Multi-Center Study of New Medications to Treat Vaginal Infections
- Registration Number
- NCT02308046
- Lead Sponsor
- Curatek Pharmaceuticals, LLC
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the treatment of vaginal infections
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 212
- 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 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
Trial Locations
- Locations (41)
KO Clinical Research, LLC
🇺🇸Fort Lauderdale, Florida, United States
Women's Clinic of Lincoln
🇺🇸Lincoln, Nebraska, United States
Women's Clinical Research Center
🇺🇸Seattle, Washington, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
R. Garn Mabey Jr., MD Gynecology
🇺🇸Las Vegas, Nevada, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Genesis Center for Clinical Research
🇺🇸San Diego, California, United States
Red Rocks Ob/Gyn
🇺🇸Lakewood, Colorado, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
HWC Women's Research Center
🇺🇸Englewood, Ohio, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Women's Health CT Ob/Gyn
🇺🇸Bridgeport, Connecticut, United States
Women's Health Practice
🇺🇸Champaign, Illinois, United States
New Horizons Clinical Trials
🇺🇸Chandler, Arizona, United States
Atlanta North Gynecology
🇺🇸Roswell, Georgia, United States
Women's Healthcare Specialists, PC
🇺🇸Kalamazoo, Michigan, United States
Downtown Women's Health Care
🇺🇸Denver, Colorado, United States
Gossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
Segal Institute for Clinical Research
🇺🇸North Miami, Florida, United States
East Carolina Women's Center
🇺🇸New Bern, North Carolina, United States
Southern Clinical Research Associates
🇺🇸Metairie, Louisiana, United States
Suffolk OB/GYN
🇺🇸Port Jefferson, New York, United States
Women's Health Research Center
🇺🇸Plainsboro, New Jersey, United States
James T. Martin, MD
🇺🇸North Charleston, South Carolina, United States
Philapelphia Clinical Research, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Magee-Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
MomDoc Womens Health Research
🇺🇸Scottsdale, Arizona, United States
TMC Life Research, Inc.
🇺🇸Houston, Texas, United States
Discovery Clinical Research
🇺🇸Plantation, Florida, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Rosemark Womens Care Specialists
🇺🇸Idaho Falls, Idaho, United States
Legacy Women's Health
🇺🇸Las Vegas, Nevada, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Lawrence Ob/Gyn Clinical Research LLC
🇺🇸Lawrenceville, New Jersey, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Discovery Clinical Trials
🇺🇸Dallas, Texas, United States
Multicare Women's Center Covington
🇺🇸Covington, Washington, United States
Mount Vernon CLinical Research
🇺🇸Sandy Springs, Georgia, United States
Praetorian Pharmaceutical Research, LLC
🇺🇸Marrero, Louisiana, United States
Radiant Research
🇺🇸Columbus, Ohio, United States