Vaginal InfectionPhase 3SMART GIVESNCT02308046
Multi-Center Study of New Medications to Treat Vaginal Infections
A Phase 3 study testing Terconazole in people with Vaginal Infection, run by Curatek Pharmaceuticals, LLC at 41 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the treatment of vaginal infections Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Vaginal Infection
- What is being tested?
- Terconazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 41 sitesUnited States
- Study dates
- Jun 2015to Jun 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:
- Capable of providing written informed consent or assent
- Currently not menstruating and not anticipating menses during treatment
- If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control
- Negative pregnancy test
- Other criteria as identified in the protocol
Who cannot join
- Other infectious causes of vulvovaginitis
- Subject has recently used, or is expected to require the concomitant use of prohibited medications/products
- Nursing mother
- Use of any investigational drug within 30 days of enrollment
- History of hypersensitivity to any ingredient/component of the formulations
- Other criteria as identified in the protocol
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Georgia Regents University
Augusta, Georgia, 30912
University of Alabama
Birmingham, Alabama, 35294
Women's Health CT Ob/Gyn
Bridgeport, Connecticut, 06606
Women's Health Practice
Champaign, Illinois, 61802
New Horizons Clinical Trials
Chandler, Arizona, 85224
Radiant Research
Columbus, Ohio, 43212
Multicare Women's Center Covington
Covington, Washington, 98042
Discovery Clinical Trials
Dallas, Texas, 75231
Downtown Women's Health Care
Denver, Colorado, 80209
HWC Women's Research Center
Englewood, Ohio, 45322
KO Clinical Research, LLC
Fort Lauderdale, Florida, 33316
TMC Life Research, Inc.
Houston, Texas, 77054
Rosemark Womens Care Specialists
Idaho Falls, Idaho, 83404
The Jackson Clinic
Jackson, Tennessee, 38305
NEA Baptist Clinic
Jonesboro, Arkansas, 72401
Women's Healthcare Specialists, PC
Kalamazoo, Michigan, 49009
Gossmont Center for Clinical Research
La Mesa, California, 91942
Red Rocks Ob/Gyn
Lakewood, Colorado, 80228
Legacy Women's Health
Las Vegas, Nevada, 89123
R. Garn Mabey Jr., MD Gynecology
Las Vegas, Nevada, 89128
Lawrence Ob/Gyn Clinical Research LLC
Lawrenceville, New Jersey, 08648
Women's Clinic of Lincoln
Lincoln, Nebraska, 68510
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, 70072
Southern Clinical Research Associates
Metairie, Louisiana, 70001
East Carolina Women's Center
New Bern, North Carolina, 28562
James T. Martin, MD
North Charleston, South Carolina, 29406
Segal Institute for Clinical Research
North Miami, Florida, 33161
Drexel University
Philadelphia, Pennsylvania, 19102
Philapelphia Clinical Research, LLC
Philadelphia, Pennsylvania, 19114
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Women's Health Research Center
Plainsboro, New Jersey, 08536
Discovery Clinical Research
Plantation, Florida, 33324
Suffolk OB/GYN
Port Jefferson, New York, 11777
Wake Research Associates
Raleigh, North Carolina, 27612
Atlanta North Gynecology
Roswell, Georgia, 30075
Genesis Center for Clinical Research
San Diego, California, 92103
Medical Center for Clinical Research
San Diego, California, 92108
Mount Vernon CLinical Research
Sandy Springs, Georgia, 30328
MomDoc Womens Health Research
Scottsdale, Arizona, 85251
Women's Clinical Research Center
Seattle, Washington, 98105
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety
The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the treatment of vaginal infections
- Conditions
- Vaginal Infection
- Being tested
- Terconazole, Placebo
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerconazoleDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Terconazole vaginal gel | Active comparator | One applicator full at bedtime Receives: Drug: Terconazole |
| Gel vehicle | Placebo comparator | One applicator full at bedtime Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit
The percentage of participants with clinical cure in each arm was compared. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis
Measured: 7-14 days after beginning treatment
Secondary outcomes (4)
Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection
Signs (edema, erythema, excoriation) and symptoms (itching, burning irritation) were each scored as absent (0), mild (1), moderate (2) or severe (3). A total sign score of 0-9 and total symptom score of 0-9 were combined for a total possible combined sign and symptom score of 0-18. Total median combined sign and symptom severity score was compared between arms at the test of cure visit. Lower scores at day 7-14 indicate improvement.
Measured: 7-14 days after beginning treatment
Mycologic Cure
Vaginal swabs were cultured for Candida species in a laboratory. A positive culture indicates presence of vaginal yeast and a negative culture indicates absence of vaginal yeast. A negative culture indicates mycologic cure.
Measured: 7-14 days after beginning treatment and at 21-30 days after beginning treatment
Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit
Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.
Measured: 7-14 days after beginning treatment
Number of Participants With Treatment Emergent Adverse Events
Adverse events were collected at study visits, from subject diaries and from spontaneous reports
Measured: Any time during study participation (up 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 posted4 Dec 2014 (estimated)
- Study startJun 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curatek Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert J Borgman, Ph.D., Study director, Curatek Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308046
- Sponsor's protocol ID
- MTC-001 (Trial 1)
- Acronym
- SMART GIVES
- Status last verified
- Jul 2020
- First submitted
- 1 Dec 2014
- Last updated
- 27 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solubilized Metronidazole And/oR Terconazole Gels Intra-Vaginal Efficacy and Safety
- ClinicalTrials.gov ID
- NCT02308046
- Acronym / sponsor ID
- SMART GIVES / MTC-001 (Trial 1)
- Conditions
- Vaginal Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Curatek Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Posted 27 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the treatment of vaginal infections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terconazole vaginal gel | Active comparator | Drug: TerconazoleOne applicator full at bedtime |
| Gel vehicle | Placebo comparator | Drug: PlaceboOne applicator full at bedtime |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:
- Capable of providing written informed consent or assent
- Currently not menstruating and not anticipating menses during treatment
- If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control
- Negative pregnancy test
Key exclusion criteria (6 listed)
- Other infectious causes of vulvovaginitis
- Subject has recently used, or is expected to require the concomitant use of prohibited medications/products
- Nursing mother
- Use of any investigational drug within 30 days of enrollment
- History of hypersensitivity to any ingredient/component of the formulations
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 |
|---|---|---|
| Terconazole | Drug | Terconazole vaginal gel |
| Placebo | Drug | Gel vehicle |
Primary outcome
Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit
Time frame: 7-14 days after beginning treatment
The percentage of participants with clinical cure in each arm was compared. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis
4 secondary outcomes
Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection
Time frame: 7-14 days after beginning treatment
Mycologic Cure
Time frame: 7-14 days after beginning treatment and at 21-30 days after beginning treatment
Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit
Time frame: 7-14 days after beginning treatment
Number of Participants With Treatment Emergent Adverse Events
Time frame: Any time during study participation (up to 30 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Randomized, Open-label
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.
Robert J Borgman, Ph.D. study director
Curatek Pharmaceuticals
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Terconazole in people with Vaginal Infection, run by Curatek Pharmaceuticals, LLC at 41 sites in United States.
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 6 inclusion and 6 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 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 27 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Cure as Assessed by the Investigator at the Test-of-cure Visit (time frame: 7-14 days after beginning treatment). 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 27 Jul 2020.