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 terconazole 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
Terconazole vaginal gel	Terconazole	One applicator full at bedtime
Gel vehicle	Placebo	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. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis

Secondary Outcome Measures

Name	Time	Method
Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection	7-14 days after beginning treatment	Signs (edema, erythema, excoriation) and symptoms (itching, burning irritation) were each scored as absent (0), mild (1), moderate (2) or severe (3). A total sign score of 0-9 and total symptom score of 0-9 were combined for a total possible combined sign and symptom score of 0-18. Total median combined sign and symptom severity score was compared between arms at the test of cure visit. Lower scores at day 7-14 indicate improvement.
Mycologic Cure	7-14 days after beginning treatment and at 21-30 days after beginning treatment	Vaginal swabs were cultured for Candida species in a laboratory. A positive culture indicates presence of vaginal yeast and a negative culture indicates absence of vaginal yeast. A negative culture indicates mycologic cure.
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.
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

Locations (41): University of Alabama
🇺🇸
Birmingham, Alabama, United States
New Horizons Clinical Trials
🇺🇸
Chandler, Arizona, 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
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University of Alabama
🇺🇸Birmingham, Alabama, United States