Bacterial Vaginosis
Conditions
Brief summary
This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.
Detailed description
Approximately 325 patients will be enrolled. Patients determined to be eligible for the study will receive SYM-1219 granules containing 2 grams of secnidazole orally as a single dose. Patients determined to be eligible at the Baseline visit will receive a single dose of SYM-1219 granules containing 2 grams of secnidazole in 4 ounces of unsweetened applesauce to be self-administered on Day 1. Patients will be contacted by telephone once between Days 8 to 10 to inquire about possible adverse events. A final study visit will occur on Day 21 to 30 to assess the patient for safety.
Interventions
DRUGSYM-1219
Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water
Sponsors
Symbiomix Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are adult females or postmenarchal adolescent girls ≥ 12 years of age. * Are in good general health as confirmed by a medical history and physical examination, with no known medical or mental health conditions that, in the Investigator's opinion, may interfere with study participation. * Have a negative urine pregnancy test result prior to study treatment initiation. In addition, female patients of childbearing potential must be using an acceptable form of birth control as determined by the Investigator * Agree to abstain from alcohol for 3 days following study treatment. * Have a clinical diagnosis of bacterial vaginosis * Agree not to use vaginal douches or similar products for the duration of the study.
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 menopausal as determined by the Investigator * 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 active genital lesions, including active Herpes simplex lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator * Have consumed any alcohol within 12 hours prior to treatment with study medication. * Have a history of an abnormal Pap smear which required cervical biopsy or cervical cauterization within 3 months of the Baseline visit (Day 1). * Have any history of cervical carcinoma or other carcinomas of the vagina or vulva.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities | 30days | Safety evaluations will be based on the incidence, intensity, and type of AEs of subjects with clinical cure at TOC/EOS (clinical cure basd on amsel + normalization of Nugent score) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SYM-1219 2g Open-Label Study to Evaluate the Safety of A Single Dose of SYM-1219, a Granule Formulation Containing 2 Grams of Secnidazole, for the Treatment of Women and Postmenarchal Adolescent Girls with Bacterial Vaginosis | 325 |
| Total | 325 |
Baseline characteristics
| Characteristic | SYM-1219 2g |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 323 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 72 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 249 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Sex: Female, Male Female | 325 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 321 |
| other Total, other adverse events | 63 / 321 |
| serious Total, serious adverse events | 1 / 321 |
Outcome results
Primary
Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities
Safety evaluations will be based on the incidence, intensity, and type of AEs of subjects with clinical cure at TOC/EOS (clinical cure basd on amsel + normalization of Nugent score)
Time frame: 30days
Population: Safety evaluations were based on the incidence, intensity, and type of AEs,vital signs, and clinical safety laboratory results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SYM-1219 | Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities | Patients with 1 or more TEAE | 95 Participants |
| SYM-1219 | Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities | Pateints with Laboratory Abnormality | 2 Participants |