completion5 Oct 2015
Study completion5 Dec 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 189 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02418845
Sponsor's protocol ID: SYM-1219-301
Status last verified: Sep 2021
First submitted: 8 Apr 2015
Last updated: 15 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Bacterial Vaginosis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 2 Grams for the Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
ClinicalTrials.gov ID: NCT02418845
Acronym / sponsor ID: SYM-1219-301
Conditions: Bacterial Vaginosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 189 participants (actual)
Lead sponsor: Symbiomix TherapeuticsIndustry (pharma, biotech, devices)
Study start: 28 May 2015 (actual)
Primary completion: 5 Oct 2015 (actual)
Study completion: 5 Dec 2015 (actual)
First posted: 16 Apr 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.

The purpose of this clinical trial is to test the safety and efficacy of the oral investigational new drug, SYM-1219 for the treatment of bacterial vaginosis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SYM-1219	Experimental	Drug: SYM-1219Administered orally
Placebo	Placebo comparator	Drug: PlaceboAdministered orally

Who may qualify

Ages: 12 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Are premenopausal adult females or post menarchal adolescent girls ≥12 years of age in good general health
Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
Off-white (milky or gray), thin, homogeneous vaginal discharge
Vaginal pH ≥ 4.7
Presence of Clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount

Key exclusion criteria (4 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 suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex
Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline Visit (Day 1)

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-1219	Drug	SYM-1219
Placebo	Drug	Placebo

Primary outcome

Clinical Outcome Responder Rate
Time frame: Study Days 21-30 (End of Study (EOS))
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, \& Clue cells less than 20%

4 secondary outcomes

Clinical Outcome Responder Rate (Interim Visit Only)
Time frame: Study Days 7-14 (interim)
Gram Stain Slide Nugent Score
Time frame: Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS)
Therapeutic Outcome Responder Rate
Time frame: Study days 7-14 (interim) & study days 21-30 (EOS)
Investigator's Clinical Assessment
Time frame: Study days 21-30 End of Study (EOS)

Results and safety

Results posted to the registry on 13 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SYM-1219	125	109
Placebo	64	52

Primary outcome: Clinical Outcome Responder Rate

Time frame: Study Days 21-30 (End of Study (EOS)). Count of participants. Unit: Participants

Measure	SYM-1219 n = 107	Placebo n = 57
Clinical Outcome Responder	57	11
Non-Responder	50	46

Population analysed: Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SYM-1219	2 of 125 (1.6%)	43 of 125 (34.4%)	0 of 125
Placebo	0 of 64 (0%)	14 of 64 (21.9%)	0 of 64

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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.

21 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 21 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 7 inclusion and 4 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 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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. Some participants in this study may receive a placebo. 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?

Clinical Outcome Responder Rate (time frame: Study Days 21-30 (End of Study (EOS))). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02418845.

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 15 Oct 2021.