Multi-Center Study of New Medications to Treat Vaginal Infections

Phase 3

Completed

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Metronidazole vaginal gel	Metronidazole	One applicator full at bedtime
Gel vehicle	Gel vehicle	One applicator full at bedtime

Primary Outcome Measures

Name	Time	Method
Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit	7-14 days after beginning treatment	The percentage of participants with clinical cure in each arm was compared. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is \<20% clue cells

Secondary Outcome Measures

Name	Time	Method
Improvement of BV Clue Cells	7-14 days after beginning treatment	Clue cells on wet mount were assessed and categorized as absent (\<20%) or present (\>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (\<20%).
Microbiologic Improvement/Cure	7-14 days after beginning treatment	For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments.
Number of Participants With Treatment Emergent Adverse Events	Any time during study participation (up to 30 days)	Adverse events were collected at study visits, from subject diaries and from spontaneous reports
Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit	7-14 days after beginning treatment	Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.

Locations (35): University of Alabama
🇺🇸
Birmingham, Alabama, United States
MomDoc Womens Health Research
🇺🇸
Scottsdale, Arizona, United States
NEA Baptist Clinic
🇺🇸
Jonesboro, Arkansas, United States
Gossmont Center for Clinical Research
🇺🇸
La Mesa, California, United States
Genesis Center for Clinical Research
🇺🇸
San Diego, California, United States
Medical Center for Clinical Research
🇺🇸
San Diego, California, United States
Downtown Women's Health Care
🇺🇸
Denver, Colorado, United States
Red Rocks Ob/Gyn
🇺🇸
Lakewood, Colorado, United States
Women's Health CT Ob/Gyn
🇺🇸
Bridgeport, Connecticut, United States
Segal Institute for Clinical Research
🇺🇸
North Miami, Florida, United States
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University of Alabama
🇺🇸Birmingham, Alabama, United States