Multi-Center Study of New Medications to Treat Vaginal Infections

NCT02308007 | Completed Phase 3 Results

• 1 other identifier: MTC-001 (Trial 3)
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 51

Brief Summary

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

Conditions

Vaginal Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cure of the BV Component of Mixed Infection

  7-14 days after beginning treatment

• Cure of the VVC Component of Mixed Infection

  7-14 days after beginning treatment

• Microbiologic and Mycologic Cure

  7-14 days after beginning treatment

• Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit

  7-14 days after beginning treatment

• Number of Participants With Treatment Emergent Adverse Events

  Any time during study participation (up to 30 days)

Study Arms (3)

Terconazole vaginal gel

ACTIVE COMPARATOR

One applicator full at bedtime

Drug: Terconazole

Metronidazole vaginal gel

ACTIVE COMPARATOR

One applicator full at bedtime

Drug: Metronidazole

Terconazole/metronidazole vaginal gel

ACTIVE COMPARATOR

One applicator full at bedtime

Drug: Terconazole/metronidazole

Interventions

Terconazole DRUG

Terconazole vaginal gel

Metronidazole DRUG

Metronidazole vaginal gel

Terconazole/metronidazole DRUG

Terconazole/metronidazole vaginal gel

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Curatek Pharmaceuticals, LLC: lead

Study Sites (51)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35205, United States

Location

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Precision Trials, AZ

Phoenix, Arizona, 85032, United States

Location

MomDoc Womens Health Research

Scottsdale, Arizona, 85251, United States

Location

DelSol Research

Tucson, Arizona, 85710, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

Gossmont Center for Clinical Research

La Mesa, California, 91942, United States

Location

Genesis Center for Clinical Research

San Diego, California, 92103, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Downtown Women's Health Care

Denver, Colorado, 80209, United States

Location

Red Rocks Ob/Gyn

Lakewood, Colorado, 80228, United States

Location

Women's Health CT Ob/Gyn

Bridgeport, Connecticut, 06606, United States

Location

Precision Clinical Research

Coral Springs, Florida, 33065, United States

Location

KO Clinical Research, LLC

Fort Lauderdale, Florida, 33316, United States

Location

Segal Institute for Clinical Research

North Miami, Florida, 33161, United States

Location

Discovery Clinical Research

Plantation, Florida, 33324, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Atlanta North Gynecology

Roswell, Georgia, 30075, United States

Location

Mount Vernon CLinical Research

Sandy Springs, Georgia, 30328, United States

Location

Rosemark Womens Care Specialists

Idaho Falls, Idaho, 83404, United States

Location

Women's Health Practice

Champaign, Illinois, 61802, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Praetorian Pharmaceutical Research, LLC

Marrero, Louisiana, 70072, United States

Location

Southern Clinical Research Associates

Metairie, Louisiana, 70001, United States

Location

Women Under Study

New Orleans, Louisiana, 70125, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Women's Healthcare Specialists, PC

Kalamazoo, Michigan, 49009, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Women's Clinic of Lincoln

Lincoln, Nebraska, 68510, United States

Location

Legacy Women's Health

Las Vegas, Nevada, 89123, United States

Location

R. Garn Mabey Jr., MD Gynecology

Las Vegas, Nevada, 89128, United States

Location

Lawrence Ob/Gyn Clinical Research LLC

Lawrenceville, New Jersey, 08648, United States

Location

Women's Health Research Center

Plainsboro, New Jersey, 08536, United States

Location

Suffolk OB/GYN

Port Jefferson, New York, 11777, United States

Location

East Carolina Women's Center

New Bern, North Carolina, 28562, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Radiant Research

Columbus, Ohio, 43212, United States

Location

Complete Healthcare for Women

Columbus, Ohio, 43231, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Philapelphia Clinical Research, LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Magnolia Ob/Gyn Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

James T. Martin, MD

North Charleston, South Carolina, 29406, United States

Location

The Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

Discovery Clinical Trials

Dallas, Texas, 75231, United States

Location

Signature Gyn Services

Fort Worth, Texas, 76104, United States

Location

Texas Children's Hospital for Women

Houston, Texas, 77030, United States

Location

TMC Life Research, Inc.

Houston, Texas, 77054, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Women's Clinical Research Center

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Vaginitis

Interventions

terconazole; Metronidazole

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Vice President
• Organization: Curatek Pharmaceuticals

info@curatek.com

847-806-7680

Study Officials

• Robert J Borgman, Ph.D.

  Curatek Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 4, 2014
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 4, 2020
• Results First Posted: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (51)