Vaginal Infection Study

Condition(s) targeted: Vulvovaginitis; Vaginitis

Intervention: clindamycin phosphate/butoconazole nitrate (Drug); clindamycin phosphate (Drug); butoconazole nitrate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: KV Pharmaceutical Company

Official(s) and/or principal investigator(s):
Chang Lee, MD, Study Director, Affiliation: KV Pharmaceutical Company

Overall contact:
Chang Lee, MD, Phone: 877-567-7676

This study will evaluate the efficacy and safety of a vaginal product compared with that of other vaginal products and placebo in the treatment of vaginal infections.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Primary outcome: The primary outcome measure of the study will be clinical symptom resolution.

Secondary outcome: Secondary outcome measures will include laboratory assessments of presence or absence of vaginal infection.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

Chang Lee, MD, Phone: 877-567-7676

Ponce School of Medicine, Ponce 00716, Puerto Rico; Completed

Ryazan Regional Clinical Dermatovenerologic Dispensary, Ryazan 390046, Russian Federation; Recruiting

Smolensk Dermatovenerologic Dispensary, Smolensk 214000, Russian Federation; Recruiting

Juventa--Reproductive Health, Saint Petersburg 190020, Russian Federation; Recruiting

Family Planning and Reproductive Centre, Saint Petersburg 195008, Russian Federation; Recruiting

Nizhegorodskiy Dermatovenerologic Scientific Research Institute of Federal Agency for Public Health and Human Services, Nizhny Novgorod 603950, Russian Federation; Recruiting

City Clinical Hospital #31, Moscow 119415, Russian Federation; Recruiting

Kaluga Regional Dermatovenerologic Dispensary, Kaluga 24800, Russian Federation; Recruiting

Regional Dermatovenerologic Dispensary, Rostov-on-Don 344007, Russian Federation; Recruiting

Family Planning and Reproductive Centre, Moscow 117152, Russian Federation; Recruiting

The Peoples' Friendship University of Russia, Moscow 117198, Russian Federation; Recruiting

City Clinical Hospital #52, Moscow 117997, Russian Federation; Recruiting

Leningradskiy Regional Clinical Hospital, Saint Petersburg 194291, Russian Federation; Recruiting

Clinic of Skin and Sexual Transmitted Diseases, Moscow 119435, Russian Federation; Recruiting

City Clinical Hospital #51, Moscow 121309, Russian Federation; Recruiting

Moscow Regional Research Insitute of Obstetrics and Gynecology, Moscow 101000, Russian Federation; Recruiting

L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#321, Saint Petersburg 194291, Russian Federation; Recruiting

L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#322, Saint Petersburg 194291, Russian Federation; Recruiting

S.M. Kirov Military Medical Academy, MoD of the Russian Federation, Saint Petersburg 194044, Russian Federation; Recruiting

City Dermatovenerologic Dispensary, Saint Petersburg 192102, Russian Federation; Recruiting

442 District Military Clinical Hospital of Leningradsky Military District, Saint Petersburg 191124, Russian Federation; Recruiting

Dermatovenerologic Dispensary #15, Moscow 111538, Russian Federation; Recruiting

Medical Mycology Scientific Research Institute at St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav, St. Petersburg 191015, Russian Federation; Recruiting

Andros Clinic, LLC, Saint Petersburg 197136, Russian Federation; Recruiting

St. Petersburg State I.I. Mechnikov Medical Academy of Roszdrav, Saint Petersburg 195067, Russian Federation; Recruiting

Jefferson Clinic, PC, Birmingham, Alabama 35233, United States; Recruiting

Choice Research, LLC, Enterprise, Alabama 36330, United States; Recruiting

Clinical Research Consultants, Inc, Birmingham, Alabama 35209, United States; Completed

Visions Clinical Research - Tucson, Tucson, Arizona 85712, United States; Recruiting

Women's Health Research, Phoenix, Arizona 85015, United States; Recruiting

Precision Trials LLC, Phoenix, Arizona 85032, United States; Recruiting

Precision Trials, LLC/Desert West OB/GYN, Glendale, Arizona 85304, United States; Active, not recruiting

Star W. Research, Chandler, Arizona 85225, United States; Active, not recruiting

NEA Women's Clinic, Jonesboro, Arkansas 33760, United States; Recruiting

Precision Clinical Research, Searcy, Arkansas 72143, United States; Active, not recruiting

The Woman's Clinic, P.A., Little Rock, Arkansas 72205, United States; Active, not recruiting

Arkansas Primary Care Clinic, PA, Little Rock, Arkansas 72204, United States; Active, not recruiting

Universal Biopharma Research Institute, Inc./Alta Family Health Clinic, Inc., Dinuba, California 93618, United States; Active, not recruiting

Sierra Medical Research, Fresno, California 93611, United States; Active, not recruiting

San Diego Clinical Research Center, San Diego, California 92103, United States; Completed

Med Center, Carmichael, California 95608, United States; Completed

Grossmont Center for Clinical Research, La Mesa, California 91942, United States; Recruiting

Lynn Institute of the Rockies, Colorado Springs, Colorado 80909, United States; Completed

Lynn Institute of Pueblo, Pueblo, Colorado 81001, United States; Completed

Red Rocks OB/GYN, Lakewood, Colorado 80228, United States; Active, not recruiting

Greater Hartford Womens Association/Women's Health, West Hartford, Connecticut 06117, United States; Active, not recruiting

Women's Health Care Associates, PC, Hartford, Connecticut 06105, United States; Recruiting

Insignia Clinical Research, Tampa, Florida 33607, United States; Recruiting

Women's Medical Research Group, LLC, Clearwater, Florida 33759, United States; Active, not recruiting

Physician Care Clinical Research, Sarasota, Florida 34239, United States; Active, not recruiting

Comprehensive Clinical Trials, LLC, West Palm Beach, Florida 33409, United States; Recruiting

Segal Institute for Clinical Research, North Miami, Florida 33161, United States; Recruiting

AMR Research Associates, Bogart, Georgia 30622, United States; Completed

Atlanta West Women's Center, Douglasville, Georgia 30134, United States; Recruiting

Medical Network for Educators and Research, Decatur, Georgia 30033, United States; Recruiting

Soapstone Center for Clinical Research, Decatur, Georgia 30034, United States; Active, not recruiting

Atlanta Medical Research Institute, Alpharetta, Georgia 30005, United States; Active, not recruiting

Institute of Kidney Disease and Research Centre, Ahmedabad, Gujarat 380016, India; Recruiting

The Woman's Clinic, Boise, Idaho 83712, United States; Active, not recruiting

Rosemark Women Care Specialists, Idaho Falls, Idaho 83404, United States; Recruiting

Womans Health Practice, LLC, Champaign, Illinois 61820, United States; Recruiting

Northern Indiana Womens Health Research, South Bend, Indiana 46601, United States; Recruiting

Yenepoya Medical College and Hospital, Mangalore, Karnataka 575018, India; Recruiting

Neha Prakash Hospital, Bangalore, Karnataka 560064, India; Recruiting

KMC Hospital, Mangalore, Karnataka 575001, India; Recruiting

Regional Research Specialists, LLC, Shreveport, Louisiana 71106, United States; Completed

Clinical Trials Management, Mandeville, Louisiana 70471, United States; Active, not recruiting

Avanti Institute of Cardiology, Nagpur, Maharashtra 440012, India; Recruiting

Om Women's Hospital, Nagpur, Maharashtra 440010, India; Recruiting

Deenanath Mangeshkar Hospital and Research Centre, Pune, Maharashtra 411004, India; Recruiting

KEM Hospital Research Centre, Pune, Maharashtra 411011, India; Recruiting

Activmed Practices & Research, Inc., Haverhill, Massachusetts 01830, United States; Active, not recruiting

New England Center for Clinical Research, Inc., Fall River, Massachusetts 02720, United States; Recruiting

Healthcare for Women, New Bedford, Massachusetts 02740, United States; Recruiting

Female Pelvic Medicine and Urogynecology Institute of Michigan, Grand Rapids, Michigan 49506, United States; Active, not recruiting

Women's Health Care Specialists, PC, Paw Paw, Michigan 49079, United States; Active, not recruiting

Women's Health Partner, St. Louis, Missouri 63117, United States; Completed

New Ballas OB-GYN, Inc., St. Louis, Missouri 63141, United States; Completed

Consultants in Women's Healthcare, St. Louis, Missouri 63131, United States; Recruiting

Dermatovenerologic Dispensary, Korolev, Moscow Region 141074, Russian Federation; Recruiting

The Medical Group of Northern Nevada, Reno, Nevada 89502, United States; Active, not recruiting

Preferred OB/GYN/ Women's Health, Woodbury, New York 11797, United States; Active, not recruiting

Suffolk Ob/Gyn, Port Jefferson, New York 11777, United States; Recruiting

Valaores & Lewis Obstetrics & Gynocology, Winston-Salem, North Carolina 27103, United States; Recruiting

Eastern Carolina Women's Center, New Bern, North Carolina 28562, United States; Completed

Eastowne OB-GYN and Infertility, Chapel Hill, North Carolina 27514, United States; Completed

Hawthorne Medical Research, Inc., Winston-Salem, North Carolina 27103, United States; Active, not recruiting

Mid Dakota Clinic Center for Women, Bismark, North Dakota 58501, United States; Recruiting

Holzer Clinic, Gallipolis, Ohio 45631, United States; Completed

HWC Women's Research Center, Englewood, Ohio 45322, United States; Active, not recruiting

Complete Healthcare for Women, Columbus, Ohio 43231, United States; Active, not recruiting

Medford Women's Clinic, LLP, Medford, Oregon 97504, United States; Active, not recruiting

Pacific Women's Center, LLC, Eugene, Oregon 97401, United States; Active, not recruiting

Clinical Trials Research Services, LLC, Natrona Heights, Pennsylvania 15065, United States; Recruiting

Laurel Highlands Ob/Gyn, PC, Hopwood, Pennsylvania 15445, United States; Recruiting

D.O. Ott Research Institute of Ob/Gyn--Gynecologic Endocrinology, Mendeleyevskaya, Saint Petersburg 199034, Russian Federation; Recruiting

D.O. Ott Research Institute of Ob/Gyn--Family Planning and Female Health Center, Mendeleevskaya line, Saint Petersburg 199034, Russian Federation; Recruiting

Orkli, LLC, V.O., Saint Petersburg 199178, Russian Federation; Recruiting

Smolensk State Medical Academy of Roszdrav, Smolensk, Smolensk Region 214019, Russian Federation; Recruiting

Sri Ramachandra Medical College, Chennai, Tamil Nadu 600116, India; Recruiting

Women's Care Center, PLC, Memphis, Tennessee 38119, United States; Recruiting

Associates Ob/Gyn, Germantown, Tennessee 38138, United States; Recruiting

Planned Parenthood of Houston, Houston, Texas 77004, United States; Completed

Bexar Clinical Trials, LLC, Irving, Texas 75061, United States; Completed

Advanced Research Associates, Corpus Christi, Texas 78414, United States; Recruiting

The Woman's Hospital of Texas Clinical Research Center, Houston, Texas 77054, United States; Recruiting

Willowbend Health and Wellness, Plano, Texas 75093, United States; Completed

TMC Life Research, Inc, Houston, Texas 77054, United States; Recruiting

Research Across America, El Paso, Texas 79902, United States; Active, not recruiting

King's Daughter Clinic, Temple, Texas 76502, United States; Recruiting

Women Partners in Health, Austin, Texas 78705, United States; Completed

InVisions Consultants, LLC c/o Northeast Ob/Gyn, San Antonio, Texas 78217, United States; Recruiting

Salt Lake Women's Center, Sandy, Utah 84070, United States; Recruiting

Salt Lake Research, Salt Lake City, Utah 84107, United States; Active, not recruiting

Mt. Timpangos Women's Healthcare, Pleasant Grove, Utah 84062, United States; Completed

Tanner Clinic, Layton, Utah 84041, United States; Recruiting

Tidewater Clinical Research, Inc, Virginia Beach, Virginia 23456, United States; Active, not recruiting

Walla Walla Clinic, Walla Walla, Washington 99362, United States; Completed

Hyperion Clinical Research, LLC, Charleston, West Virginia 25301, United States; Active, not recruiting

Aurora Advanced Healthcare, Inc, Milwaukee, Wisconsin 53209, United States; Recruiting

Starting date: January 2008
Last updated: January 22, 2009