Vaginal Infection Study 2

February 29, 2012 updated by: Lumara Health, Inc.
This study will evaluate the efficacy and safety of a vaginal product compared with that of another vaginal product in the treatment of vaginal infections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

843

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Hyderabad, India, 500034
        • Care hospital
      • Jaipur, India, 302001
        • Shri Krishna Hospital
      • Ranga Reddy District, India, 501401
        • Mediciti Institute of Medical Sciences
      • Secunderabad, India, 500003
        • Krishna Institute of medical sciences
      • Visakhapatnam, India, 530002
        • King George Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560043
        • Bangalore Diabetes Centre
      • Mangalore, Karnataka, India, 575004
        • AJ Medical College and Hospital
    • Rajasthan
      • Ajmer, Rajasthan, India, 305001
        • Mayani Hosptial and Research Centre
      • Jaipur, Rajasthan, India, 302020
        • Sharda Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • MV Hospital and Research Centre
  • Russian Federation
      • Kazan, Russian Federation, 420012
        • Medical University Clinic
      • Krasnodar, Russian Federation, 350020
        • Clinical Dermatovenerologic Dispensary
      • Moscow, Russian Federation, 107076
        • State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid
      • Moscow, Russian Federation, 115516
        • State Health Care Institution Moscow City Clinical Hospital #12
      • Moscow, Russian Federation, 123995
        • Russian Medical Academy of Postgraduate Studies of Roszdrav
      • Moscow, Russian Federation, 127473
        • State Healthcare Institution Moscow Clinical Hospital #68
      • Novosibirsk, Russian Federation, 630082
        • Novisibirsk Municipal Dermatovenerologic Dispensary #1
      • Orenburg, Russian Federation, 460000
        • State Health Care Institution Orenburg Regional Clinical Hospital #2
      • Petrozavodsk, Russian Federation, 185002
        • Republican Dermatovenerologic Dispensary, MoH of Karelia Republic
      • Saint Petersburg, Russian Federation, 196084
        • Medical Research Institute, LLC
      • Saint Petersburg, Russian Federation, 196247
        • City Hospital #26
      • Saint Petersburg, Russian Federation, 194044
        • S.M. Kirov Military Medical Academy, MoD of the Russian Federation
      • Saint Petersburg, Russian Federation, 190000
        • Maximillian City Hospital #28
      • Saint Petersburg, Russian Federation, 190020
        • State Healthcare Institution Regional Dermatovenerologic Dispensary
      • Saint Petersburg, Russian Federation, 194354
        • City Multifield Hospital
      • Saint Petersburg, Russian Federation, 197022
        • St. Petersburg I.P. Pavlov State Medical University of Roszdrav
      • Voronezh, Russian Federation, 394024
        • Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC
      • Voronezh, Russian Federation, 394038
        • Voronezh Regional Clinical Dermatovenerologic Dispensary
      • Yaroslavl, Russian Federation, 150003
        • Yaroslavl Regional Maternity Hospital
    • Saint Petersburg
      • Sestroretsk, Saint Petersburg, Russian Federation, 197706
        • Kurortniy Ward City Hospital #40
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Brookwood Ob-GYN, PC/Women's Medical Plaza
      • Montgomery, Alabama, United States, 36106
        • Drug Research Analysis Corp
      • Montgomery, Alabama, United States, 36106
        • Drug Research and Analysis Corp.
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • OB/Gyn Associates
      • Little Rock, Arkansas, United States, 72205
        • The Woman's Clinic, PA
    • California
      • Los Angeles, California, United States, 90025
        • Peak Health Medical Group
      • San Diego, California, United States, 30035
        • Women's Health Care at Frost Street
      • West Hills, California, United States, 91307
        • Steven Freedman, MD, Inc.
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Red Rocks OB/Gyn
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • SHE Medical Center
    • Florida
      • Largo, Florida, United States, 33774
        • Debra Hemsath, MD
      • Miami, Florida, United States, 33156
        • International Research Associates
      • Palm Harbor, Florida, United States, 34684
        • Suncoast Clinical Research
      • Pines, Florida, United States, 33024
        • University Clinical Research
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Total Women's Health and Wellness
      • Decatur, Georgia, United States, 30035
        • Dekalb Gynecology Associates
      • Riverdale, Georgia, United States, 30274
        • New Millennium OB/GYN
    • Idaho
      • Boise, Idaho, United States, 83712
        • The Woman's Clinic
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic Department of Ob/Gyn
    • Maryland
      • Bel Air, Maryland, United States, 21014
        • Steven Z. Lenowitz, MD, LLC
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrence OB/GYN Associates
      • Lawrenceville, New Jersey, United States, 08648
        • Women's Health Research Center, LLC
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Triangle Ob/Gyn
      • Fayetteville, North Carolina, United States, 28304
        • Women's Wellness Center
      • Greensboro, North Carolina, United States, 27455
        • Meridian Clinical Research, LLC
    • Ohio
      • Gallipolis, Ohio, United States, 45631
        • Holzer Clinic
      • Wadsworth, Ohio, United States, 44281
        • Family Practice Center of Wadsworth, Inc
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Lynn Institute of Norman
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pacific Women's Center, LLC/Clinical Trials of America
    • Pennsylvania
      • Lansdale, Pennsylvania, United States, 19446
        • Center for Women's Health of Lansdale
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Creekside Women's Care
      • Clinton, South Carolina, United States, 29325
        • The Family Healthcare Center, PA
      • Greenville, South Carolina, United States, 29615
        • Greenville Pharmaceutical Research
      • North Charleston, South Carolina, United States, 29406
        • James T. Martin, Jr., MD, Ob/Gyn
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Brown Clinical, PLLP
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Gynecology and Obstetrics
      • Memphis, Tennessee, United States, 38120
        • Mid-South Ob/Gyn
    • Texas
      • Euless, Texas, United States, 76039
        • Kaner Medical Group, PA
      • McAllen, Texas, United States, 78505
        • Advanced Reserch Associates
      • Plano, Texas, United States, 75093
        • Willowbend Health & Wellness
    • Utah
      • Bountiful, Utah, United States, 84010
        • Taylor/Wade Medical
    • Vermont
      • Williston, Vermont, United States, 05495
        • Vermont Urogynecology Associates, PC
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Tidewater Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients must have a clinical diagnosis of vaginal infection.
  • Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.

Exclusion Criteria:

  • Patients must not have any other infections
  • May not be pregnant or nursing
  • May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
clindamycin phosphate/butoconazole nitrate
Drug: clindamycin phosphate/butoconazole nitrate
semi-solid, single dose
ACTIVE_COMPARATOR: 2
butoconazole nitrate
Drug: butoconazole nitrate
semi-solid, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical symptom resolution
Time Frame: baseline, 7 to 10 days and 21 to 30 days
baseline, 7 to 10 days and 21 to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yeast Culture for Candida
Time Frame: baseline, 7 to 10 days and 21 to 30 days
Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response
baseline, 7 to 10 days and 21 to 30 days
Saline wet mount for clue cells
Time Frame: baseline, 7 to 10 days and 21 to 30 days
Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution
baseline, 7 to 10 days and 21 to 30 days
Gram Stain Nugent Score
Time Frame: baseline, 7 to 10 days and 21 to 30 days
Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution
baseline, 7 to 10 days and 21 to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumara Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

June 9, 2008

First Submitted That Met QC Criteria

June 10, 2008

First Posted (ESTIMATE)

June 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2012

Last Update Submitted That Met QC Criteria

February 29, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBC-303-603-622467

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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