search
Back to results

Vaginal Infection Study 2

Primary Purpose

Vaginal Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
clindamycin phosphate/butoconazole nitrate
butoconazole nitrate
Sponsored by
Lumara Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Infection

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Brookwood Ob-GYN, PC/Women's Medical Plaza
  • Drug Research Analysis Corp
  • Drug Research and Analysis Corp.
  • Ob/Gyn Associates
  • The Woman's Clinic, PA
  • Peak Health Medical Group
  • Women's Health Care at Frost Street
  • Steven Freedman, MD, Inc.
  • Red Rocks OB/GYN
  • SHE Medical Center
  • Debra Hemsath, MD
  • International Research Associates
  • Suncoast Clinical Research
  • University Clinical Research
  • Total Women's Health and Wellness
  • Dekalb Gynecology Associates
  • New Millennium Ob/Gyn
  • The Woman's Clinic
  • The Iowa Clinic Department of Ob/Gyn
  • Steven Z. Lenowitz, MD, LLC
  • Lawrence Ob/Gyn Associates
  • Women's Health Research Center, LLC
  • Triangle Ob/Gyn
  • Women's Wellness Center
  • Meridian Clinical Research, LLC
  • Holzer Clinic
  • Family Practice Center of Wadsworth, Inc
  • Lynn Institute of Norman
  • Pacific Women's Center, LLC/Clinical Trials of America
  • Center for Women's Health of Lansdale
  • Creekside Women's Care
  • The Family Healthcare Center, PA
  • Greenville Pharmaceutical Research
  • James T. Martin, Jr., MD, Ob/Gyn
  • Brown Clinical, PLLP
  • Gynecology and Obstetrics
  • Mid-South Ob/Gyn
  • Kaner Medical Group, PA
  • Advanced Reserch Associates
  • Willowbend Health & Wellness
  • Taylor/Wade Medical
  • Vermont Urogynecology Associates, PC
  • Tidewater Clinical Research
  • Bangalore Diabetes Centre
  • AJ Medical College and Hospital
  • Mayani Hosptial and Research Centre
  • Sharda Hospital
  • MV Hospital and Research Centre
  • Care Hospital
  • Shri Krishna Hospital
  • Mediciti Institute of Medical Sciences
  • Krishna Institute of Medical Sciences
  • King George Hospital
  • Kurortniy Ward City Hospital #40
  • Medical University Clinic
  • Clinical Dermatovenerologic Dispensary
  • State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid
  • State Health Care Institution Moscow City Clinical Hospital #12
  • Russian Medical Academy of Postgraduate Studies of Roszdrav
  • State Healthcare Institution Moscow Clinical Hospital #68
  • Novisibirsk Municipal Dermatovenerologic Dispensary #1
  • State Health Care Institution Orenburg Regional Clinical Hospital #2
  • Republican Dermatovenerologic Dispensary, MoH of Karelia Republic
  • Maximillian City Hospital #28
  • State Healthcare Institution Regional Dermatovenerologic Dispensary
  • S.M. Kirov Military Medical Academy, MoD of the Russian Federation
  • City Multifield Hospital
  • Medical Research Institute, LLC
  • City Hospital #26
  • St. Petersburg I.P. Pavlov State Medical University of Roszdrav
  • Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC
  • Voronezh Regional Clinical Dermatovenerologic Dispensary
  • Yaroslavl Regional Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

clindamycin phosphate/butoconazole nitrate

butoconazole nitrate

Outcomes

Primary Outcome Measures

Clinical symptom resolution

Secondary Outcome Measures

Yeast Culture for Candida
Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response
Gram Stain Nugent Score
Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution
Saline wet mount for clue cells
Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution

