Clinical trial NCT00616330: Vaginal Infection Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvovaginitis
Vaginitis
Lead sponsor: Lumara Health, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 1443
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Clinical symptom resolution.
timeFrame: baseline, 7 to 10 days and 21 to 30 days
Secondary outcomes:
measure: Yeast Culture for Candida
timeFrame: baseline, 7 to 10 days and 21 to 30 days
measure: Gram stain Nugent score
timeFrame: baseline, 7 to 10 days and 21 to 30 days
measure: Saline wet mount for clue cells
timeFrame: baseline, 7 to 10 days and 21 to 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Consultants, Inc
state: Alabama
city: Birmingham
country: United States
facility: Jefferson Clinic, PC
state: Alabama
city: Enterprise
country: United States
facility: Choice Research, LLC
state: Alabama
city: Chandler
country: United States
facility: Star W. Research
state: Arizona
city: Glendale
country: United States
facility: Precision Trials, LLC/Desert West OB/GYN
state: Arizona
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials LLC
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research - Tucson
state: Arizona
city: Jonesboro
country: United States
facility: NEA Women's Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Primary Care Clinic, PA
state: Arkansas
city: Little Rock
country: United States
facility: The Woman's Clinic, P.A.
state: Arkansas
city: Searcy
country: United States
facility: Precision Clinical Research
state: Arkansas
city: Carmichael
country: United States
facility: Med Center
state: California
city: Dinuba
country: United States
facility: Universal Biopharma Research Institute, Inc./Alta Family Health Clinic, Inc.
state: California
city: Fresno
country: United States
facility: Sierra Medical Research
state: California
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: San Diego
country: United States
facility: San Diego Clinical Research Center
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Lakewood
country: United States
facility: Red Rocks OB/GYN
state: Colorado
city: Pueblo
country: United States
facility: Lynn Institute of Pueblo
state: Colorado
city: Hartford
country: United States
facility: Women's Health Care Associates, PC
state: Connecticut
city: West Hartford
country: United States
facility: Greater Hartford Womens Association/Women's Health
state: Connecticut
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research
state: Florida
city: Tampa
country: United States
facility: Insignia Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medical Research Institute
state: Georgia
city: Bogart
country: United States
facility: AMR Research Associates
state: Georgia
city: Decatur
country: United States
facility: Medical Network for Educators and Research
state: Georgia
city: Decatur
country: United States
facility: Soapstone Center for Clinical Research
state: Georgia
city: Douglasville
country: United States
facility: Atlanta West Women's Center
state: Georgia
city: Boise
country: United States
facility: The Woman's Clinic
state: Idaho
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialists
state: Idaho
city: Champaign
country: United States
facility: Womans Health Practice, LLC
state: Illinois
city: South Bend
country: United States
facility: Northern Indiana Womens Health Research
state: Indiana
city: Mandeville
country: United States
facility: Clinical Trials Management
state: Louisiana
city: Shreveport
country: United States
facility: Regional Research Specialists, LLC
state: Louisiana
city: Fall River
country: United States
facility: New England Center for Clinical Research, Inc.
state: Massachusetts
city: Haverhill
country: United States
facility: Activmed Practices & Research, Inc.
state: Massachusetts
city: New Bedford
country: United States
facility: Healthcare for Women
state: Massachusetts
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine and Urogynecology Institute of Michigan
state: Michigan
city: Paw Paw
country: United States
facility: Women's Health Care Specialists, PC
state: Michigan
city: St. Louis
country: United States
facility: Women's Health Partner
state: Missouri
city: St. Louis
country: United States
facility: Consultants in Women's Healthcare
state: Missouri
city: St. Louis
country: United States
facility: New Ballas OB-GYN, Inc.
