Vaginal Infection Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1443

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
      • Agra, India, 282001
        • Chopra Nursing and Maternity Home
      • Ghaziabad, India, 201001
        • Yashoda Super Speciality Hospital
      • Hyderabad, India, 500002
        • Government Maternity Hospital
      • Hyderabad, India, 500095
        • Government Maternity Hospital
      • Lucknow, India, 226991
        • Makker Medical Center
      • New Delhi, India, 110027
        • M.K.W. Hospital and Research Centre
      • Tamil Nadu, India, 600116
        • Sri Ramachandra Medical College
    • Gujarat
      • Ahmedabad, Gujarat, India, 380016
        • Institute of Kidney Disease and Research Centre
      • Vadodara, Gujarat, India, 390006
        • Krishna Hospital Surgical & Maternity 201/2/3 Suryadeep Complex
    • Kamataka
      • Mangalore, Kamataka, India, 575002
        • Father Muller Medical College Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560064
        • Neha Prakash Hospital
      • Mangalore, Karnataka, India, 575001
        • KMC Hospital
      • Mangalore, Karnataka, India, 575018
        • Yenepoya Medical College and Hospital
    • Maharashtra
      • Nagpur, Maharashtra, India, 440010
        • Om Women's Hospital
      • Nagpur, Maharashtra, India, 440012
        • Avanti Institute of Cardiology
      • Nagpur, Maharashtra, India, 440022
        • Nagpur Test Tube Baby Centre
      • Nashik, Maharashtra, India, 422001
        • VSG Healthcare, Dr. Ganorkar Hospital
      • Nashik, Maharashtra, India, 422002
        • Nivedita Hospital
      • Pune, Maharashtra, India, 411011
        • KEM Hospital Research Centre
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital and Research Centre
      • Pune, Maharashtra, India
        • Dr. D. Y. Patil Medical College & Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600116
        • Sri Ramachandra Medical College
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Ponce School of Medicine
  • Russian Federation
      • Kaluga, Russian Federation, 24800
        • Kaluga Regional Dermatovenerologic Dispensary
      • Moscow, Russian Federation, 119415
        • City Clinical Hospital #31
      • Moscow, Russian Federation, 101000
        • Moscow Regional Research Insitute of Obstetrics and Gynecology
      • Moscow, Russian Federation, 111538
        • Dermatovenerologic Dispensary #15
      • Moscow, Russian Federation, 117152
        • Family Planning and Reproductive Centre
      • Moscow, Russian Federation, 117198
        • The Peoples' Friendship University of Russia
      • Moscow, Russian Federation, 117997
        • City Clinical Hospital #52
      • Moscow, Russian Federation, 119435
        • Clinic of Skin and Sexual Transmitted Diseases
      • Moscow, Russian Federation, 121309
        • City Clinical Hospital #51
      • Nizhny Novgorod, Russian Federation, 603950
        • Nizhegorodskiy Dermatovenerologic Scientific Research Institute of Federal Agency for Public Health and Human Services
      • Rostov-on-Don, Russian Federation, 344007
        • Regional dermatovenerologic dispensary
      • Ryazan, Russian Federation, 390046
        • Ryazan regional clinical dermatovenerologic dispensary
      • Saint Petersburg, Russian Federation, 190020
        • Juventa--Reproductive Health
      • Saint Petersburg, Russian Federation, 191124
        • 442 District Military Clinical Hospital of Leningradsky Military District
      • Saint Petersburg, Russian Federation, 192102
        • City Dermatovenerologic Dispensary
      • Saint Petersburg, Russian Federation, 194044
        • S.M. Kirov Military Medical Academy, MoD of the Russian Federation
      • Saint Petersburg, Russian Federation, 194291
        • L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#321
      • Saint Petersburg, Russian Federation, 194291
        • L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#322
      • Saint Petersburg, Russian Federation, 194291
        • Leningradskiy Regional Clinical Hospital
      • Saint Petersburg, Russian Federation, 195008
        • Family Planning and Reproductive Centre
      • Saint Petersburg, Russian Federation, 195067
        • St. Petersburg State I.I. Mechnikov Medical Academy of Roszdrav
      • Saint Petersburg, Russian Federation, 197136
        • Andros Clinic, LLC
      • Smolensk, Russian Federation, 214000
