Bacterial Vaginosis TreatmentPhase 2NCT03234517
Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis
A Phase 2 study testing Vaginal Clindamycin Cream and Vaginal Probiotic in people with Bacterial Vaginosis Treatment, run by Zagazig University at 1 site in Egypt.
Trial summary
Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis Treatment
- What is being tested?
- Vaginal Clindamycin Cream and Vaginal Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2016to Aug 2018
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- more than 18 years
- has recurrent Bacterial Vaginosis
Who cannot join
- pregnancy
- use of other antmicrobial
- not provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Versus Interrupted Use.of Vaginal Probiotic Plus Vaginal Clindamycin Cream for Bacterial Vaginosis a Randomized Controlled Study
Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis
Read the detailed description
Vaginal Clindamycin Cream was used initially for treatment of Bacterial Vaginosis followed by Vaginal probiotic either in cnotinous or interrupted manner, then assessment of the results of treatment at different time intervals was done.
- Conditions
- Bacterial Vaginosis Treatment
- Being tested
- Vaginal Clindamycin Cream, Vaginal Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Clindamycin CreamDrug
Also called dalacin c cream
Vaginal Clindamycin Cream
Vaginal ProbioticDrug
Also called dicoflor vaginal capsules
Vaginal Probiotic
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic | Experimental | Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days Receives: Drug: Vaginal Clindamycin Cream; Drug: Vaginal Probiotic |
| Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic | Active comparator | Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use Receives: Drug: Vaginal Clindamycin Cream; Drug: Vaginal Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
initial cure rate
number of women completely cured
Measured: 2 months
Secondary outcomes (1)
recurrence rate
number of women had recurrence
Measured: 4,6,8and12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Aug 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Vaginosis TreatmentStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, IBRAHIM ABD ELGAFOR, Zagazig University
- Investigators
- Ibrahim A EL sharkwy, Principal investigator, FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234517
- Sponsor's protocol ID
- zuh- 8
- Status last verified
- Jul 2017
- First submitted
- 26 Jul 2017
- Last updated
- 7 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Interrupted Use.of Vaginal Probiotic Plus Vaginal Clindamycin Cream for Bacterial Vaginosis a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03234517
- Acronym / sponsor ID
- zuh- 8
- Conditions
- Bacterial Vaginosis Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 31 Jul 2017 (actual)
- 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.
Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis
Detailed description
Vaginal Clindamycin Cream was used initially for treatment of Bacterial Vaginosis followed by Vaginal probiotic either in cnotinous or interrupted manner, then assessment of the results of treatment at different time intervals was done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic | Experimental | Drug: Vaginal Clindamycin Cream, Drug: Vaginal ProbioticVaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days |
| Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic | Active comparator | Drug: Vaginal Clindamycin Cream, Drug: Vaginal ProbioticVaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- more than 18 years
- has recurrent Bacterial Vaginosis
Key exclusion criteria (3 listed)
- pregnancy
- use of other antmicrobial
- not provide informed consent
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 |
|---|---|---|
| Vaginal Clindamycin CreamAlso: dalacin c creamVaginal Clindamycin Cream | Drug | Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic, Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic |
| Vaginal ProbioticAlso: dicoflor vaginal capsulesVaginal Probiotic | Drug | Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic, Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic |
Primary outcome
initial cure rate
Time frame: 2 months
number of women completely cured
1 secondary outcome
recurrence rate
Time frame: 4,6,8and12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Ibrahim A EL sharkwy principal investigator
FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vaginal Clindamycin Cream and Vaginal Probiotic in people with Bacterial Vaginosis Treatment, run by Zagazig University at 1 site in Egypt.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 2018. 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim A EL sharkwy (00966554818576, ibrahimsharkwy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
initial cure rate (time frame: 2 months). 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 7 Aug 2018.