Phase 3
Completed N=325
Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
Source: ClinicalTrials.gov NCT02452866 ↗Enrolled (actual)
325
Serious AEs
0.3%
Results posted
Apr 2021
Primary outcomePrimary: Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities — 95; 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities |
95; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02452866). 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. Informational only — not medical advice.