Bacterial Vaginosis
Conditions
Brief 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.
Interventions
DRUGSYM-1219
DRUGPlacebo
Sponsors
Symbiomix Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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% |
| 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 |
| 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) |
Countries
United States
Participant flow
Recruitment details
Female post-menarchal participants age 12 and older, inclusive, with a clinical diagnosis of bacterial vaginosis were recruited and enrolled in 21 investigative medical sites throughout the US. Recruitment/enrollment took place between May 4, 2015 and Sep 24, 2015.
Participants by arm
| Arm | Count |
|---|---|
| SYM-1219 2 grams administered orally as a single dose
SYM-1219 | 125 |
| Placebo Administered orally as a single dose
Placebo | 64 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 3 |
| Overall Study | Lost to Follow-up | 7 | 2 |
| Overall Study | Physician Decision | 5 | 5 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | SYM-1219 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 189 Participants | 125 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 33 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 156 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 100 Participants | 67 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 29 Participants | 84 Participants | 55 Participants |
| Region of Enrollment United States | 64 participants | 189 participants | 125 participants |
| Sex: Female, Male Female | 64 Participants | 189 Participants | 125 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 125 | 0 / 64 |
| other Total, other adverse events | 43 / 125 | 14 / 64 |
| serious Total, serious adverse events | 2 / 125 | 0 / 64 |
Outcome results
Primary
Clinical Outcome Responder Rate
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20%
Time frame: Study Days 21-30 (End of Study (EOS))
Population: Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SYM-1219 | Clinical Outcome Responder Rate | Clinical Outcome Responder | 57 Participants |
| SYM-1219 | Clinical Outcome Responder Rate | Non-Responder | 50 Participants |
| Placebo | Clinical Outcome Responder Rate | Clinical Outcome Responder | 11 Participants |
| Placebo | Clinical Outcome Responder Rate | Non-Responder | 46 Participants |
Secondary
Clinical Outcome Responder Rate (Interim Visit Only)
Determined by Normal vaginal discharge, negative 10% KOH Whiff test, & Clue cells less than 20%
Time frame: Study Days 7-14 (interim)
Population: Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SYM-1219 | Clinical Outcome Responder Rate (Interim Visit Only) | Clinical Outcome Responder | 62 Participants |
| SYM-1219 | Clinical Outcome Responder Rate (Interim Visit Only) | Non-Responder | 45 Participants |
| Placebo | Clinical Outcome Responder Rate (Interim Visit Only) | Clinical Outcome Responder | 14 Participants |
| Placebo | Clinical Outcome Responder Rate (Interim Visit Only) | Non-Responder | 43 Participants |
Secondary
Gram Stain Slide Nugent Score
A score of 0-3 will be considered normal; a score of 4 and above will be considered abnormal
Time frame: Study Days 7-14 (interim) & Study Days 21-30 End of Study (EOS)
Population: Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SYM-1219 | Gram Stain Slide Nugent Score | Study days 7-14 (interim) | Nugent Score 0-3 | 49 Participants |
| SYM-1219 | Gram Stain Slide Nugent Score | Study days 7-14 (interim) | Nugent Score 4 or greater | 58 Participants |
| SYM-1219 | Gram Stain Slide Nugent Score | Study days 21-30 (EOS) | Nugent Score 0-3 | 47 Participants |
| SYM-1219 | Gram Stain Slide Nugent Score | Study days 21-30 (EOS) | Nugent Score 4 or greater | 60 Participants |
| Placebo | Gram Stain Slide Nugent Score | Study days 21-30 (EOS) | Nugent Score 4 or greater | 54 Participants |
| Placebo | Gram Stain Slide Nugent Score | Study days 7-14 (interim) | Nugent Score 0-3 | 2 Participants |
| Placebo | Gram Stain Slide Nugent Score | Study days 21-30 (EOS) | Nugent Score 0-3 | 3 Participants |
| Placebo | Gram Stain Slide Nugent Score | Study days 7-14 (interim) | Nugent Score 4 or greater | 55 Participants |
Secondary
Investigator's Clinical Assessment
Investigator's opinion of the need for additional Bacterial Vaginosis (BV) treatment (Yes or No)
Time frame: Study days 21-30 End of Study (EOS)
Population: Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SYM-1219 | Investigator's Clinical Assessment | Additional BV treatment needed | 32 Participants |
| SYM-1219 | Investigator's Clinical Assessment | No additional treatment needed | 68 Participants |
| SYM-1219 | Investigator's Clinical Assessment | Missing | 7 Participants |
| Placebo | Investigator's Clinical Assessment | Additional BV treatment needed | 38 Participants |
| Placebo | Investigator's Clinical Assessment | No additional treatment needed | 16 Participants |
| Placebo | Investigator's Clinical Assessment | Missing | 3 Participants |
Secondary
Therapeutic Outcome Responder Rate
A Therapeutic Outcome Responder is defined as a Clinical Outcome Responder with a normal Nugent Score (between 0-3)
Time frame: Study days 7-14 (interim) & study days 21-30 (EOS)
Population: Modified Intent-to-Treat (mITT) population includes all randomized participants who met all inclusion/exclusion criteria.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SYM-1219 | Therapeutic Outcome Responder Rate | Study days 7-14 (interim) | Therapeutic Outcome Responder | 37 Participants |
| SYM-1219 | Therapeutic Outcome Responder Rate | Study days 7-14 (interim) | Non-Responder | 70 Participants |
| SYM-1219 | Therapeutic Outcome Responder Rate | Study days 21-30 (EOS) | Therapeutic Outcome Responder | 37 Participants |
| SYM-1219 | Therapeutic Outcome Responder Rate | Study days 21-30 (EOS) | Non-Responder | 70 Participants |
| Placebo | Therapeutic Outcome Responder Rate | Study days 21-30 (EOS) | Non-Responder | 55 Participants |
| Placebo | Therapeutic Outcome Responder Rate | Study days 7-14 (interim) | Therapeutic Outcome Responder | 2 Participants |
| Placebo | Therapeutic Outcome Responder Rate | Study days 21-30 (EOS) | Therapeutic Outcome Responder | 2 Participants |
| Placebo | Therapeutic Outcome Responder Rate | Study days 7-14 (interim) | Non-Responder | 55 Participants |