Vaginal InfectionPhase 3SMART GIVESNCT02308033

Multi-Center Study of New Medications to Treat Vaginal Infections

A Phase 3 study testing Metronidazole in people with Vaginal Infection, run by Curatek Pharmaceuticals, LLC at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and efficacy of metronidazole 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?: Metronidazole
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 204 participants
Where: 35 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

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 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
Radiant Research
Columbus, Ohio, 43212
Downtown Women's Health Care
Denver, Colorado, 80209
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
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
Harborview Medical Center
Seattle, Washington, 98104
Women's Clinical Research Center
Seattle, Washington, 98105
Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

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 metronidazole gel in the treatment of vaginal infections.

Conditions: Vaginal Infection
Being tested: Metronidazole, Gel vehicle
Medical subject headings: Vaginitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetronidazoleDrug
Gel vehicleDrug

Study groups in NCT02308033
Study group	Role	What they receive
Metronidazole vaginal gel	Active comparator	One applicator full at bedtime Receives: Drug: Metronidazole
Gel vehicle	Placebo comparator	One applicator full at bedtime Receives: Drug: Gel vehicle

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. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is <20% clue cells
Measured: 7-14 days after beginning treatment

Secondary outcomes (4)

Improvement of BV Clue Cells
Clue cells on wet mount were assessed and categorized as absent (<20%) or present (>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (<20%).
Measured: 7-14 days after beginning treatment
Microbiologic Improvement/Cure
For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments.
Measured: 7-14 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.

Jun 2015Jun 2017

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: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02308033
Sponsor's protocol ID: MTC-001 (Trial 2)
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
Safety Study of MucoCept-CVN
HIV -1 Infection
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label

All Vaginal Infection trials

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: NCT02308033
Acronym / sponsor ID: SMART GIVES / MTC-001 (Trial 2)
Conditions: Vaginal Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 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 metronidazole 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
Metronidazole vaginal gel	Active comparator	Drug: MetronidazoleOne applicator full at bedtime
Gel vehicle	Placebo comparator	Drug: Gel vehicleOne 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
Metronidazole	Drug	Metronidazole vaginal gel
Gel vehicle	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. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine "fishy" odor, 3. the saline wet mount is <20% clue cells

4 secondary outcomes

Improvement of BV Clue Cells
Time frame: 7-14 days after beginning treatment
Microbiologic Improvement/Cure
Time frame: 7-14 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

Results posted to the registry on 27 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metronidazole Vaginal Gel	102	76
Gel Vehicle	102	83

Primary outcome: Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit

Time frame: 7-14 days after beginning treatment. Count of participants. Unit: Participants

Measure	Metronidazole Vaginal Gel n = 76	Gel Vehicle n = 83
Value	47	18

Metronidazole Vaginal Gel vs Gel Vehicle: p <0.001, Chi-squared, Corrected

Population analysed: mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over the entire course of the study (up to 30 days after beginning treatment).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metronidazole Vaginal Gel	0 of 96 (0%)	25 of 96 (26%)	0 of 96
Gel Vehicle	0 of 97 (0%)	10 of 97 (10.3%)	0 of 97

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

Related trials for Vaginal Infection

Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
Safety Study of MucoCept-CVN
HIV -1 Infection
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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

35 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 Metronidazole in people with Vaginal Infection, run by Curatek Pharmaceuticals, LLC at 35 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 35 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?

On the ClinicalTrials.gov record for NCT02308033.

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.