Clinical trial NCT00694928: Vaginal Infection Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaginal Infection
Lead sponsor: Lumara Health, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-11
Enrollment: 843
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 another vaginal product 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: Brookwood Ob-GYN, PC/Women's Medical Plaza
state: Alabama
city: Montgomery
country: United States
facility: Drug Research Analysis Corp
state: Alabama
city: Montgomery
country: United States
facility: Drug Research and Analysis Corp.
state: Alabama
city: Jonesboro
country: United States
facility: Ob/Gyn Associates
state: Arkansas
city: Little Rock
country: United States
facility: The Woman's Clinic, PA
state: Arkansas
city: Los Angeles
country: United States
facility: Peak Health Medical Group
state: California
city: San Diego
country: United States
facility: Women's Health Care at Frost Street
state: California
city: West Hills
country: United States
facility: Steven Freedman, MD, Inc.
state: California
city: Lakewood
country: United States
facility: Red Rocks OB/GYN
state: Colorado
city: Hartford
country: United States
facility: SHE Medical Center
state: Connecticut
city: Largo
country: United States
facility: Debra Hemsath, MD
state: Florida
city: Miami
country: United States
facility: International Research Associates
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Pines
country: United States
facility: University Clinical Research
state: Florida
city: Decatur
country: United States
facility: Total Women's Health and Wellness
state: Georgia
city: Decatur
country: United States
facility: Dekalb Gynecology Associates
state: Georgia
city: Riverdale
country: United States
facility: New Millennium Ob/Gyn
state: Georgia
city: Boise
country: United States
facility: The Woman's Clinic
state: Idaho
city: West Des Moines
country: United States
facility: The Iowa Clinic Department of Ob/Gyn
state: Iowa
city: Bel Air
country: United States
facility: Steven Z. Lenowitz, MD, LLC
state: Maryland
city: Lawrenceville
country: United States
facility: Lawrence Ob/Gyn Associates
state: New Jersey
city: Lawrenceville
country: United States
facility: Women's Health Research Center, LLC
state: New Jersey
city: Cary
country: United States
facility: Triangle Ob/Gyn
state: North Carolina
city: Fayetteville
country: United States
facility: Women's Wellness Center
state: North Carolina
city: Greensboro
country: United States
facility: Meridian Clinical Research, LLC
state: North Carolina
city: Gallipolis
country: United States
facility: Holzer Clinic
state: Ohio
city: Wadsworth
country: United States
facility: Family Practice Center of Wadsworth, Inc
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Eugene
country: United States
facility: Pacific Women's Center, LLC/Clinical Trials of America
state: Oregon
city: Lansdale
country: United States
facility: Center for Women's Health of Lansdale
state: Pennsylvania
city: Charleston
country: United States
facility: Creekside Women's Care
state: South Carolina
city: Clinton
country: United States
facility: The Family Healthcare Center, PA
state: South Carolina
city: Greenville
country: United States
facility: Greenville Pharmaceutical Research
state: South Carolina
city: North Charleston
country: United States
facility: James T. Martin, Jr., MD, Ob/Gyn
state: South Carolina
city: Watertown
country: United States
facility: Brown Clinical, PLLP
state: South Dakota
city: Memphis
country: United States
facility: Gynecology and Obstetrics
state: Tennessee
city: Memphis
country: United States
facility: Mid-South Ob/Gyn
state: Tennessee
city: Euless
country: United States
facility: Kaner Medical Group, PA
state: Texas
city: McAllen
country: United States
facility: Advanced Reserch Associates
state: Texas
city: Plano
country: United States
facility: Willowbend Health & Wellness
state: Texas
city: Bountiful
country: United States
facility: Taylor/Wade Medical
state: Utah
city: Williston
country: United States
facility: Vermont Urogynecology Associates, PC
state: Vermont
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research
state: Virginia
city: Bangalore
country: India
facility: Bangalore Diabetes Centre
state: Karnataka
city: Mangalore
country: India
facility: AJ Medical College and Hospital
state: Karnataka
city: Ajmer
country: India
facility: Mayani Hosptial and Research Centre
state: Rajasthan
city: Jaipur
country: India
facility: Sharda Hospital
state: Rajasthan
city: Lucknow
country: India
facility: MV Hospital and Research Centre
state: Uttar Pradesh
city: Hyderabad
country: India
facility: Care Hospital
city: Jaipur
country: India
facility: Shri Krishna Hospital
city: Ranga Reddy District
country: India
facility: Mediciti Institute of Medical Sciences
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences
city: Visakhapatnam
country: India
facility: King George Hospital
city: Sestroretsk
country: Russian Federation
facility: Kurortniy Ward City Hospital #40
state: Saint Petersburg
city: Kazan
country: Russian Federation
facility: Medical University Clinic
city: Krasnodar
country: Russian Federation
facility: Clinical Dermatovenerologic Dispensary
city: Moscow
country: Russian Federation
facility: State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid
city: Moscow
country: Russian Federation
facility: State Health Care Institution Moscow City Clinical Hospital #12
city: Moscow
country: Russian Federation
facility: Russian Medical Academy of Postgraduate Studies of Roszdrav
city: Moscow
country: Russian Federation
facility: State Healthcare Institution Moscow Clinical Hospital #68
city: Novosibirsk
country: Russian Federation
facility: Novisibirsk Municipal Dermatovenerologic Dispensary #1
city: Orenburg
country: Russian Federation
facility: State Health Care Institution Orenburg Regional Clinical Hospital #2
city: Petrozavodsk
country: Russian Federation
facility: Republican Dermatovenerologic Dispensary, MoH of Karelia Republic
city: Saint Petersburg
country: Russian Federation
facility: Maximillian City Hospital #28
city: Saint Petersburg
country: Russian Federation
facility: State Healthcare Institution Regional 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: City Multifield Hospital
city: Saint Petersburg
country: Russian Federation
facility: Medical Research Institute, LLC
city: Saint Petersburg
country: Russian Federation
facility: City Hospital #26
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg I.P. Pavlov State Medical University of Roszdrav
city: Voronezh
country: Russian Federation
facility: Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Dermatovenerologic Dispensary
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Maternity Hospital
Study officials:
affiliation: Lumara Health, Inc.
name: Jim Joffrion
role: STUDY_DIRECTOR
References: