Vaginal Infection Study 2

Vaginal Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694928
• Other study ID #: CBC-303-603-622467
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2008
• Last updated: February 29, 2012
• Start date: May 2008
• Est. completion date: November 2009

Study information

• Verified date: February 2012
• Source: Lumara Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 843
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vaginal Infection

Intervention

Drug:
• clindamycin phosphate/butoconazole nitrate
semi-solid, single dose
• butoconazole nitrate
semi-solid, single dose

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Lumara Health, Inc.

Countries where clinical trial is conducted

United States,  India,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical symptom resolution		baseline, 7 to 10 days and 21 to 30 days	No
Secondary	Yeast Culture for Candida	Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response	baseline, 7 to 10 days and 21 to 30 days	No
Secondary	Gram Stain Nugent Score	Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution	baseline, 7 to 10 days and 21 to 30 days	No
Secondary	Saline wet mount for clue cells	Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution	baseline, 7 to 10 days and 21 to 30 days	No