Vaginosis, BacterialPhase 4NCT02392026
Safety and Tolerability of Metronidazole Gel 1.3%
A Phase 4 study testing Metronidazole Gel in people with Vaginosis, Bacterial, run by Insud Pharma at 8 sites in United States.
Trial summary
Multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel in females 12 to <18 years for the treatment of bacterial vaginosis. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women only
- Conditions the study is for
- Vaginosis, Bacterial
- What is being tested?
- Metronidazole Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesUnited States
- Study dates
- 12 Aug 2015to 5 Oct 2016
- Phase
- Phase 4
- 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 12 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Provide written assent and parent/legal guardian informed consent and authorization to disclose protected health information.
- Post-menarcheal, adolescent female, 12 to <18 years of age at time of Screening/Baseline Visit (Day 1).
- In good general health at Screening visit with no known medical conditions that, in the Investigator's opinion, may interfere with study participation.
- Has negative urine pregnancy test result prior to study treatment initiation.
- Has clinical diagnosis of bacterial vaginosis.
- Agree to abstain from sexual intravaginal intercourse for study duration.
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- Willing to avoid alcohol ingestion for 24 hours after administration of test article.
- Agree to refrain from use of intravaginal products for duration of study (e.g. lubricated condoms, tampons, diaphragms, spermicides, feminine deodorant sprays, douches). Intravaginal Uterine Device (IUD) use is acceptable as long as it has been in place for 30 days prior to study enrollment.
- Willing and able to participate in study, make required visits to the study center, and comply with all study requirements including concomitant medication and other treatment restrictions.
Who cannot join
- Pregnant, lactating, or planning to become pregnant during study period.
- Currently menstruating or anticipate onset of menses during first 9 days of the study.
- Experience a clinically important medical event with 90 days of Screening/Baseline Visit (Day 1).
- Evidence of other infectious causes of vulvovaginal infection or condition that in the Investigator's opinion would confound the interpretation of the study results.
- Severe symptoms of dysuria and/or pruritus, burning or irritation in vulvovaginal area.
- Received systemic or intravaginal antifungal, antibacterial or antiparasitic drugs within 14 days of Screening/Baseline visit (Day 1). Antiviral therapies (non-intravaginal) are acceptable.
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- Has taken disulfiram or systemic corticosteroids (oral or injected) within 14 days of Screening/Baseline Visit (Day 1).
- Had sexual intravaginal intercourse within 24 hours of Screening/Baseline (Day 1).
- Demonstrated previous hypersensitivity to metronidazole, either orally or topically administered, or any form of parabens or benzyl alcohol.
- Known primary or secondary immunodeficiency condition/syndrome.
- Being treated or planning to be treated during the study period for cervical intraepithelial neoplasia (CIN) or cervical carcinoma.
- Using anticoagulation therapy with Coumadin (warfarin).
- Previously treated with test article under this protocol.
- Participate in an experimental drug/device trial within the last 30 days before Screening/Baseline Visit (Day 1).
- Is judged by the Investigator to be unsuitable for any reason.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Allergan Research Site #315
Bardstown, Kentucky, 40004
Allergan Research Site #319
Columbus, Ohio, 43231
Allergan Research Site #322
Dayton, Ohio, 45406
Allergan Research Site #316
Irving, Texas, 75062
Allergan Research Site #318
Long Beach, California, 90806
Allergan Research Site #321
Memphis, Tennessee, 38104
Allergan Research Site #314
New Orleans, Louisiana, 70115
Allergan Research Site #324
Paramount, California, 90723
About this study
Official title: A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Metronidazole Vaginal Gel 1.3% in Adolescent Female Subjects With Bacterial Vaginosis
Multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel in females 12 to <18 years for the treatment of bacterial vaginosis.
Read the detailed description
A multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel 1.3% when administered as a single dose in adolescent females (aged 12 to <18 years) for the treatment of bacterial vaginosis.
- Conditions
- Vaginosis, Bacterial
- Being tested
- Metronidazole Gel
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole GelDrug
Also called Metro Gel
Metronidazole Vaginal Gel 1.3% administered via applicator
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole Gel | Experimental | Metronidazole Vaginal Gel Receives: Drug: Metronidazole Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with treatment-emergent adverse events (AEs), serious AEs, treatment-related AEs and AEs leading to study discontinuation after Metronidazole Vaginal Gel is administered in post-menarcheal, adolescent females with bacterial vaginosis.
No serious AEs reported during the completed study
Measured: up to 10 days
A multicenter open label to evaluate safety and tolerability of metronidazole vaginal gel 1.3% for adolescents female subject with bacterial and vaginosis
Metronidazole Vaginal Gel 1.3% is safe, well tolerated, and efficacious in treating vaginal discharge and odor in adolescent females aged 12 to < 18 years with bacterial vaginosis. The safety and efficacy profiles in this study were consistent with the known safety and efficacy profiles for the adult population and no new safety concerns were identified.
Measured: up tp 10 days
Secondary outcomes (1)
Number of subjects reporting presence of daily vaginal discharge and/or odor following single dose administration of Metronidazole Vaginal Gel 1.3%assessment of the presence of vaginal discharge and odor following single dose administration.
no order or smelling observed
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start12 Aug 2015
- Primary completion5 Oct 2016
- Study completion5 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginosis, BacterialStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insud Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allergan Sales, LLC
- Responsible party
- Sponsor
- Investigators
- Gina Giannantoni-Ibelli, MS, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392026
- Sponsor's protocol ID
- MG1401
- Status last verified
- Aug 2023
- First submitted
- 4 Mar 2015
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Metronidazole Vaginal Gel 1.3% in Adolescent Female Subjects With Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT02392026
- Acronym / sponsor ID
- MG1401
- Conditions
- Vaginosis, Bacterial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Insud PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Allergan Sales, LLC
- Study start
- 12 Aug 2015 (actual)
- Primary completion
- 5 Oct 2016 (actual)
- Study completion
- 5 Oct 2016 (actual)
- First posted
- 18 Mar 2015 (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.
Multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel in females 12 to <18 years for the treatment of bacterial vaginosis.
Detailed description
A multicenter, open-label study to evaluate safety and tolerability of Metronidazole Vaginal Gel 1.3% when administered as a single dose in adolescent females (aged 12 to <18 years) for the treatment of bacterial vaginosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metronidazole Gel | Experimental | Drug: Metronidazole GelMetronidazole Vaginal Gel |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Provide written assent and parent/legal guardian informed consent and authorization to disclose protected health information.
- Post-menarcheal, adolescent female, 12 to <18 years of age at time of Screening/Baseline Visit (Day 1).
- In good general health at Screening visit with no known medical conditions that, in the Investigator's opinion, may interfere with study participation.
- Has negative urine pregnancy test result prior to study treatment initiation.
- Has clinical diagnosis of bacterial vaginosis.
Key exclusion criteria (15 listed)
- Pregnant, lactating, or planning to become pregnant during study period.
- Currently menstruating or anticipate onset of menses during first 9 days of the study.
- Experience a clinically important medical event with 90 days of Screening/Baseline Visit (Day 1).
- Evidence of other infectious causes of vulvovaginal infection or condition that in the Investigator's opinion would confound the interpretation of the study results.
- Severe symptoms of dysuria and/or pruritus, burning or irritation in vulvovaginal area.
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 GelAlso: Metro GelMetronidazole Vaginal Gel 1.3% administered via applicator | Drug | Metronidazole Gel |
Primary outcome
Number of subjects with treatment-emergent adverse events (AEs), serious AEs, treatment-related AEs and AEs leading to study discontinuation after Metronidazole Vaginal Gel is administered in post-menarcheal, adolescent females with bacterial vaginosis.
Time frame: up to 10 days
No serious AEs reported during the completed study
A multicenter open label to evaluate safety and tolerability of metronidazole vaginal gel 1.3% for adolescents female subject with bacterial and vaginosis
Time frame: up tp 10 days
Metronidazole Vaginal Gel 1.3% is safe, well tolerated, and efficacious in treating vaginal discharge and odor in adolescent females aged 12 to < 18 years with bacterial vaginosis. The safety and efficacy profiles in this study were consistent with the known safety and efficacy profiles for the adult population and no new safety concerns were identified.
1 secondary outcome
Number of subjects reporting presence of daily vaginal discharge and/or odor following single dose administration of Metronidazole Vaginal Gel 1.3%assessment of the presence of vaginal discharge and odor following single dose administration.
Time frame: up to 10 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 15 Aug 2023.
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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.
Gina Giannantoni-Ibelli, MS study director
Allergan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole Gel in people with Vaginosis, Bacterial, run by Insud Pharma at 8 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 9 inclusion and 15 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 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of subjects with treatment-emergent adverse events (AEs), serious AEs, treatment-related AEs and AEs leading to study discontinuation after Metronidazole Vaginal Gel is administered in post-menarcheal, adolescent females with bacterial vaginosis. (time frame: up to 10 days). The study lists 2 primary outcomes in all. 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 15 Aug 2023.