Vaginal Infection Study 2
Sponsor
Lumara Health, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00694928
Collaborator
(none)
843
73
2
18
11.5
0.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
843 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
May 1, 2008
Actual Primary Completion Date
:
Nov 1, 2009
Actual Study Completion Date
:
Nov 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 clindamycin phosphate/butoconazole nitrate |
Drug: clindamycin phosphate/butoconazole nitrate
semi-solid, single dose
|
| Active Comparator: 2 butoconazole nitrate |
Drug: butoconazole nitrate
semi-solid, single dose
|
Outcome Measures
Primary Outcome Measures
- Clinical symptom resolution [baseline, 7 to 10 days and 21 to 30 days]
Secondary Outcome Measures
- Yeast Culture for Candida [baseline, 7 to 10 days and 21 to 30 days]
Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response
- Gram Stain Nugent Score [baseline, 7 to 10 days and 21 to 30 days]
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 [baseline, 7 to 10 days and 21 to 30 days]
Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brookwood Ob-GYN, PC/Women's Medical Plaza | Birmingham | Alabama | United States | 35209 |
| 2 | Drug Research Analysis Corp | Montgomery | Alabama | United States | 36106 |
| 3 | Drug Research and Analysis Corp. | Montgomery | Alabama | United States | 36106 |
| 4 | Ob/Gyn Associates | Jonesboro | Arkansas | United States | 72401 |
| 5 | The Woman's Clinic, PA | Little Rock | Arkansas | United States | 72205 |
| 6 | Peak Health Medical Group | Los Angeles | California | United States | 90025 |
| 7 | Women's Health Care at Frost Street | San Diego | California | United States | 30035 |
| 8 | Steven Freedman, MD, Inc. | West Hills | California | United States | 91307 |
| 9 | Red Rocks OB/GYN | Lakewood | Colorado | United States | 80228 |
| 10 | SHE Medical Center | Hartford | Connecticut | United States | 06105 |
| 11 | Debra Hemsath, MD | Largo | Florida | United States | 33774 |
| 12 | International Research Associates | Miami | Florida | United States | 33156 |
| 13 | Suncoast Clinical Research | Palm Harbor | Florida | United States | 34684 |
| 14 | University Clinical Research | Pines | Florida | United States | 33024 |
| 15 | Total Women's Health and Wellness | Decatur | Georgia | United States | 30030 |
| 16 | Dekalb Gynecology Associates | Decatur | Georgia | United States | 30035 |
| 17 | New Millennium Ob/Gyn | Riverdale | Georgia | United States | 30274 |
| 18 | The Woman's Clinic | Boise | Idaho | United States | 83712 |
| 19 | The Iowa Clinic Department of Ob/Gyn | West Des Moines | Iowa | United States | 50266 |
| 20 | Steven Z. Lenowitz, MD, LLC | Bel Air | Maryland | United States | 21014 |
| 21 | Lawrence Ob/Gyn Associates | Lawrenceville | New Jersey | United States | 08648 |
| 22 | Women's Health Research Center, LLC | Lawrenceville | New Jersey | United States | 08648 |
| 23 | Triangle Ob/Gyn | Cary | North Carolina | United States | 27518 |
| 24 | Women's Wellness Center | Fayetteville | North Carolina | United States | 28304 |
| 25 | Meridian Clinical Research, LLC | Greensboro | North Carolina | United States | 27455 |
| 26 | Holzer Clinic | Gallipolis | Ohio | United States | 45631 |
| 27 | Family Practice Center of Wadsworth, Inc | Wadsworth | Ohio | United States | 44281 |
| 28 | Lynn Institute of Norman | Norman | Oklahoma | United States | 73069 |
| 29 | Pacific Women's Center, LLC/Clinical Trials of America | Eugene | Oregon | United States | 97401 |
| 30 | Center for Women's Health of Lansdale | Lansdale | Pennsylvania | United States | 19446 |
| 31 | Creekside Women's Care | Charleston | South Carolina | United States | 29414 |
| 32 | The Family Healthcare Center, PA | Clinton | South Carolina | United States | 29325 |
| 33 | Greenville Pharmaceutical Research | Greenville | South Carolina | United States | 29615 |
| 34 | James T. Martin, Jr., MD, Ob/Gyn | North Charleston | South Carolina | United States | 29406 |
