VulvovaginitisPhase 3NCT00616330
Vaginal Infection Study
A Phase 3 study testing clindamycin phosphate/butoconazole nitrate, clindamycin phosphate and butoconazole nitrate in people with Vulvovaginitis and Vaginitis, run by Lumara Health, Inc. at 133 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Vulvovaginitis, Vaginitis
- What is being tested?
- clindamycin phosphate/butoconazole nitrate, clindamycin phosphate and butoconazole nitrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,443 participants
- Where
- 133 sitesin 4 countries
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have a clinical diagnosis of vaginal infection.
- Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.
Who cannot join
- 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.
Trial locations and contacts
133 sites in 4 countries.
133 sites in 4 countries
United States81 sites
Atlanta Medical Research Institute
Alpharetta, Georgia, 30005
Women Partners in Health
Austin, Texas, 78705
Clinical Research Consultants, Inc
Birmingham, Alabama, 35209
Jefferson Clinic, PC
Birmingham, Alabama, 35233
Mid Dakota Clinic Center for Women
Bismarck, North Dakota, 58501
AMR Research Associates
Bogart, Georgia, 30622
The Woman's Clinic
Boise, Idaho, 83712
Med Center
Carmichael, California, 95608
Womans Health Practice, LLC
Champaign, Illinois, 61820
Star W. Research
Chandler, Arizona, 85225
Eastowne OB-GYN and Infertility
Chapel Hill, North Carolina, 27514
Hyperion Clinical Research, LLC
Charleston, West Virginia, 25301
Women's Medical Research Group, LLC
Clearwater, Florida, 33759
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909
Complete Healthcare for Women
Columbus, Ohio, 43231
Advanced Research Associates
Corpus Christi, Texas, 78414
Medical Network for Educators and Research
Decatur, Georgia, 30033
Soapstone Center for Clinical Research
Decatur, Georgia, 30034
Universal Biopharma Research Institute, Inc./Alta Family Health Clinic, Inc.
Dinuba, California, 93618
Atlanta West Women's Center
Douglasville, Georgia, 30134
Research Across America
El Paso, Texas, 79902
HWC Women's Research Center
Englewood, Ohio, 45322
Choice Research, LLC
Enterprise, Alabama, 36330
Pacific Women's Center, LLC
Eugene, Oregon, 97401
New England Center for Clinical Research, Inc.
Fall River, Massachusetts, 02720
Sierra Medical Research
Fresno, California, 93611
Holzer Clinic
Gallipolis, Ohio, 45631
Associates Ob/Gyn
Germantown, Tennessee, 38138
Precision Trials, LLC/Desert West OB/GYN
Glendale, Arizona, 85304
Female Pelvic Medicine and Urogynecology Institute of Michigan
Grand Rapids, Michigan, 49506
Women's Health Care Associates, PC
Hartford, Connecticut, 06105
Activmed Practices & Research, Inc.
Haverhill, Massachusetts, 01830
Laurel Highlands Ob/Gyn, PC
Hopwood, Pennsylvania, 15445
Planned Parenthood of Houston
Houston, Texas, 77004
The Woman's Hospital of Texas Clinical Research Center
Houston, Texas, 77054
TMC Life Research, Inc
Houston, Texas, 77054
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404
Bexar Clinical Trials, LLC
Irving, Texas, 75061
NEA Women's Clinic
Jonesboro, Arkansas, 33760
Grossmont Center for Clinical Research
La Mesa, California, 91942
Red Rocks OB/GYN
Lakewood, Colorado, 80228
Tanner Clinic
Layton, Utah, 84041
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas, 72204
The Woman's Clinic, P.A.
