Bacterial Vaginosis
Conditions
Brief summary
The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.
Detailed description
:This was a Phase 2, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectivenessand safety of SYM-1219 in women with bacterial vaginosis. Patients determined to be eligible for the study were randomized to one of the following treatments: SYM-1219 1 gram orallyas a single dose;SYM-1219 2 grams orally as a single dose;or matching placebo. Patients determined to be eligible based on the clinical assessments at the Baseline visit (Day 1) were randomized in a 1:1:1 ratio and received a singledose of the assigned study treatment on Day 1 under fasted conditions (i.e., no food 2 hours prior to or 1 hour after dosing). The centralized randomization was stratified by the number of reported episodes of BV in the past 12 months (including the current episode): 3 or fewer episodes versus 4 or more episodes. Patients were asked to complete a daily telephone questionnaire on Days1to7 and at the Test of Cure (TOC)/End of Study (EOS)visit. Patients were also contacted by telephone once on Day 8 to 10 to inquire about possible adverse events (AEs). A TOC visit was conducted between Day 21 and 30; or at EOSif the final visit was notconducted between Day 21and30
Interventions
DRUGPlacebo
Oral
DRUGSYM-1219
Oral
Sponsors
Symbiomix Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are females at least 18 years of age in good general health who are not menopausal. * 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 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 |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SYM-1219 Low Dose Administered orally
SYM-1219 | 71 |
| SYM-1219 High Dose Administered orally
SYM-1219 | 72 |
| Placebo Administered orally
Placebo | 72 |
| Total | 215 |
Baseline characteristics
| Characteristic | SYM-1219 Low Dose | SYM-1219 High Dose | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants | 72 Participants | 72 Participants | 215 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 8 Participants | 8 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants | 64 Participants | 64 Participants | 192 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 71 Participants | 72 Participants | 72 Participants | 215 Participants |
| Sex: Female, Male Female | 71 Participants | 72 Participants | 72 Participants | 215 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 72 | 0 / 72 |
| other Total, other adverse events | 9 / 71 | 14 / 72 | 7 / 72 |
| serious Total, serious adverse events | 0 / 71 | 0 / 72 | 0 / 72 |
Outcome results
Primary
Cure of Bacterial Vaginosis
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)
Time frame: Study Days 21-30
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SYM-1219 Low Dose | Cure of Bacterial Vaginosis | Clinical Outcome Responder | 33 Participants |
| SYM-1219 Low Dose | Cure of Bacterial Vaginosis | Non-Responder | 31 Participants |
| SYM-1219 High Dose | Cure of Bacterial Vaginosis | Clinical Outcome Responder | 42 Participants |
| SYM-1219 High Dose | Cure of Bacterial Vaginosis | Non-Responder | 20 Participants |
| Placebo | Cure of Bacterial Vaginosis | Clinical Outcome Responder | 11 Participants |
| Placebo | Cure of Bacterial Vaginosis | Non-Responder | 51 Participants |
Secondary
Cure of Bacterial Vaginosis
Number of subjects with therapeutic cure at Test of Cure (TOC)/End of Study (EOS) (clinical cure + normalization of Nugent score)
Time frame: Study Days 21-30
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SYM-1219 Low Dose | Cure of Bacterial Vaginosis | 64 Participants |
| SYM-1219 High Dose | Cure of Bacterial Vaginosis | 62 Participants |
| Placebo | Cure of Bacterial Vaginosis | 62 Participants |
Secondary
Number of Patients With a Normal Nugent Score
The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.
Time frame: Study Days 21-30
Population: mITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SYM-1219 Low Dose | Number of Patients With a Normal Nugent Score | Nugent Score 0-3 (Normal) | 15 Participants |
| SYM-1219 Low Dose | Number of Patients With a Normal Nugent Score | Nugent Score ≥4 (Abnormal) | 49 Participants |
| SYM-1219 High Dose | Number of Patients With a Normal Nugent Score | Nugent Score 0-3 (Normal) | 25 Participants |
| SYM-1219 High Dose | Number of Patients With a Normal Nugent Score | Nugent Score ≥4 (Abnormal) | 37 Participants |
| Placebo | Number of Patients With a Normal Nugent Score | Nugent Score 0-3 (Normal) | 4 Participants |
| Placebo | Number of Patients With a Normal Nugent Score | Nugent Score ≥4 (Abnormal) | 58 Participants |
Secondary
Number of Patients With Therapeutic Cure
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.
Time frame: Study Days 21-30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SYM-1219 Low Dose | Number of Patients With Therapeutic Cure | 14 Participants |
| SYM-1219 High Dose | Number of Patients With Therapeutic Cure | 25 Participants |
| Placebo | Number of Patients With Therapeutic Cure | 4 Participants |