The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole gel in the treatment of vaginal infections
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
475
Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit
The percentage of participants with clinical cure of both bacterial vaginosis (BV) AND vulvovaginal candidiasis (VVC) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV is defined as: discharge has returned to normal/physiologic, negative whiff test, and saline wet mount is \<20% clue cells. Clinical cure of VVC is defined as resolution of all signs and symptoms attributable to vulvovaginal candidiasis
Time frame: 7-14 days after beginning treatment
Cure of the BV Component of Mixed Infection
The percentage of participants with both BV and VVC who had clinical cure of bacterial vaginosis (BV) was compared between the combination therapy and the two single entity treatments. Clinical cure of BV was 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
Time frame: 7-14 days after beginning treatment
Cure of the VVC Component of Mixed Infection
The percentage of participants with both BV and VVC who had clinical cure of VVC was compared between the combination therapy and the two single entity treatments.Clinical cure of VVC was defined as complete resolution of all signs and symptoms attributable to VVC
Time frame: 7-14 days after beginning treatment
Microbiologic and Mycologic Cure
The percentage of participants with both microbiologic and mycologic cure was compared between the combination therapy and the two single entity treatments. Yeast cultures were performed and Gram stains of vaginal fluid were graded according to Nugent's criteria. Microbiologic cure requires normal Nugent gram stain score and mycologic cure requires negative yeast culture.
Time frame: 7-14 days after beginning treatment
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Alabama Clinical Therapeutics
Birmingham, Alabama, United States
University of Alabama
Birmingham, Alabama, United States
Precision Trials, AZ
Phoenix, Arizona, United States
MomDoc Womens Health Research
Scottsdale, Arizona, United States
DelSol Research
Tucson, 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
...and 41 more locations
Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit
Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.
Time frame: 7-14 days after beginning treatment
Number of Participants With Treatment Emergent Adverse Events
Adverse events were collected at study visits, from subject diaries and from spontaneous reports
Time frame: Any time during study participation (up to 30 days)