Multi-Center Study of New Medications to Treat Vaginal Infections
- Conditions
- Vaginal Infection
- Interventions
- Registration Number
- NCT02308007
- Lead Sponsor
- Curatek Pharmaceuticals, LLC
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of terconazole/metronidazole gel in the treatment of vaginal infections
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 475
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metronidazole vaginal gel Metronidazole One applicator full at bedtime Terconazole/metronidazole vaginal gel Terconazole/metronidazole One applicator full at bedtime Terconazole vaginal gel Terconazole One applicator full at bedtime
- Primary Outcome Measures
Name Time Method Clinical Cure of Mixed Infection (BV and VVC) as Assessed by the Investigator at the Test-of-cure Visit 7-14 days after beginning treatment 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
- Secondary Outcome Measures
Name Time Method Cure of the VVC Component of Mixed Infection 7-14 days after beginning treatment 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
Microbiologic and Mycologic Cure 7-14 days after beginning treatment 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.
Cure of the BV Component of Mixed Infection 7-14 days after beginning treatment 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
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
Trial Locations
- Locations (51)
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
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