Multi-Center Study of New Medications to Treat Vaginal Infections

NCT02308033 | Completed Phase 3 Results

• 1 other identifier: MTC-001 (Trial 2)
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 35

Brief Summary

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

Conditions

Vaginal Infection

Outcome Measures

Primary Outcomes (1)

• 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. Clinical cure of bacterial vaginosis is 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 Outcomes (4)

• Improvement of BV Clue Cells

  7-14 days after beginning treatment

• Microbiologic Improvement/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 (2)

Metronidazole vaginal gel

ACTIVE COMPARATOR

One applicator full at bedtime

Drug: Metronidazole

Gel vehicle

PLACEBO COMPARATOR

One applicator full at bedtime

Drug: Gel vehicle

Interventions

Metronidazole DRUG

Metronidazole vaginal gel

Gel vehicle DRUG

Gel vehicle

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 (35)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

MomDoc Womens Health Research

Scottsdale, Arizona, 85251, 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

Segal Institute for Clinical Research

North Miami, Florida, 33161, United States

Location

Discovery Clinical Research

Plantation, Florida, 33324, 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

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

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

James T. Martin, MD

North Charleston, South Carolina, 29406, United States

Location

The Jackson Clinic

Jackson, Tennessee, 38305, 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

Metronidazole; Gels

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; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

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, 2017
• Study Completion: June 1, 2017
• Last Updated: July 27, 2020
• Results First Posted: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (35)