Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219

Study Overview
=================
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.

Official Title
-----------------
Multi-center, Prospective, 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

Conditions
-----------------
Bacterial Vaginosis

Intervention / Treatment
-----------------
* Drug: SYM-1219


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYM-1219<br>All pateints recieved single dose SYM-1219 Containing 2 Grams of Secnidazole | Drug: SYM-1219<br>* Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water<br>* Other names: Secnidazole;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 30days |