Status:
COMPLETED
Multi-Center Study of New Medications to Treat Vaginal Infections
Lead Sponsor:
Curatek Pharmaceuticals, LLC
Conditions:
Vaginal Infection
Eligibility:
FEMALE
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.
Eligibility Criteria
Inclusion
- A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:
- Capable of providing written informed consent or assent
- Currently not menstruating and not anticipating menses during treatment
- If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control
- Negative pregnancy test
- Other criteria as identified in the protocol
Exclusion
- Other infectious causes of vulvovaginitis
- Subject has recently used, or is expected to require the concomitant use of prohibited medications/products
- Nursing mother
- Use of any investigational drug within 30 days of enrollment
- History of hypersensitivity to any ingredient/component of the formulations
- Other criteria as identified in the protocol
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT02308033
Start Date
June 1 2015
End Date
June 1 2017
Last Update
July 27 2020
Active Locations (35)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
MomDoc Womens Health Research
Scottsdale, Arizona, United States, 85251
3
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
4
Gossmont Center for Clinical Research
La Mesa, California, United States, 91942