Vaginal InfectionPhase 3NCT00694928
Vaginal Infection Study 2
A Phase 3 study testing clindamycin phosphate/butoconazole nitrate and butoconazole nitrate in people with Vaginal Infection, run by Lumara Health, Inc. at 73 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Vaginal Infection
- What is being tested?
- clindamycin phosphate/butoconazole nitrate and butoconazole nitrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 843 participants
- Where
- 73 sitesin 3 countries
- Study dates
- May 2008to Nov 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
73 sites in 3 countries.
73 sites in 3 countries
United States43 sites
Steven Z. Lenowitz, MD, LLC
Bel Air, Maryland, 21014
Brookwood Ob-GYN, PC/Women's Medical Plaza
Birmingham, Alabama, 35209
The Woman's Clinic
Boise, Idaho, 83712
Taylor/Wade Medical
Bountiful, Utah, 84010
Triangle Ob/Gyn
Cary, North Carolina, 27518
Creekside Women's Care
Charleston, South Carolina, 29414
The Family Healthcare Center, PA
Clinton, South Carolina, 29325
Total Women's Health and Wellness
Decatur, Georgia, 30030
Dekalb Gynecology Associates
Decatur, Georgia, 30035
Pacific Women's Center, LLC/Clinical Trials of America
Eugene, Oregon, 97401
Kaner Medical Group, PA
Euless, Texas, 76039
Women's Wellness Center
Fayetteville, North Carolina, 28304
Holzer Clinic
Gallipolis, Ohio, 45631
Meridian Clinical Research, LLC
Greensboro, North Carolina, 27455
Greenville Pharmaceutical Research
Greenville, South Carolina, 29615
SHE Medical Center
Hartford, Connecticut, 06105
Ob/Gyn Associates
Jonesboro, Arkansas, 72401
Red Rocks OB/GYN
Lakewood, Colorado, 80228
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, 19446
Debra Hemsath, MD
Largo, Florida, 33774
Lawrence Ob/Gyn Associates
Lawrenceville, New Jersey, 08648
Women's Health Research Center, LLC
Lawrenceville, New Jersey, 08648
The Woman's Clinic, PA
Little Rock, Arkansas, 72205
Peak Health Medical Group
Los Angeles, California, 90025
Advanced Reserch Associates
McAllen, Texas, 78505
Gynecology and Obstetrics
Memphis, Tennessee, 38120
Mid-South Ob/Gyn
Memphis, Tennessee, 38120
International Research Associates
Miami, Florida, 33156
Drug Research Analysis Corp
Montgomery, Alabama, 36106
Drug Research and Analysis Corp.
Montgomery, Alabama, 36106
Lynn Institute of Norman
Norman, Oklahoma, 73069
James T. Martin, Jr., MD, Ob/Gyn
North Charleston, South Carolina, 29406
Suncoast Clinical Research
Palm Harbor, Florida, 34684
University Clinical Research
Pines, Florida, 33024
Willowbend Health & Wellness
Plano, Texas, 75093
New Millennium Ob/Gyn
Riverdale, Georgia, 30274
Women's Health Care at Frost Street
San Diego, California, 30035
Tidewater Clinical Research
Virginia Beach, Virginia, 23456
Family Practice Center of Wadsworth, Inc
Wadsworth, Ohio, 44281
Brown Clinical, PLLP
Watertown, South Dakota, 57201
The Iowa Clinic Department of Ob/Gyn
West Des Moines, Iowa, 50266
Steven Freedman, MD, Inc.
West Hills, California, 91307
Vermont Urogynecology Associates, PC
Williston, Vermont, 05495
Russia20 sites
Medical University Clinic
Kazan', 420012
Clinical Dermatovenerologic Dispensary
Krasnodar, 350020
State Dermatovenerology Research Center of the Federal Agency for Provision of High Technology Medical Aid
Moscow, 107076
State Health Care Institution Moscow City Clinical Hospital #12
Moscow, 115516
Russian Medical Academy of Postgraduate Studies of Roszdrav
Moscow, 123995
State Healthcare Institution Moscow Clinical Hospital #68
Moscow, 127473
Novisibirsk Municipal Dermatovenerologic Dispensary #1
Novosibirsk, 630082
State Health Care Institution Orenburg Regional Clinical Hospital #2
Orenburg, 460000
Republican Dermatovenerologic Dispensary, MoH of Karelia Republic
Petrozavodsk, 185002
Maximillian City Hospital #28
Saint Petersburg, 190000
State Healthcare Institution Regional Dermatovenerologic Dispensary
Saint Petersburg, 190020
S.M. Kirov Military Medical Academy, MoD of the Russian Federation
Saint Petersburg, 194044
City Multifield Hospital
Saint Petersburg, 194354
Medical Research Institute, LLC
Saint Petersburg, 196084
City Hospital #26
Saint Petersburg, 196247
St. Petersburg I.P. Pavlov State Medical University of Roszdrav
Saint Petersburg, 197022
Kurortniy Ward City Hospital #40
Sestroretsk, Sankt-Peterburg, 197706
Railway Clinic Hospital of the Voronezh-,1 Railway Station, RJD JSC
Voronezh, 394024
Voronezh Regional Clinical Dermatovenerologic Dispensary
Voronezh, 394038
Yaroslavl Regional Maternity Hospital
Yaroslavl, 150003
India10 sites
Mayani Hosptial and Research Centre
Ajmer, Rajasthan, 305001
Bangalore Diabetes Centre
Bangalore, Karnataka, 560043
Care Hospital
Hyderabad, 500034
Sharda Hospital
Jaipur, Rajasthan, 302020
Shri Krishna Hospital
Jaipur, 302001
MV Hospital and Research Centre
Lucknow, Uttar Pradesh, 226003
AJ Medical College and Hospital
Mangalore, Karnataka, 575004
Mediciti Institute of Medical Sciences
Ranga Reddy District, 501401
Krishna Institute of Medical Sciences
Secunderabad, 500003
King George Hospital
Visakhapatnam, 530002
About this study
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.
- Conditions
- Vaginal Infection
- Being tested
- clindamycin phosphate/butoconazole nitrate, butoconazole nitrate
- Medical subject headings
- 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
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 | 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 posted11 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal InfectionStudies 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
- 843 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
- NCT00694928
- Sponsor's protocol ID
- CBC-303-603-622467
- Status last verified
- Feb 2012
- First submitted
- 9 Jun 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 2
- ClinicalTrials.gov ID
- NCT00694928
- Acronym / sponsor ID
- CBC-303-603-622467
- Conditions
- Vaginal Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- Lumara Health, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 11 Jun 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 another vaginal product 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
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: clindamycin phosphate/butoconazole nitrateclindamycin phosphate/butoconazole nitrate |
| 2 | 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 |
| butoconazole nitratesemi-solid, single dose | Drug | 2 |
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 Vaginal Infection
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
RecruitingObservational study
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Not yet recruitingPhase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
RecruitingObservational study
Large Algorithm Setting and Validation Study
Bacterial Infections, Bacterial Infections and Mycoses
Not yet recruitingPhase 1
A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women
Bacterial Vaginosis
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.
73 sites in 3 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 and butoconazole nitrate in people with Vaginal Infection, run by Lumara Health, Inc. at 73 sites in 3 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 73 sites in United States, Russia, India. 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; AzTrials last refreshed its copy on 29 Oct 2026.