Vaginal Infection Study

NCT ID: NCT00616330

Last Updated: 2012-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1443 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vulvovaginitis Vaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

clindamycin phosphate/butoconazole nitrate

Group Type EXPERIMENTAL

clindamycin phosphate/butoconazole nitrate

Intervention Type DRUG

semi solid, single dose

2

clindamycin phosphate

Group Type ACTIVE_COMPARATOR

clindamycin phosphate

Intervention Type DRUG

semi solid, single dose

3

butoconazole nitrate

Group Type ACTIVE_COMPARATOR

butoconazole nitrate

Intervention Type DRUG

semi solid, single dose

Interventions

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clindamycin phosphate/butoconazole nitrate

semi solid, single dose

Intervention Type DRUG

clindamycin phosphate

semi solid, single dose

Intervention Type DRUG

butoconazole nitrate

semi solid, single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lumara Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jim Joffrion

Role: STUDY_DIRECTOR

Lumara Health, Inc.

Locations

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Bexar Clinical Trials, LLC

Irving, Texas, United States

Site Status

Clinical Research Consultants, Inc

Birmingham, Alabama, United States

Site Status

Jefferson Clinic, PC

Birmingham, Alabama, United States

Site Status

Choice Research, LLC

Enterprise, Alabama, United States

Site Status

Star W. Research

Chandler, Arizona, United States

Site Status

Precision Trials, LLC/Desert West OB/GYN

Glendale, Arizona, United States

Site Status

Women's Health Research

Phoenix, Arizona, United States

Site Status

Precision Trials LLC

Phoenix, Arizona, United States

Site Status

Visions Clinical Research - Tucson

Tucson, Arizona, United States

Site Status

NEA Women's Clinic

Jonesboro, Arkansas, United States

Site Status

Arkansas Primary Care Clinic, PA

Little Rock, Arkansas, United States

Site Status

The Woman's Clinic, P.A.

Little Rock, Arkansas, United States

Site Status

Precision Clinical Research

Searcy, Arkansas, United States

Site Status

Med Center

Carmichael, California, United States

Site Status

Universal Biopharma Research Institute, Inc./Alta Family Health Clinic, Inc.

Dinuba, California, United States

Site Status

Sierra Medical Research

Fresno, California, United States

Site Status

Grossmont Center for Clinical Research

La Mesa, California, United States

Site Status

San Diego Clinical Research Center

San Diego, California, United States

Site Status

Lynn Institute of the Rockies

Colorado Springs, Colorado, United States

Site Status

Red Rocks OB/GYN

Lakewood, Colorado, United States

Site Status

Lynn Institute of Pueblo

Pueblo, Colorado, United States

Site Status

Women's Health Care Associates, PC

Hartford, Connecticut, United States

Site Status

Greater Hartford Womens Association/Women's Health

West Hartford, Connecticut, United States

Site Status

Women's Medical Research Group, LLC

Clearwater, Florida, United States

Site Status

Segal Institute for Clinical Research

North Miami, Florida, United States

Site Status

Physician Care Clinical Research

Sarasota, Florida, United States

Site Status

Insignia Clinical Research

Tampa, Florida, United States

Site Status

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, United States

Site Status

Atlanta Medical Research Institute

Alpharetta, Georgia, United States

Site Status

AMR Research Associates

Bogart, Georgia, United States

Site Status

Medical Network for Educators and Research

Decatur, Georgia, United States

Site Status

Soapstone Center for Clinical Research

Decatur, Georgia, United States

Site Status

Atlanta West Women's Center

Douglasville, Georgia, United States

Site Status

The Woman's Clinic

Boise, Idaho, United States

Site Status

Rosemark Women Care Specialists

Idaho Falls, Idaho, United States

Site Status

Womans Health Practice, LLC

Champaign, Illinois, United States

Site Status

Northern Indiana Womens Health Research

South Bend, Indiana, United States

Site Status

Clinical Trials Management

Mandeville, Louisiana, United States

Site Status

Regional Research Specialists, LLC

Shreveport, Louisiana, United States

Site Status

New England Center for Clinical Research, Inc.