state: Missouri
city: Reno
country: United States
facility: The Medical Group of Northern Nevada
state: Nevada
city: Port Jefferson
country: United States
facility: Suffolk Ob/Gyn
state: New York
city: Woodbury
country: United States
facility: Preferred OB/GYN/ Women's Health
state: New York
city: Chapel Hill
country: United States
facility: Eastowne OB-GYN and Infertility
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Valaores & Lewis Obstetrics & Gynocology
state: North Carolina
city: Bismark
country: United States
facility: Mid Dakota Clinic Center for Women
state: North Dakota
city: Columbus
country: United States
facility: Complete Healthcare for Women
state: Ohio
city: Englewood
country: United States
facility: HWC Women's Research Center
state: Ohio
city: Gallipolis
country: United States
facility: Holzer Clinic
state: Ohio
city: Eugene
country: United States
facility: Pacific Women's Center, LLC
state: Oregon
city: Medford
country: United States
facility: Medford Women's Clinic, LLP
state: Oregon
city: Hopwood
country: United States
facility: Laurel Highlands Ob/Gyn, PC
state: Pennsylvania
city: Natrona Heights
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Germantown
country: United States
facility: Associates Ob/Gyn
state: Tennessee
city: Memphis
country: United States
facility: Women's Care Center, PLC
state: Tennessee
city: Austin
country: United States
facility: Women Partners in Health
state: Texas
city: Corpus Christi
country: United States
facility: Advanced Research Associates
state: Texas
city: El Paso
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: Planned Parenthood of Houston
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas Clinical Research Center
state: Texas
city: Houston
country: United States
facility: TMC Life Research, Inc
state: Texas
city: Irving
country: United States
facility: Bexar Clinical Trials, LLC
state: Texas
city: Plano
country: United States
facility: Willowbend Health and Wellness
state: Texas
city: San Antonio
country: United States
facility: InVisions Consultants, LLC c/o Northeast Ob/Gyn
state: Texas
city: Temple
country: United States
facility: King's Daughter Clinic
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Pleasant Grove
country: United States
facility: Mt. Timpangos Women's Healthcare
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Sandy
country: United States
facility: Salt Lake Women's Center
state: Utah
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research, Inc
state: Virginia
city: Walla Walla
country: United States
facility: Walla Walla Clinic
state: Washington
city: Charleston
country: United States
facility: Hyperion Clinical Research, LLC
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare, Inc
state: Wisconsin
city: Ahmedabad
country: India
facility: Institute of Kidney Disease and Research Centre
state: Gujarat
city: Vadodara
country: India
facility: Krishna Hospital Surgical & Maternity 201/2/3 Suryadeep Complex
state: Gujarat
city: Mangalore
country: India
facility: Father Muller Medical College Hospital
state: Kamataka
city: Bangalore
country: India
facility: Neha Prakash Hospital
state: Karnataka
city: Mangalore
country: India
facility: KMC Hospital
state: Karnataka
city: Mangalore
country: India
facility: Yenepoya Medical College and Hospital
state: Karnataka
city: Nagpur
country: India
facility: Om Women's Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Avanti Institute of Cardiology
state: Maharashtra
city: Nagpur
country: India
facility: Nagpur Test Tube Baby Centre
state: Maharashtra
city: Nashik
country: India
facility: VSG Healthcare, Dr. Ganorkar Hospital
state: Maharashtra
city: Nashik
country: India
facility: Nivedita Hospital
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharashtra
city: Pune
country: India
facility: KEM Hospital Research Centre
state: Maharashtra
city: Pune
country: India
facility: Dr. D. Y. Patil Medical College & Hospital
state: Maharashtra
city: Chennai
country: India
facility: Sri Ramachandra Medical College
state: Tamil Nadu
city: Agra
country: India
facility: Chopra Nursing and Maternity Home
city: Ghaziabad
country: India
facility: Yashoda Super Speciality Hospital
city: Hyderabad
country: India
facility: Government Maternity Hospital
city: Hyderabad
country: India
facility: Government Maternity Hospital
city: Lucknow
country: India
facility: Makker Medical Center
city: New Delhi
country: India
facility: M.K.W. Hospital and Research Centre
city: Tamil Nadu
country: India
facility: Sri Ramachandra Medical College
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine
city: Korolev
country: Russian Federation
facility: Dermatovenerologic Dispensary
state: Moscow Region
city: Mendeleevskaya line
country: Russian Federation
facility: D.O. Ott Research Institute of Ob/Gyn--Family Planning and Female Health Center
state: Saint Petersburg
city: Mendeleyevskaya
country: Russian Federation
facility: D.O. Ott Research Institute of Ob/Gyn--Gynecologic Endocrinology
state: Saint Petersburg
city: V.o.
country: Russian Federation
facility: Orkli, LLC
state: Saint Petersburg
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical Academy of Roszdrav
state: Smolensk Region
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Dermatovenerologic Dispensary
city: Moscow
country: Russian Federation
facility: Moscow Regional Research Insitute of Obstetrics and Gynecology
city: Moscow
country: Russian Federation
facility: Dermatovenerologic Dispensary #15
city: Moscow
country: Russian Federation
facility: Family Planning and Reproductive Centre
city: Moscow
country: Russian Federation
facility: The Peoples' Friendship University of Russia
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #52
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #31
city: Moscow
country: Russian Federation
facility: Clinic of Skin and Sexual Transmitted Diseases
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #51
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhegorodskiy Dermatovenerologic Scientific Research Institute of Federal Agency for Public Health and Human Services
city: Rostov-on-Don
country: Russian Federation
facility: Regional Dermatovenerologic Dispensary
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Dermatovenerologic Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Juventa--Reproductive Health
city: Saint Petersburg
country: Russian Federation
facility: 442 District Military Clinical Hospital of Leningradsky Military District
city: Saint Petersburg
country: Russian Federation
facility: City Dermatovenerologic Dispensary
city: Saint Petersburg
country: Russian Federation
facility: S.M. Kirov Military Medical Academy, MoD of the Russian Federation
city: Saint Petersburg
country: Russian Federation
facility: L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#321
city: Saint Petersburg
country: Russian Federation
facility: L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#322
city: Saint Petersburg
country: Russian Federation
facility: Leningradskiy Regional Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: Family Planning and Reproductive Centre
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State I.I. Mechnikov Medical Academy of Roszdrav
city: Saint Petersburg
country: Russian Federation
facility: Andros Clinic, LLC
city: Smolensk
country: Russian Federation
facility: Smolensk Dermatovenerologic Dispensary
city: St. Petersburg
country: Russian Federation
facility: Medical Mycology Scientific Research Institute at St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav
Study officials:
affiliation: Lumara Health, Inc.
name: Jim Joffrion
role: STUDY_DIRECTOR
References: