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

Symbiomix Therapeutics

Status and phase

Completed

Phase 3

Conditions

Bacterial Vaginosis

Treatments

Drug: SYM-1219

Study type

Interventional

Funder types

Industry

Identifiers

NCT02452866

SYM-1219-350

Details and patient eligibility

About

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.

Full 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.

Enrollment

325 patients

Sex

Female

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.