Full Information

First Posted
June 9, 2008
Last Updated
February 29, 2012
Sponsor
Lumara Health, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00694928
Brief Title
Vaginal Infection Study 2
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumara Health, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
843 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
clindamycin phosphate/butoconazole nitrate
Arm Title
2
Arm Type
Active Comparator
Arm Description
butoconazole nitrate
Intervention Type
Drug
Intervention Name(s)
clindamycin phosphate/butoconazole nitrate
Intervention Description
semi-solid, single dose
Intervention Type
Drug
Intervention Name(s)
butoconazole nitrate
Intervention Description
semi-solid, single dose
Primary Outcome Measure Information:
Title
Clinical symptom resolution
Time Frame
baseline, 7 to 10 days and 21 to 30 days
Secondary Outcome Measure Information:
Title
Yeast Culture for Candida
Description
Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response
Time Frame
baseline, 7 to 10 days and 21 to 30 days
Title
Gram Stain Nugent Score
Description
Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution
Time Frame
baseline, 7 to 10 days and 21 to 30 days
Title
Saline wet mount for clue cells
Description
Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution
Time Frame
baseline, 7 to 10 days and 21 to 30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Joffrion
Organizational Affiliation
Lumara Health, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Brookwood Ob-GYN, PC/Women's Medical Plaza
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Drug Research Analysis Corp
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Drug Research and Analysis Corp.
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Ob/Gyn Associates
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
The Woman's Clinic, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Peak Health Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Women's Health Care at Frost Street
City
San Diego
State/Province
California
ZIP/Postal Code
30035
Country
United States
Facility Name
Steven Freedman, MD, Inc.
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Red Rocks OB/GYN
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
SHE Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Debra Hemsath, MD
City
Largo
State/Province
Florida
ZIP/Postal Code
33774
Country
United States
Facility Name
International Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Suncoast Clinical Research
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
University Clinical Research
City
Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Total Women's Health and Wellness
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Dekalb Gynecology Associates
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30035
Country
United States
Facility Name
New Millennium Ob/Gyn
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
The Woman's Clinic
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
The Iowa Clinic Department of Ob/Gyn
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Steven Z. Lenowitz, MD, LLC
City
Bel Air
State/Province
Maryland
ZIP/Postal Code
21014
Country
United States
Facility Name
Lawrence Ob/Gyn Associates
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Women's Health Research Center, LLC
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Triangle Ob/Gyn
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Women's Wellness Center
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27455
Country
United States
Facility Name
Holzer Clinic
City
Gallipolis
State/Province
Ohio
ZIP/Postal Code
45631
Country
United States
Facility Name
Family Practice Center of Wadsworth, Inc
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Pacific Women's Center, LLC/Clinical Trials of America
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Center for Women's Health of Lansdale
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Creekside Women's Care
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
The Family Healthcare Center, PA
City
Clinton
State/Province
South Carolina
ZIP/Postal Code
29325
Country
United States
Facility Name
Greenville Pharmaceutical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
James T. Martin, Jr., MD, Ob/Gyn
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Brown Clinical, PLLP
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Gynecology and Obstetrics
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Mid-South Ob/Gyn
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Kaner Medical Group, PA
City
Euless
State/Province
Texas
ZIP/Postal Code
76039
Country
United States
Facility Name
Advanced Reserch Associates
City
McAllen
State/Province
Texas
ZIP/Postal Code
78505
Country
United States
Facility Name
Willowbend Health & Wellness
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Taylor/Wade Medical
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Vermont Urogynecology Associates, PC
City
Williston
State/Province
Vermont
ZIP/Postal Code
05495
Country
United States
Facility Name
Tidewater Clinical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Bangalore Diabetes Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560043
Country
India
Facility Name
AJ Medical College and Hospital
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575004
Country
India
Facility Name
Mayani Hosptial and Research Centre
City
Ajmer
State/Province
Rajasthan
ZIP/Postal Code
305001
Country
India
Facility Name
Sharda Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302020
Country
India
Facility Name
MV Hospital and Research Centre
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Care Hospital
City
Hyderabad
ZIP/Postal Code
500034
Country
India
Facility Name
Shri Krishna Hospital
City
Jaipur
ZIP/Postal Code
302001
Country
India
Facility Name
Mediciti Institute of Medical Sciences
City
Ranga Reddy District
ZIP/Postal Code
501401
Country
India
Facility Name
Krishna Institute of Medical Sciences
City
Secunderabad
ZIP/Postal Code
500003
Country
India
Facility Name
King George Hospital
City
Visakhapatnam
ZIP/Postal Code
530002
Country
India
Facility Name
Kurortniy Ward City Hospital #40
City
Sestroretsk
State/Province
Saint Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Medical University Clinic
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Clinical Dermatovenerologic Dispensary
City
Krasnodar
ZIP/Postal Code
350020
Country
Russian Federation
Facility Name
State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
State Health Care Institution Moscow City Clinical Hospital #12
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
Facility Name
Russian Medical Academy of Postgraduate Studies of Roszdrav
City
Moscow
ZIP/Postal Code
123995
Country
Russian Federation
Facility Name
State Healthcare Institution Moscow Clinical Hospital #68
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Novisibirsk Municipal Dermatovenerologic Dispensary #1
City
Novosibirsk
ZIP/Postal Code
630082
Country
Russian Federation
Facility Name
State Health Care Institution Orenburg Regional Clinical Hospital #2
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
Republican Dermatovenerologic Dispensary, MoH of Karelia Republic
City
Petrozavodsk
ZIP/Postal Code
185002
Country
Russian Federation
Facility Name
Maximillian City Hospital #28
City
Saint Petersburg
ZIP/Postal Code
190000
Country
Russian Federation
Facility Name
State Healthcare Institution Regional Dermatovenerologic Dispensary
City
Saint Petersburg
ZIP/Postal Code
190020
Country
Russian Federation
Facility Name
S.M. Kirov Military Medical Academy, MoD of the Russian Federation
City
Saint Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
City Multifield Hospital
City
Saint Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Medical Research Institute, LLC
City
Saint Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
City Hospital #26
City
Saint Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
St. Petersburg I.P. Pavlov State Medical University of Roszdrav
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC
City
Voronezh
ZIP/Postal Code
394024
Country
Russian Federation
Facility Name
Voronezh Regional Clinical Dermatovenerologic Dispensary
City
Voronezh
ZIP/Postal Code
394038
Country
Russian Federation
Facility Name
Yaroslavl Regional Maternity Hospital
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Vaginal Infection Study 2

We'll reach out to this number within 24 hrs