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: NCT02308007
• Other study ID #: MTC-001 (Trial 3)
• Status: Completed
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: June 2018

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/metronidazole gel in the treatment of vaginal infections

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• 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

• Metronidazole

• Terconazole/metronidazole

Locations

Country	Name	City	State
United States	Georgia Regents University	Augusta	Georgia
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
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	Complete Healthcare for Women	Columbus	Ohio
United States	Radiant Research	Columbus	Ohio
United States	Precision Clinical Research	Coral Springs	Florida
United States	Discovery Clinical Trials	Dallas	Texas
United States	Downtown Women's Health Care	Denver	Colorado
United States	Wayne State University	Detroit	Michigan
United States	KO Clinical Research, LLC	Fort Lauderdale	Florida
United States	Signature Gyn Services	Fort Worth	Texas
United States	Texas Children's Hospital for Women	Houston	Texas
United States	TMC Life Research, Inc.	Houston	Texas
United States	Rosemark Womens Care Specialists	Idaho Falls	Idaho
United States	Indiana University	Indianapolis	Indiana
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	Magnolia Ob/Gyn Research Center	Myrtle Beach	South Carolina
United States	East Carolina Women's Center	New Bern	North Carolina
United States	Women Under Study	New Orleans	Louisiana
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	Precision Trials, AZ	Phoenix	Arizona
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	Harborview Medical Center	Seattle	Washington
United States	Women's Clinical Research Center	Seattle	Washington
United States	DelSol Research	Tucson	Arizona
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida

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 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	7-14 days after beginning treatment
Secondary	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	7-14 days after beginning treatment
Secondary	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	7-14 days after beginning treatment
Secondary	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.	7-14 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)