Little Rock, Arkansas, 72205
Clinical Trials Management
Mandeville, Louisiana, 70471
Medford Women's Clinic, LLP
Medford, Oregon, 97504
Women's Care Center, PLC
Memphis, Tennessee, 38119
Aurora Advanced Healthcare, Inc
Milwaukee, Wisconsin, 53209
Clinical Trials Research Services, LLC
Natrona Heights, Pennsylvania, 15065
Healthcare for Women
New Bedford, Massachusetts, 02740
Eastern Carolina Women's Center
New Bern, North Carolina, 28562
Segal Institute for Clinical Research
North Miami, Florida, 33161
Women's Health Care Specialists, PC
Paw Paw, Michigan, 49079
Women's Health Research
Phoenix, Arizona, 85015
Precision Trials LLC
Phoenix, Arizona, 85032
Willowbend Health and Wellness
Plano, Texas, 75093
Mt. Timpangos Women's Healthcare
Pleasant Grove, Utah, 84062
Suffolk Ob/Gyn
Port Jefferson, New York, 11777
Lynn Institute of Pueblo
Pueblo, Colorado, 81001
The Medical Group of Northern Nevada
Reno, Nevada, 89502
Salt Lake Research
Salt Lake City, Utah, 84107
InVisions Consultants, LLC c/o Northeast Ob/Gyn
San Antonio, Texas, 78217
San Diego Clinical Research Center
San Diego, California, 92103
Salt Lake Women's Center
Sandy City, Utah, 84070
Physician Care Clinical Research
Sarasota, Florida, 34239
Precision Clinical Research
Searcy, Arkansas, 72143
Regional Research Specialists, LLC
Shreveport, Louisiana, 71106
Northern Indiana Womens Health Research
South Bend, Indiana, 46601
Women's Health Partner
St Louis, Missouri, 63117
Consultants in Women's Healthcare
St Louis, Missouri, 63131
New Ballas OB-GYN, Inc.
St Louis, Missouri, 63141
Insignia Clinical Research
Tampa, Florida, 33607
King's Daughter Clinic
Temple, Texas, 76502
Visions Clinical Research - Tucson
Tucson, Arizona, 85712
Tidewater Clinical Research, Inc
Virginia Beach, Virginia, 23456
Walla Walla Clinic
Walla Walla, Washington, 99362
Greater Hartford Womens Association/Women's Health
West Hartford, Connecticut, 06117
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103
Valaores & Lewis Obstetrics & Gynocology
Winston-Salem, North Carolina, 27103
Preferred OB/GYN/ Women's Health
Woodbury, New York, 11797
Russia29 sites
Kaluga Regional Dermatovenerologic Dispensary
Kaluga, 24800
Dermatovenerologic Dispensary
Korolyov, Moscow Oblast, 141074
D.O. Ott Research Institute of Ob/Gyn--Family Planning and Female Health Center
Mendeleevskaya Line, Sankt-Peterburg, 199034
D.O. Ott Research Institute of Ob/Gyn--Gynecologic Endocrinology
Mendeleyevskaya, Sankt-Peterburg, 199034
Moscow Regional Research Insitute of Obstetrics and Gynecology
Moscow, 101000
Dermatovenerologic Dispensary #15
Moscow, 111538
Family Planning and Reproductive Centre
Moscow, 117152
The Peoples' Friendship University of Russia
Moscow, 117198
City Clinical Hospital #52
Moscow, 117997
City Clinical Hospital #31
Moscow, 119415
Clinic of Skin and Sexual Transmitted Diseases
Moscow, 119435
City Clinical Hospital #51
Moscow, 121309
Nizhegorodskiy Dermatovenerologic Scientific Research Institute of Federal Agency for Public Health and Human Services
Nizhny Novgorod, 603950
Regional Dermatovenerologic Dispensary
Rostov-on-Don, 344007
Ryazan Regional Clinical Dermatovenerologic Dispensary
Ryazan, 390046
Juventa--Reproductive Health
Saint Petersburg, 190020
Medical Mycology Scientific Research Institute at St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav
Saint Petersburg, 191015
442 District Military Clinical Hospital of Leningradsky Military District
Saint Petersburg, 191124
City Dermatovenerologic Dispensary
Saint Petersburg, 192102
S.M. Kirov Military Medical Academy, MoD of the Russian Federation
Saint Petersburg, 194044
L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#321
Saint Petersburg, 194291
L.G. Sokolov Clinical Hospital #122 of the Federal Medical-Biologic Agency--#322
Saint Petersburg, 194291
Leningradskiy Regional Clinical Hospital
Saint Petersburg, 194291
Family Planning and Reproductive Centre
Saint Petersburg, 195008
St. Petersburg State I.I. Mechnikov Medical Academy of Roszdrav
Saint Petersburg, 195067
Andros Clinic, LLC
Saint Petersburg, 197136
Smolensk State Medical Academy of Roszdrav
Smolensk, Smolensk Oblast, 214019
Smolensk Dermatovenerologic Dispensary
Smolensk, 214000
Orkli, LLC
V.o., Sankt-Peterburg, 199178
India22 sites
Chopra Nursing and Maternity Home
Agra, 282001
Institute of Kidney Disease and Research Centre
Ahmedabad, Gujarat, 380016
Neha Prakash Hospital
Bangalore, Karnataka, 560064
Sri Ramachandra Medical College
Chennai, Tamil Nadu, 600116
Yashoda Super Speciality Hospital
Ghaziabad, 201001
Government Maternity Hospital
Hyderabad, 500002
Government Maternity Hospital
Hyderabad, 500095
Makker Medical Center
Lucknow, 226991
Father Muller Medical College Hospital
Mangalore, Kamataka, 575002
KMC Hospital
Mangalore, Karnataka, 575001
Yenepoya Medical College and Hospital
Mangalore, Karnataka, 575018
Om Women's Hospital
Nagpur, Maharashtra, 440010
Avanti Institute of Cardiology
Nagpur, Maharashtra, 440012
Nagpur Test Tube Baby Centre
Nagpur, Maharashtra, 440022
VSG Healthcare, Dr. Ganorkar Hospital
Nashik, Maharashtra, 422001
Nivedita Hospital
Nashik, Maharashtra, 422002
M.K.W. Hospital and Research Centre
New Delhi, 110027
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004
KEM Hospital Research Centre
Pune, Maharashtra, 411011
Dr. D. Y. Patil Medical College & Hospital
Pune, Maharashtra
Sri Ramachandra Medical College
Tamil Nadu, 600116
Krishna Hospital Surgical & Maternity 201/2/3 Suryadeep Complex
Vadodara, Gujarat, 390006
About this study
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.