| 35 | Brown Clinical, PLLP | Watertown | South Dakota | United States | 57201 |
| 36 | Gynecology and Obstetrics | Memphis | Tennessee | United States | 38120 |
| 37 | Mid-South Ob/Gyn | Memphis | Tennessee | United States | 38120 |
| 38 | Kaner Medical Group, PA | Euless | Texas | United States | 76039 |
| 39 | Advanced Reserch Associates | McAllen | Texas | United States | 78505 |
| 40 | Willowbend Health & Wellness | Plano | Texas | United States | 75093 |
| 41 | Taylor/Wade Medical | Bountiful | Utah | United States | 84010 |
| 42 | Vermont Urogynecology Associates, PC | Williston | Vermont | United States | 05495 |
| 43 | Tidewater Clinical Research | Virginia Beach | Virginia | United States | 23456 |
| 44 | Bangalore Diabetes Centre | Bangalore | Karnataka | India | 560043 |
| 45 | AJ Medical College and Hospital | Mangalore | Karnataka | India | 575004 |
| 46 | Mayani Hosptial and Research Centre | Ajmer | Rajasthan | India | 305001 |
| 47 | Sharda Hospital | Jaipur | Rajasthan | India | 302020 |
| 48 | MV Hospital and Research Centre | Lucknow | Uttar Pradesh | India | 226003 |
| 49 | Care Hospital | Hyderabad | India | 500034 | |
| 50 | Shri Krishna Hospital | Jaipur | India | 302001 | |
| 51 | Mediciti Institute of Medical Sciences | Ranga Reddy District | India | 501401 | |
| 52 | Krishna Institute of Medical Sciences | Secunderabad | India | 500003 | |
| 53 | King George Hospital | Visakhapatnam | India | 530002 | |
| 54 | Kurortniy Ward City Hospital #40 | Sestroretsk | Saint Petersburg | Russian Federation | 197706 |
| 55 | Medical University Clinic | Kazan | Russian Federation | 420012 | |
| 56 | Clinical Dermatovenerologic Dispensary | Krasnodar | Russian Federation | 350020 | |
| 57 | State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid | Moscow | Russian Federation | 107076 | |
| 58 | State Health Care Institution Moscow City Clinical Hospital #12 | Moscow | Russian Federation | 115516 | |
| 59 | Russian Medical Academy of Postgraduate Studies of Roszdrav | Moscow | Russian Federation | 123995 | |
| 60 | State Healthcare Institution Moscow Clinical Hospital #68 | Moscow | Russian Federation | 127473 | |
| 61 | Novisibirsk Municipal Dermatovenerologic Dispensary #1 | Novosibirsk | Russian Federation | 630082 | |
| 62 | State Health Care Institution Orenburg Regional Clinical Hospital #2 | Orenburg | Russian Federation | 460000 | |
| 63 | Republican Dermatovenerologic Dispensary, MoH of Karelia Republic | Petrozavodsk | Russian Federation | 185002 | |
| 64 | Maximillian City Hospital #28 | Saint Petersburg | Russian Federation | 190000 | |
| 65 | State Healthcare Institution Regional Dermatovenerologic Dispensary | Saint Petersburg | Russian Federation | 190020 | |
| 66 | S.M. Kirov Military Medical Academy, MoD of the Russian Federation | Saint Petersburg | Russian Federation | 194044 | |
| 67 | City Multifield Hospital | Saint Petersburg | Russian Federation | 194354 | |
| 68 | Medical Research Institute, LLC | Saint Petersburg | Russian Federation | 196084 | |
| 69 | City Hospital #26 | Saint Petersburg | Russian Federation | 196247 | |
| 70 | St. Petersburg I.P. Pavlov State Medical University of Roszdrav | Saint Petersburg | Russian Federation | 197022 | |
| 71 | Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC | Voronezh | Russian Federation | 394024 | |
| 72 | Voronezh Regional Clinical Dermatovenerologic Dispensary | Voronezh | Russian Federation | 394038 | |
| 73 | Yaroslavl Regional Maternity Hospital | Yaroslavl | Russian Federation | 150003 |
Sponsors and Collaborators
- Lumara Health, Inc.
Investigators
- Study Director: Jim Joffrion, Lumara Health, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lumara Health, Inc.
ClinicalTrials.gov Identifier:
NCT00694928
Other Study ID Numbers:
- CBC-303-603-622467
First Posted:
Jun 11, 2008
Last Update Posted:
Mar 5, 2012
Last Verified:
Feb 1, 2012
Additional relevant MeSH terms: