Vaginal Infection Study 2

Condition(s) targeted: Vaginal Infection

Intervention: clindamycin phosphate/butoconazole nitrate (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 another vaginal product 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

State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid, Moscow 107076, Russian Federation; Recruiting

Clinical Dermatovenerologic Dispensary, Krasnodar 350020, Russian Federation; Recruiting

Medical University Clinic, Kazan 420012, Russian Federation; Recruiting

Russian Medical Academy of Postgraduate Studies of Roszdrav, Moscow 123995, Russian Federation; Recruiting

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

Medical Research Institute, LLC, Saint Petersburg 196084, Russian Federation; Recruiting

Republican Dermatovenerologic Dispensary, MoH of Karelia Republic, Petrozavodsk 185002, Russian Federation; Recruiting

Novisibirsk Municipal Dermatovenerologic Dispensary #1, Novosibirsk 630082, Russian Federation; Recruiting

Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC, Voronezh 394024, Russian Federation; Recruiting

State Health Care Institution Moscow City Clinical Hospital #12, Moscow 115516, Russian Federation; Recruiting

Yaroslavl Regional Maternity Hospital, Yaroslavl 150003, Russian Federation; Recruiting

Maximillian City Hospital #28, Saint Petersburg 190000, Russian Federation; Recruiting

State Health Care Institution Orenburg Regional Clinical Hospital #2, Orenburg 460000, Russian Federation; Recruiting

City Multifield Hospital, Saint Petersburg 194354, Russian Federation; Recruiting

City Hospital #26, Saint Petersburg 196247, Russian Federation; Recruiting

State Healthcare Institution Moscow Clinical Hospital #68, Moscow 127473, Russian Federation; Recruiting

Voronezh Regional Clinical Dermatovenerologic Dispensary, Voronezh 394038, Russian Federation; Recruiting

State Healthcare Institution Regional Dermatovenerologic Dispensary, Saint Petersburg 190020, Russian Federation; Recruiting

St. Petersburg I.P. Pavlov State Medical University of Roszdrav, Saint Petersburg 197022, Russian Federation; Recruiting

Drug Research Analysis Corp, Montgomery, Alabama 36106, United States; Active, not recruiting

Brookwood Ob-GYN, PC/Women's Medical Plaza, Birmingham, Alabama 35209, United States; Active, not recruiting

Drug Research and Analysis Corp., Montgomery, Alabama 36106, United States; Active, not recruiting

The Woman's Clinic, PA, Little Rock, Arkansas 72205, United States; Recruiting

Ob/Gyn Associates, Jonesboro, Arkansas 72401, United States; Not yet recruiting

Peak Health Medical Group, Los Angeles, California 90025, United States; Active, not recruiting

Women's Health Care at Frost Street, San Diego, California 30035, United States; Recruiting

Steven Freedman, MD, Inc., West Hills, California 91307, United States; Recruiting

Red Rocks OB/GYN, Lakewood, Colorado 80228, United States; Recruiting

SHE Medical Center, Hartford, Connecticut 06105, United States; Recruiting

University Clinical Research, Pines, Florida 33024, United States; Active, not recruiting

Suncoast Clinical Research, Palm Harbor, Florida 34684, United States; Active, not recruiting

Debra Hemsath, MD, Largo, Florida 33774, United States; Active, not recruiting

International Research Associates, Miami, Florida 33156, United States; Not yet recruiting

New Millennium Ob/Gyn, Riverdale, Georgia 30274, United States; Recruiting

Total Women's Health and Wellness, Decatur, Georgia 30030, United States; Not yet recruiting

Dekalb Gynecology Associates, Decatur, Georgia 30035, United States; Not yet recruiting

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

The Iowa Clinic Department of Ob/Gyn, West Des Moines, Iowa 50266, United States; Not yet recruiting

Bangalore Diabetes Centre, Bangalore, Karnataka 560043, India; Recruiting

AJ Medical College and Hospital, Mangalore, Karnataka 575004, India; Recruiting

Steven Z. Lenowitz, MD, LLC, Bel Air, Maryland 21014, United States; Not yet recruiting

Women's Health Research Center, LLC, Lawrenceville, New Jersey 08648, United States; Recruiting

Lawrence Ob/Gyn Associates, Lawrenceville, New Jersey 08648, United States; Recruiting

Meridian Clinical Research, LLC, Greensboro, North Carolina 27455, United States; Active, not recruiting

Women's Wellness Center, Fayetteville, North Carolina 28304, United States; Not yet recruiting

Tirangle Ob/Gyn, Cary, North Carolina 27518, United States; Not yet recruiting

Family Practice Center of Wadsworth, Inc, Wadsworth, Ohio 44281, United States; Active, not recruiting

Holzer Clinic, Gallipolis, Ohio 45631, United States; Active, not recruiting

Lynn Institute of Norman, Norman, Oklahoma 73069, United States; Active, not recruiting

Pacific Women's Center, LLC/Clinical Trials of America, Eugene, Oregon 97401, United States; Active, not recruiting

Center for Women's Health of Lansdale, Lansdale, Pennsylvania 19446, United States; Not yet recruiting

Sharda Hospital, Jaipur, Rajasthan 302020, India; Recruiting

Mayani Hosptial and Research Centre, Ajmer, Rajasthan 305001, India; Recruiting

Kurortniy Ward City Hospital #40, Sestroretsk, Saint Petersburg 197706, Russian Federation; Recruiting

The Family Healthcare Center, PA, Clinton, South Carolina 29325, United States; Active, not recruiting

Greenville Pharmaceutical Research, Greenville, South Carolina 29615, United States; Active, not recruiting

Creekside Women's Care, Charleston, South Carolina 29414, United States; Not yet recruiting

James T. Martin, Jr., MD, Ob/Gyn, North Charleston, South Carolina 29406, United States; Not yet recruiting

Brown Clinical, PLLP, Watertown, South Dakota 57201, United States; Active, not recruiting

Gynecology and Obstetrics, Memphis, Tennessee 38120, United States; Active, not recruiting

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

Mid-South Ob/Gyn, Memphis, Tennessee 38120, United States; Recruiting

Kaner Medical Group, PA, Euless, Texas 76039, United States; Completed

Advanced Reserch Associates, McAllen, Texas 78505, United States; Active, not recruiting

Willowbend Health & Wellness, Plano, Texas 75093, United States; Active, not recruiting

Taylor/Wade Medical, Bountiful, Utah 84010, United States; Recruiting

MV Hospital and Research Centre, Lucknow, Uttar Pradesh 226003, India; Recruiting

Vermont Urogynecology Associates, PC, Williston, Vermont 05495, United States; Active, not recruiting

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

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