Fall River, Massachusetts, United States

Site Status

Activmed Practices & Research, Inc.

Haverhill, Massachusetts, United States

Site Status

Healthcare for Women

New Bedford, Massachusetts, United States

Site Status

Female Pelvic Medicine and Urogynecology Institute of Michigan

Grand Rapids, Michigan, United States

Site Status

Women's Health Care Specialists, PC

Paw Paw, Michigan, United States

Site Status

Women's Health Partner

St Louis, Missouri, United States

Site Status

Consultants in Women's Healthcare

St Louis, Missouri, United States

Site Status

New Ballas OB-GYN, Inc.

St Louis, Missouri, United States

Site Status

The Medical Group of Northern Nevada

Reno, Nevada, United States

Site Status

Suffolk Ob/Gyn

Port Jefferson, New York, United States

Site Status

Preferred OB/GYN/ Women's Health

Woodbury, New York, United States

Site Status

Eastowne OB-GYN and Infertility

Chapel Hill, North Carolina, United States

Site Status

Eastern Carolina Women's Center

New Bern, North Carolina, United States

Site Status

Hawthorne Medical Research, Inc.

Winston-Salem, North Carolina, United States

Site Status

Valaores & Lewis Obstetrics & Gynocology

Winston-Salem, North Carolina, United States

Site Status

Mid Dakota Clinic Center for Women

Bismarck, North Dakota, United States

Site Status

Complete Healthcare for Women

Columbus, Ohio, United States

Site Status

HWC Women's Research Center

Englewood, Ohio, United States

Site Status

Holzer Clinic

Gallipolis, Ohio, United States

Site Status

Pacific Women's Center, LLC

Eugene, Oregon, United States

Site Status

Medford Women's Clinic, LLP

Medford, Oregon, United States

Site Status

Laurel Highlands Ob/Gyn, PC

Hopwood, Pennsylvania, United States

Site Status

Clinical Trials Research Services, LLC

Natrona Heights, Pennsylvania, United States

Site Status

Associates Ob/Gyn

Germantown, Tennessee, United States

Site Status

Women's Care Center, PLC

Memphis, Tennessee, United States

Site Status

Women Partners in Health

Austin, Texas, United States

Site Status

Advanced Research Associates

Corpus Christi, Texas, United States

Site Status

Research Across America

El Paso, Texas, United States

Site Status

Planned Parenthood of Houston

Houston, Texas, United States

Site Status

The Woman's Hospital of Texas Clinical Research Center

Houston, Texas, United States

Site Status

TMC Life Research, Inc

Houston, Texas, United States

Site Status

Willowbend Health and Wellness

Plano, Texas, United States

Site Status

InVisions Consultants, LLC c/o Northeast Ob/Gyn

San Antonio, Texas, United States

Site Status

King's Daughter Clinic

Temple, Texas, United States

Site Status

Tanner Clinic

Layton, Utah, United States

Site Status

Mt. Timpangos Women's Healthcare

Pleasant Grove, Utah, United States

Site Status

Salt Lake Research

Salt Lake City, Utah, United States

Site Status

Salt Lake Women's Center

Sandy City, Utah, United States

Site Status

Tidewater Clinical Research, Inc

Virginia Beach, Virginia, United States

Site Status

Walla Walla Clinic

Walla Walla, Washington, United States

Site Status

Hyperion Clinical Research, LLC

Charleston, West Virginia, United States

Site Status

Aurora Advanced Healthcare, Inc

Milwaukee, Wisconsin, United States

Site Status

Institute of Kidney Disease and Research Centre

Ahmedabad, Gujarat, India

Site Status

Krishna Hospital Surgical & Maternity 201/2/3 Suryadeep Complex

Vadodara, Gujarat, India

Site Status

Father Muller Medical College Hospital

Mangalore, Kamataka, India

Site Status

Neha Prakash Hospital

Bangalore, Karnataka, India

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KMC Hospital

Mangalore, Karnataka, India

Site Status

Yenepoya Medical College and Hospital

Mangalore, Karnataka, India

Site Status

Om Women's Hospital

Nagpur, Maharashtra, India

Site Status

Avanti Institute of Cardiology

Nagpur, Maharashtra, India

Site Status

Nagpur Test Tube Baby Centre

Nagpur, Maharashtra, India

Site Status

VSG Healthcare, Dr. Ganorkar Hospital

Nashik, Maharashtra, India

Site Status

Nivedita Hospital

Nashik, Maharashtra, India

Site Status

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashtra, India

Site Status

KEM Hospital Research Centre

Pune, Maharashtra, India

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Dr. D. Y. Patil Medical College & Hospital

