Vaginosis, BacterialPhase 3NCT01293643
A Study to Compare the Efficacy and Safety of a Combination of Ketoconazole and Clindamycin Compared to Tetracycline/Amphotericin B Combination Cream for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis (P08077)
A Phase 3 study testing 100 mg clindamycin /800 mg ketoconazole vaginal ovule and 100 mg tetracycline hydrochloride /50 mg amphotericin B cream in people with Vaginosis, Bacterial and Candidiasis, Vulvovaginal, run by Merck Sharp & Dohme LLC.
Trial summary
This is a study to compare the safety and efficacy of the use of a intravaginal ovule containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream containing a combination Tetracycline and Amphotericin B for the treatment of bacterial vaginosis and/or mixed or isolated vaginal… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vaginosis, Bacterial, Candidiasis, Vulvovaginal
- What is being tested?
- 100 mg clindamycin /800 mg ketoconazole vaginal ovule and 100 mg tetracycline hydrochloride /50 mg amphotericin B cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Jan 2011
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of vaginal candidiasis
- No Trichomonas vaginalis or any other protozoa
- No clinical evidences of infection by Neisseria gonorrhoeae, Chlamydia trachomatis, or viral infections
Who cannot join
- Known sensitivity to the formula components
- Pregnant or nursing patients
- Any gynecological condition contraindicating the use of vaginal ovule or cream.
- Use of any other local or systemic bactericidal, anti-protozoa or antifungal agent within the 2 weeks prior to the study start or during it
- Presence of other sexually transmitted diseases (except from Candidal vaginitis).
- History of recurrent candidiasis (≥4 episodes per year)
Show all 9Show fewer
- Use of intra-uterine device, spermicides, or diaphragms
- Has metabolic or immune disorder
- Has abnormal uterine bleeding
About this study
Official title: A Phase 3b, Comparative and Randomized Study to Assess the Efficacy and Safety of an Intravaginal Ovule Combination of Ketoconazole and Clindamycin Compared With an Intravaginal Cream Combination of Tetracycline and Amphotericin B for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis, Either Mixed or Isolated
This is a study to compare the safety and efficacy of the use of a intravaginal ovule containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream containing a combination Tetracycline and Amphotericin B for the treatment of bacterial vaginosis and/or mixed or isolated vaginal candidiasis.
- Conditions
- Vaginosis, Bacterial, Candidiasis, Vulvovaginal
- Being tested
- 100 mg clindamycin /800 mg ketoconazole vaginal ovule, 100 mg tetracycline hydrochloride /50 mg amphotericin B cream
- Medical subject headings
- Vaginosis, Bacterial, Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 mg clindamycin /800 mg ketoconazole vaginal ovuleDrug
1 vaginal ovule for 3 consecutive days
100 mg tetracycline hydrochloride /50 mg amphotericin B creamDrug
1 applicator (4 g) full of cream intravaginally for 7 to 10 days
| Study group | Role | What they receive |
|---|---|---|
| clindamycin/ketoconazole combination | Experimental | Not described Receives: Drug: 100 mg clindamycin /800 mg ketoconazole vaginal ovule |
| tetracycline hydrochloride/amphotericin B combination | Active comparator | Not described Receives: Drug: 100 mg tetracycline hydrochloride /50 mg amphotericin B cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants that obtain clinical cure
Measured: Baseline up to Day 10
Percentage of participants that obtain microbiological cure
Measured: Baseline up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startMay 2010
- Primary completionJan 2011
- Study completionJan 2011
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.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293643
- Sponsor's protocol ID
- P08077
- Other IDs
- BR 001-09
- Status last verified
- Aug 2015
- First submitted
- 9 Feb 2011
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Comparative and Randomized Study to Assess the Efficacy and Safety of an Intravaginal Ovule Combination of Ketoconazole and Clindamycin Compared With an Intravaginal Cream Combination of Tetracycline and Amphotericin B for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis, Either Mixed or Isolated
- ClinicalTrials.gov ID
- NCT01293643
- Acronym / sponsor ID
- P08077
- Conditions
- Vaginosis, Bacterial, Candidiasis, Vulvovaginal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Feb 2011 (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 is a study to compare the safety and efficacy of the use of a intravaginal ovule containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream containing a combination Tetracycline and Amphotericin B for the treatment of bacterial vaginosis and/or mixed or isolated vaginal candidiasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clindamycin/ketoconazole combination | Experimental | Drug: 100 mg clindamycin /800 mg ketoconazole vaginal ovule |
| tetracycline hydrochloride/amphotericin B combination | Active comparator | Drug: 100 mg tetracycline hydrochloride /50 mg amphotericin B cream |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of vaginal candidiasis
- No Trichomonas vaginalis or any other protozoa
- No clinical evidences of infection by Neisseria gonorrhoeae, Chlamydia trachomatis, or viral infections
Key exclusion criteria (9 listed)
- Known sensitivity to the formula components
- Pregnant or nursing patients
- Any gynecological condition contraindicating the use of vaginal ovule or cream.
- Use of any other local or systemic bactericidal, anti-protozoa or antifungal agent within the 2 weeks prior to the study start or during it
- Presence of other sexually transmitted diseases (except from Candidal vaginitis).
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 |
|---|---|---|
| 100 mg clindamycin /800 mg ketoconazole vaginal ovule1 vaginal ovule for 3 consecutive days | Drug | clindamycin/ketoconazole combination |
| 100 mg tetracycline hydrochloride /50 mg amphotericin B cream1 applicator (4 g) full of cream intravaginally for 7 to 10 days | Drug | tetracycline hydrochloride/amphotericin B combination |
Primary outcome
Percentage of participants that obtain clinical cure
Time frame: Baseline up to Day 10
Percentage of participants that obtain microbiological cure
Time frame: Baseline up to Day 10
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 10 Aug 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 100 mg clindamycin /800 mg ketoconazole vaginal ovule and 100 mg tetracycline hydrochloride /50 mg amphotericin B cream in people with Vaginosis, Bacterial and Candidiasis, Vulvovaginal, run by Merck Sharp & Dohme LLC.
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 3 inclusion and 9 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 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of participants that obtain clinical cure (time frame: Baseline up to Day 10). 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 10 Aug 2015.