        • Smolensk Dermatovenerologic Dispensary
      • St. Petersburg, Russian Federation, 191015
        • Medical Mycology Scientific Research Institute at St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav
    • Moscow Region
      • Korolev, Moscow Region, Russian Federation, 141074
        • Dermatovenerologic Dispensary
    • Saint Petersburg
      • Mendeleevskaya line, Saint Petersburg, Russian Federation, 199034
        • D.O. Ott Research Institute of Ob/Gyn--Family Planning and Female Health Center
      • Mendeleyevskaya, Saint Petersburg, Russian Federation, 199034
        • D.O. Ott Research Institute of Ob/Gyn--Gynecologic Endocrinology
      • V.o., Saint Petersburg, Russian Federation, 199178
        • Orkli, LLC
    • Smolensk Region
      • Smolensk, Smolensk Region, Russian Federation, 214019
        • Smolensk State Medical Academy of RosZdrav
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Clinical Research Consultants, Inc
      • Birmingham, Alabama, United States, 35233
        • Jefferson Clinic, PC
      • Enterprise, Alabama, United States, 36330
        • Choice Research, LLC
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Star W. Research
      • Glendale, Arizona, United States, 85304
        • Precision Trials, LLC/Desert West OB/GYN
      • Phoenix, Arizona, United States, 85015
        • Women's Health Research
      • Phoenix, Arizona, United States, 85032
        • Precision Trials LLC
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research - Tucson
    • Arkansas
      • Jonesboro, Arkansas, United States, 33760
        • NEA Women's Clinic
      • Little Rock, Arkansas, United States, 72204
        • Arkansas Primary Care Clinic, PA
      • Little Rock, Arkansas, United States, 72205
        • The Woman's Clinic, P.A.
      • Searcy, Arkansas, United States, 72143
        • Precision Clinical Research
    • California
      • Carmichael, California, United States, 95608
        • Med Center
      • Dinuba, California, United States, 93618
        • Universal Biopharma Research Institute, Inc./Alta Family Health Clinic, Inc.
      • Fresno, California, United States, 93611
        • Sierra Medical Research
      • La Mesa, California, United States, 91942
        • Grossmont Center for Clinical Research
      • San Diego, California, United States, 92103
        • San Diego Clinical Research Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Lynn Institute Of The Rockies
      • Lakewood, Colorado, United States, 80228
        • Red Rocks OB/Gyn
      • Pueblo, Colorado, United States, 81001
        • Lynn Institute of Pueblo
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Women's Health Care Associates, PC
      • West Hartford, Connecticut, United States, 06117
        • Greater Hartford Womens Association/Women's Health
    • Florida
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group, LLC
      • North Miami, Florida, United States, 33161
        • Segal Institute for Clinical Research
      • Sarasota, Florida, United States, 34239
        • Physician Care Clinical Research
      • Tampa, Florida, United States, 33607
        • Insignia Clinical Research
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Atlanta Medical Research Institute
      • Bogart, Georgia, United States, 30622
        • AMR Research Associates
      • Decatur, Georgia, United States, 30034
        • Soapstone Center for Clinical Research
      • Decatur, Georgia, United States, 30033
        • Medical Network for Educators and Research
      • Douglasville, Georgia, United States, 30134
        • Atlanta West Women's Center
    • Idaho
      • Boise, Idaho, United States, 83712
        • The Woman's Clinic
      • Idaho Falls, Idaho, United States, 83404
        • Rosemark Women Care Specialists
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Womans Health Practice, LLC
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Womens Health Research
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • Clinical Trials Management
      • Shreveport, Louisiana, United States, 71106
        • Regional Research Specialists, LLC
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • New England Center for Clinical Research, Inc.
      • Haverhill, Massachusetts, United States, 01830
        • ActivMed Practices & Research, Inc.
      • New Bedford, Massachusetts, United States, 02740
        • Healthcare for Women
