A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:12/16/2017
Start Date:May 2014
End Date:October 2014

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

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.


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).
We found this trial at
16
sites
830
mi
from 43215
Clearwater, FL
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492
mi
from 43215
Birmingham, AL
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163
mi
from 43215
Detroit, MI
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991
mi
from 43215
Houston, TX
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431
mi
from 43215
Jackson, TN
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LawrenceVille, New Jersey 08648
438
mi
from 43215
LawrenceVille, NJ
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468
mi
from 43215
New Bern, NC
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986
mi
from 43215
North Miami, FL
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416
mi
from 43215
Philadelphia, PA
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445
mi
from 43215
Plainsboro, NJ
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416
mi
from 43215
Roswell, GA
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246
mi
from 43215
Saginaw, MI
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1144
mi
from 43215
San Antonio, TX
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1951
mi
from 43215
San Diego, CA
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2005
mi
from 43215
Seattle, WA
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437
mi
from 43215
Virginia Beach, VA
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