Multi-Center Study of New Medications to Treat Vaginal Infections

Vaginal Infection Clinical Trial

— SMART GIVES  

Official title:

Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308046
• Other study ID #: MTC-001 (Trial 1)
• Status: Completed
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2020
• Source: Curatek Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the treatment of vaginal infections

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

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

Related Conditions & MeSH terms

• Infection
• Vaginal Infection

Intervention

Drug:
• Terconazole

• Placebo

Locations

Country	Name	City	State
United States	Georgia Regents University	Augusta	Georgia
United States	University of Alabama	Birmingham	Alabama
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	Radiant Research	Columbus	Ohio
United States	Multicare Women's Center Covington	Covington	Washington
United States	Discovery Clinical Trials	Dallas	Texas
United States	Downtown Women's Health Care	Denver	Colorado
United States	HWC Women's Research Center	Englewood	Ohio
United States	KO Clinical Research, LLC	Fort Lauderdale	Florida
United States	TMC Life Research, Inc.	Houston	Texas
United States	Rosemark Womens Care Specialists	Idaho Falls	Idaho
United States	The Jackson Clinic	Jackson	Tennessee
United States	NEA Baptist Clinic	Jonesboro	Arkansas
United States	Women's Healthcare Specialists, PC	Kalamazoo	Michigan
United States	Gossmont Center for Clinical Research	La Mesa	California
United States	Red Rocks Ob/Gyn	Lakewood	Colorado
United States	Legacy Women's Health	Las Vegas	Nevada
United States	R. Garn Mabey Jr., MD Gynecology	Las Vegas	Nevada
United States	Lawrence Ob/Gyn Clinical Research LLC	Lawrenceville	New Jersey
United States	Women's Clinic of Lincoln	Lincoln	Nebraska
United States	Praetorian Pharmaceutical Research, LLC	Marrero	Louisiana
United States	Southern Clinical Research Associates	Metairie	Louisiana
United States	East Carolina Women's Center	New Bern	North Carolina
United States	James T. Martin, MD	North Charleston	South Carolina
United States	Segal Institute for Clinical Research	North Miami	Florida
United States	Drexel University	Philadelphia	Pennsylvania
United States	Philapelphia Clinical Research, LLC	Philadelphia	Pennsylvania
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Women's Health Research Center	Plainsboro	New Jersey
United States	Discovery Clinical Research	Plantation	Florida
United States	Suffolk OB/GYN	Port Jefferson	New York
United States	Wake Research Associates	Raleigh	North Carolina
United States	Atlanta North Gynecology	Roswell	Georgia
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Genesis Center for Clinical Research	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California
United States	Mount Vernon CLinical Research	Sandy Springs	Georgia
United States	MomDoc Womens Health Research	Scottsdale	Arizona
United States	Women's Clinical Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Curatek Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit	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	7-14 days after beginning treatment
Secondary	Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection	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.	7-14 days after beginning treatment
Secondary	Mycologic Cure	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.	7-14 days after beginning treatment and at 21-30 days after beginning treatment
Secondary	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.	7-14 days after beginning treatment
Secondary	Number of Participants With Treatment Emergent Adverse Events	Adverse events were collected at study visits, from subject diaries and from spontaneous reports	Any time during study participation (up to 30 days)