Phase 2
N=215
A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis
Bacterial Vaginosis
Bottom Line
View on ClinicalTrials.gov: NCT02147899 ↗Enrolled (actual)
215
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Cure of Bacterial Vaginosis — 33; 42; 11; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SYM-1219 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Symbiomix Therapeutics
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure of Bacterial Vaginosis |
64; 62; 62 | — |
| SECONDARY Cure of Bacterial Vaginosis |
64; 62; 62 | — |
| SECONDARY Number of Patients With Therapeutic Cure |
14; 25; 4 | — |
| SECONDARY Number of Patients With a Normal Nugent Score |
15; 25; 4; 49; 37; 58 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02147899). 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.