Phase 3
N=189
A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis
Bacterial Vaginosis
Bottom Line
View on ClinicalTrials.gov: NCT02418845 ↗Enrolled (actual)
189
Serious AEs
1.1%
Results posted
Apr 2021
Primary outcome: Primary: Clinical Outcome Responder Rate — 57; 11; 50; 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SYM-1219 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Symbiomix Therapeutics
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Outcome Responder Rate |
57; 11; 50; 46 | — |
| SECONDARY Clinical Outcome Responder Rate (Interim Visit Only) |
62; 14; 45; 43 | — |
| SECONDARY Gram Stain Slide Nugent Score |
49; 2; 58; 55; 47; 3 | — |
| SECONDARY Therapeutic Outcome Responder Rate |
37; 2; 70; 55; 37; 2 | — |
| SECONDARY Investigator's Clinical Assessment |
32; 38; 68; 16; 7; 3 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02418845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.