    • Michigan
      • Grand Rapids, Michigan, United States, 49506
        • Female Pelvic Medicine and Urogynecology Institute of Michigan
      • Paw Paw, Michigan, United States, 49079
        • Women's Health Care Specialists, PC
    • Missouri
      • St. Louis, Missouri, United States, 63117
        • Women's Health Partner
      • St. Louis, Missouri, United States, 63131
        • Consultants in Women's Healthcare
      • St. Louis, Missouri, United States, 63141
        • New Ballas OB-GYN, Inc.
    • Nevada
      • Reno, Nevada, United States, 89502
        • The Medical Group of Northern Nevada
    • New York
      • Port Jefferson, New York, United States, 11777
        • Suffolk OB/GYN
      • Woodbury, New York, United States, 11797
        • Preferred OB/GYN/ Women's Health
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Eastowne OB-GYN and Infertility
      • New Bern, North Carolina, United States, 28562
        • Eastern Carolina Women's Center
      • Winston-Salem, North Carolina, United States, 27103
        • Hawthorne Medical Research, Inc.
      • Winston-Salem, North Carolina, United States, 27103
        • Valaores & Lewis Obstetrics & Gynocology
    • North Dakota
      • Bismark, North Dakota, United States, 58501
        • Mid Dakota Clinic Center for Women
    • Ohio
      • Columbus, Ohio, United States, 43231
        • Complete Healthcare For Women
      • Englewood, Ohio, United States, 45322
        • HWC Women's Research Center
      • Gallipolis, Ohio, United States, 45631
        • Holzer Clinic
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pacific Women's Center, LLC
      • Medford, Oregon, United States, 97504
        • Medford Women's Clinic, LLP
    • Pennsylvania
      • Hopwood, Pennsylvania, United States, 15445
        • Laurel Highlands Ob/Gyn, PC
      • Natrona Heights, Pennsylvania, United States, 15065
        • Clinical Trials Research Services, LLC
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Associates Ob/Gyn
      • Memphis, Tennessee, United States, 38119
        • Women's Care Center, PLC
    • Texas
      • Austin, Texas, United States, 78705
        • Women Partners in Health
      • Corpus Christi, Texas, United States, 78414
        • Advanced Research Associates
      • El Paso, Texas, United States, 79902
        • Research Across America
      • Houston, Texas, United States, 77054
        • The Woman's Hospital of Texas Clinical Research Center
      • Houston, Texas, United States, 77054
        • TMC Life Research, Inc
      • Houston, Texas, United States, 77004
        • Planned Parenthood of Houston
      • Irving, Texas, United States, 75061
        • Bexar Clinical Trials, LLC
      • Plano, Texas, United States, 75093
        • Willowbend Health and Wellness
      • San Antonio, Texas, United States, 78217
        • InVisions Consultants, LLC c/o Northeast Ob/Gyn
      • Temple, Texas, United States, 76502
        • King's Daughter Clinic
    • Utah
      • Layton, Utah, United States, 84041
        • Tanner Clinic
      • Pleasant Grove, Utah, United States, 84062
        • Mt. Timpangos Women's Healthcare
      • Salt Lake City, Utah, United States, 84107
        • Salt Lake Research
      • Sandy, Utah, United States, 84070
        • Salt Lake Women's Center
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Tidewater Clinical Research, Inc
    • Washington
      • Walla Walla, Washington, United States, 99362
        • Walla Walla Clinic
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Hyperion Clinical Research, LLC
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Aurora Advanced Healthcare, Inc

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

14 years and older (Child, Adult, Older Adult)

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 Assignment
  • 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
clindamycin phosphate
Drug: clindamycin phosphate
semi solid, single dose
Active Comparator: 3
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
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
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

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

January 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 15, 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-302-602-622467

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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