Bacterial VaginosisPhase 3NCT00741845
Prevention of Persistence of Bacterial Vaginosis
A Phase 3 study testing intravaginal metronidazole in people with Bacterial Vaginosis, run by Embil Pharmaceutical Co. Ltd at 1 site in Peru.
Trial summary
This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg)… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- intravaginal metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 sitePeru
- Study dates
- Jun 2008to Jun 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women 18-40 yrs old
- abnormal vaginal discharge or malodor
- positive QuickVue test
- positive KOH whiff test
- Positive finding of clue cells greater than or equal to 20% on wet mount
- Able to give informed consent
- willing to abstain from alcohol during the 5 day therapy and 1 day following
Who cannot join
- immunocompromised women
- symptomatic VVC
- pregnancy or positive pregnancy test
- menstruating or breastfeeding women
- other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks
- women with MPC, PID
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Persistence of Bacterial Vaginosis: The Effects of High Dose Intravaginal Metronidazole
This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent bacterial vaginosis.
- Conditions
- Bacterial Vaginosis
- Being tested
- intravaginal metronidazole
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravaginal metronidazoleDrug
high dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | intravaginal metronidazole 750mg + 200mg miconazole Receives: Drug: intravaginal metronidazole |
| 2 | Active comparator | intravaginal metronidazole 750mg Receives: Drug: intravaginal metronidazole |
| 3 | Active comparator | intravaginal metronidazole 37.5mg Receives: Drug: intravaginal metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The specific aim of this study is to compare the rate of persistence of BV in non-pregnant women randomized to one of three different schemes of intravaginal metronidazole given nightly for 5 nights
Measured: 28 days after therapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009
Why it stopped: Terminated for site documentation and monitoring issues - not safety, study drug, or adverse event issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Embil Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741845
- Sponsor's protocol ID
- Embil-2008Peru
- Status last verified
- Mar 2012
- First submitted
- 25 Aug 2008
- Last updated
- 6 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Persistence of Bacterial Vaginosis: The Effects of High Dose Intravaginal Metronidazole
- ClinicalTrials.gov ID
- NCT00741845
- Acronym / sponsor ID
- Embil-2008Peru
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated for site documentation and monitoring issues - not safety, study drug, or adverse event issues.
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Embil Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- First posted
- 26 Aug 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 purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent bacterial vaginosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: intravaginal metronidazoleintravaginal metronidazole 750mg + 200mg miconazole |
| 2 | Active comparator | Drug: intravaginal metronidazoleintravaginal metronidazole 750mg |
| 3 | Active comparator | Drug: intravaginal metronidazoleintravaginal metronidazole 37.5mg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- women 18-40 yrs old
- abnormal vaginal discharge or malodor
- positive QuickVue test
- positive KOH whiff test
- Positive finding of clue cells greater than or equal to 20% on wet mount
Key exclusion criteria (6 listed)
- immunocompromised women
- symptomatic VVC
- pregnancy or positive pregnancy test
- menstruating or breastfeeding women
- other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks
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 |
|---|---|---|
| intravaginal metronidazolehigh dose intravaginal metronidazole 750mg (with or without miconazole) to be compared to low dose intravaginal metronidazole 37.5mg | Drug | 1, 2, 3 |
Primary outcome
The specific aim of this study is to compare the rate of persistence of BV in non-pregnant women randomized to one of three different schemes of intravaginal metronidazole given nightly for 5 nights
Time frame: 28 days after therapy initiation
Results and safety
The study was stopped early (reason given: Terminated for site documentation and monitoring issues - not safety, study drug, or adverse event issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intravaginal metronidazole in people with Bacterial Vaginosis, run by Embil Pharmaceutical Co. Ltd at 1 site in Peru.
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 7 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: stopped early, as of the sponsor's last update on 6 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 1 site in Peru. 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 was stopped early (reason given: Terminated for site documentation and monitoring issues - not safety, study drug, or adverse event issues.). Results are not available in the source record.
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?
The specific aim of this study is to compare the rate of persistence of BV in non-pregnant women randomized to one of three different schemes of intravaginal metronidazole given nightly for 5 nights (time frame: 28 days after therapy initiation). 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 6 Mar 2012; AzTrials last refreshed its copy on 7 Nov 2026.