A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:12 - Any
Updated:4/21/2016
Start Date:May 2015
End Date:December 2015

Use our guide to learn which trials are right for you!

A Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of SYM-1219 2 Grams for the Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis

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.


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)
We found this trial at
21
sites
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
804
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
1959
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
1293
mi
from 91732
Corpus Christi, TX
Click here to add this to my saved trials
817
mi
from 91732
Denver, CO
Click here to add this to my saved trials
1840
mi
from 91732
Grand Rapids, MI
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
1546
mi
from 91732
Jonesboro, AR
Click here to add this to my saved trials
2149
mi
from 91732
Leesburg, FL
Click here to add this to my saved trials
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
2234
mi
from 91732
Myrtle Beach, SC
Click here to add this to my saved trials
2314
mi
from 91732
New Bern, NC
Click here to add this to my saved trials
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
2403
mi
from 91732
Plainsboro, NJ
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
964
mi
from 91732
Seattle, WA
Click here to add this to my saved trials
2350
mi
from 91732
Virginia Beach, VA
Click here to add this to my saved trials
2294
mi
from 91732
Wellington, FL
Click here to add this to my saved trials