- Conditions
- Vulvovaginitis, Vaginitis
- Being tested
- clindamycin phosphate/butoconazole nitrate, clindamycin phosphate, butoconazole nitrate
- Medical subject headings
- Vulvovaginitis, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clindamycin phosphate/butoconazole nitrateDrug
semi solid, single dose
clindamycin phosphateDrug
semi solid, single dose
butoconazole nitrateDrug
semi solid, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | clindamycin phosphate/butoconazole nitrate Receives: Drug: clindamycin phosphate/butoconazole nitrate |
| 2 | Active comparator | clindamycin phosphate Receives: Drug: clindamycin phosphate |
| 3 | Active comparator | butoconazole nitrate Receives: Drug: butoconazole nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical symptom resolution.
Measured: baseline, 7 to 10 days and 21 to 30 days
Secondary outcomes (3)
Yeast Culture for Candida
Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response
Measured: baseline, 7 to 10 days and 21 to 30 days
Gram stain Nugent score
Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution
Measured: baseline, 7 to 10 days and 21 to 30 days
Saline wet mount for clue cells
Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution
Measured: baseline, 7 to 10 days and 21 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvovaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumara Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Joffrion, Study director, Lumara Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616330
- Sponsor's protocol ID
- CBC-302-602-622467
- Status last verified
- Feb 2012
- First submitted
- 4 Feb 2008
- Last updated
- 5 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Infection Study
- ClinicalTrials.gov ID
- NCT00616330
- Acronym / sponsor ID
- CBC-302-602-622467
- Conditions
- Vulvovaginitis, Vaginitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,443 participants (actual)
- Lead sponsor
- Lumara Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: clindamycin phosphate/butoconazole nitrateclindamycin phosphate/butoconazole nitrate |
| 2 | Active comparator | Drug: clindamycin phosphateclindamycin phosphate |
| 3 | Active comparator | Drug: butoconazole nitratebutoconazole nitrate |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have a clinical diagnosis of vaginal infection.
- Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clindamycin phosphate/butoconazole nitratesemi solid, single dose | Drug | 1 |
| clindamycin phosphatesemi solid, single dose | Drug | 2 |
| butoconazole nitratesemi solid, single dose | Drug | 3 |
Primary outcome
Clinical symptom resolution.
Time frame: baseline, 7 to 10 days and 21 to 30 days
3 secondary outcomes
Yeast Culture for Candida
Time frame: baseline, 7 to 10 days and 21 to 30 days
Gram stain Nugent score
Time frame: baseline, 7 to 10 days and 21 to 30 days
Saline wet mount for clue cells
Time frame: baseline, 7 to 10 days and 21 to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
Related trials for Vulvovaginitis
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F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
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Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Active, not recruitingObservational study
Comparative Performance of a Vaginal Yeast Test
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DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Joffrion study director
Lumara Health, Inc.
133 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clindamycin phosphate/butoconazole nitrate, clindamycin phosphate and butoconazole nitrate in people with Vulvovaginitis and Vaginitis, run by Lumara Health, Inc. at 133 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 133 sites in United States, Russia, India, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical symptom resolution. (time frame: baseline, 7 to 10 days and 21 to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2012.