Pune, Maharashtra, India

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Sri Ramachandra Medical College

Chennai, Tamil Nadu, India

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Chopra Nursing and Maternity Home

Agra, , India

Site Status

Yashoda Super Speciality Hospital

Ghaziabad, , India

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Government Maternity Hospital

Hyderabad, , India

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Government Maternity Hospital

Hyderabad, , India

Site Status

Makker Medical Center

Lucknow, , India

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M.K.W. Hospital and Research Centre

New Delhi, , India

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Sri Ramachandra Medical College

Tamil Nadu, , India

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Ponce School of Medicine

Ponce, , Puerto Rico

Site Status

Dermatovenerologic Dispensary

Korolyov, Moscow Oblast, Russia

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D.O. Ott Research Institute of Ob/Gyn--Family Planning and Female Health Center

Mendeleevskaya Line, Sankt-Peterburg, Russia

Site Status

D.O. Ott Research Institute of Ob/Gyn--Gynecologic Endocrinology

Mendeleyevskaya, Sankt-Peterburg, Russia

Site Status

Orkli, LLC

V.o., Sankt-Peterburg, Russia

Site Status

Smolensk State Medical Academy of Roszdrav

Smolensk, Smolensk Oblast, Russia

Site Status

Kaluga Regional Dermatovenerologic Dispensary

Kaluga, , Russia

Site Status

Moscow Regional Research Insitute of Obstetrics and Gynecology

Moscow, , Russia

Site Status

Dermatovenerologic Dispensary #15

Moscow, , Russia

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Family Planning and Reproductive Centre

Moscow, , Russia

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The Peoples' Friendship University of Russia

Moscow, , Russia

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City Clinical Hospital #52

Moscow, , Russia

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City Clinical Hospital #31

Moscow, , Russia

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Clinic of Skin and Sexual Transmitted Diseases

Moscow, , Russia

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City Clinical Hospital #51

Moscow, , Russia

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Nizhegorodskiy Dermatovenerologic Scientific Research Institute of Federal Agency for Public Health and Human Services

Nizhny Novgorod, , Russia

Site Status

Regional Dermatovenerologic Dispensary

Rostov-on-Don, , Russia

Site Status

Ryazan Regional Clinical Dermatovenerologic Dispensary

Ryazan, , Russia

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Juventa--Reproductive Health

Saint Petersburg, , Russia

Site Status

Medical Mycology Scientific Research Institute at St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav

Saint Petersburg, , Russia

Site Status

442 District Military Clinical Hospital of Leningradsky Military District

Saint Petersburg, , Russia

Site Status

City Dermatovenerologic Dispensary

Saint Petersburg, , Russia

Site Status

S.M. Kirov Military Medical Academy, MoD of the Russian Federation

Saint Petersburg, , Russia

Site Status

L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#321

Saint Petersburg, , Russia

Site Status

L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#322

Saint Petersburg, , Russia

Site Status

Leningradskiy Regional Clinical Hospital

Saint Petersburg, , Russia

Site Status

Family Planning and Reproductive Centre

Saint Petersburg, , Russia

Site Status

St. Petersburg State I.I. Mechnikov Medical Academy of Roszdrav

Saint Petersburg, , Russia

Site Status

Andros Clinic, LLC

Saint Petersburg, , Russia

Site Status

Smolensk Dermatovenerologic Dispensary

Smolensk, , Russia

Site Status

Countries

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United States India Puerto Rico Russia

Other Identifiers

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CBC-302-602-622467

Identifier Type: -

Identifier Source: org_study_id

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