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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02308033
Other study ID # MTC-001 (Trial 2)
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 204
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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metronidazole

Gel vehicle


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 Radiant Research Columbus Ohio
United States Downtown Women's Health Care Denver Colorado
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 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 Harborview Medical Center Seattle Washington
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. 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 Improvement of BV Clue Cells Clue cells on wet mount were assessed and categorized as absent (<20%) or present (>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (<20%). 7-14 days after beginning treatment
Secondary Microbiologic Improvement/Cure For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments. 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)
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