A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

Study Overview
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Brief Summary
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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
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: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

Official Title
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A Phase 2, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 for the Treatment of Women With Bacterial Vaginosis

Conditions
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Bacterial Vaginosis

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


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYM-1219 Low Dose<br>Administered orally | Drug: SYM-1219<br>* Oral<br>* Other names: Secnidazole;|
| Experimental: SYM-1219 High Dose<br>Administered orally | Drug: SYM-1219<br>* Oral<br>* Other names: Secnidazole;|
| Placebo Comparator: Placebo<br>Administered orally | Drug: Placebo<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Study Days 21-30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Study Days 21-30 | 
| 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. | Study Days 21-30 | 
| Number of Patients With a Normal Nugent Score | The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid. | Study Days 21-30 |