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Trial registered on ANZCTR


Registration number
ACTRN12609000880246
Ethics application status
Not yet submitted
Date submitted
2/10/2009
Date registered
9/10/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 3b, comparative and randomized study to evaluate the efficacy and safety of ketoconazole associated to clindamycin in vaginal ovules versus tetracyclin associated to amphotericin B in vaginal cream in bacterial vaginosis and mixed or isolated vaginal candidiasis treatment.
Scientific title
Phase 3b, comparative and randomized study to evaluate the efficacy and safety of ketoconazole associated to clindamycin in vaginal ovules versus tetracyclin associated to amphotericin B in vaginal cream in bacterial vaginosis and mixed or isolated vaginal candidiasis treatment.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial vaginosis 243832 0
Mixed candidiasis 243833 0
Isolated candidiasis 243834 0
Condition category
Condition code
Infection 240009 240009 0 0
Sexually transmitted infections
Infection 252159 252159 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vaginal ovules with a combination of ketoconazole 800 mg and clindamicyn 100 mg. Posology: 1 disposable applicator with 1 ovule daily, during 3 days in intravaginal route.
Intervention code [1] 241272 0
Treatment: Drugs
Comparator / control treatment
Vaginal cream with a combination of tetraciclin chloridrate 100 mg associated to amphotericin B 50 mg. Posology: 1 disposable applicator daily (4g of cream), during 7 - 10 days, intravaginal route.
Control group
Active

Outcomes
Primary outcome [1] 240909 0
Assessment of clinical and microbiologic cure with the use of vaginal cream tetracycline and amphotericin B for treatment of bacterial vaginosis and/or isolated or mixed vaginal candidiasis. Bacterial vaginosis will be evaluated by Amsel and Nugent criteria.
Timepoint [1] 240909 0
Evaluation will be measured in visit 1 (selection and iniciation of the treatmen), visit 2 (week 2 - after treatment), visit 3 (week 4 - follow-up). The patients will be evaluated through the clinical cure evidence.
Secondary outcome [1] 257616 0
Evaluation of both treatments safety and tolerability by assessment of patient adverse events reports (serious and non serious events) that occurred during the study period. Vaginal drugs rarely presents alergic reactions or other adverse event, however every single adverse event presented during the study (28 days - Visit 1, treatment period and follow up period) will be followed. The adverse events will be assessed by patient reports during each study visit and/or patient contact at any time. Non serious adverse events will be recorded at the Case Report Form (CRF) and serious adverse events will be recorded at a special serious adverse event report form (e.g. Council for International Organizations of Medical Sciences (CIOMS)
Timepoint [1] 257616 0
Adverse event will be evaluated during all study (28 days): after visit 1 (day 1), visit 2 (day 14) and visit 3 (day 28).
Secondary outcome [2] 257843 0
Identify and assess adherence to treatment and preferences.
The adherence will be assessed asking to patients keep all supplies and bring back to visit when site staff will verify if the medication was used correctly. The patients will receive a box with 3 ovules + applicator (for 3 days of treatment) or a box with a tube + applicator (for 7 days of treatment) and has to bring it empty.
To assess the preference, the patient will be asked how she felt using that medication (unconfortable, ease to applicate, etc.). The patients will use only one medication in the study and the preference will be measured comparing the answers between them.
Timepoint [2] 257843 0
The adherence and preference of treatment will be asked in visit 2.

Eligibility
Key inclusion criteria
- Patients between 18 and 45 years old;
- Diagnosis of vaginal candidiasis with laboratorial confirmation, and/or diagnosis of bacterial vaginosis according to Amsel and Nugent criteria;
- Absence of Trichomonas vaginallis or other protozoal.
- Absence of clinical evidence of infection with Neisseria gonorrhoeae, Chlamydia trachomatis or viral infection.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with known sensibility to formula compounds;
- Pregnant patients or in lactancy period;
- Any ginecologic condition that contra-indicate the use of vaginal ovules or creams;
- Use of any other local or sistemic anti-bacterial, anti-protozoary or anti-fungic agent in the two weeks before the study or during the same time;
- Pacients with other sexually transmissive diseases (except candida vaginitis);
- Patients with history of candidiasis (4 or more episodes per year);
- Use of intrauterine device, spermicides or diaphragm;
- Patients with metabolic or uncontrolled immune disorders;
- Patients with anormal uterine bleeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2139 0
Brazil
State/province [1] 2139 0

Funding & Sponsors
Funding source category [1] 243766 0
Commercial sector/Industry
Name [1] 243766 0
Schering-Plough Produtos Farmaceuticos Ltda.
Country [1] 243766 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Schering-Plough Industria Farmaceutica Ltda.
Address
Rua Olimpiadas, 205 - 14 e 15 andares - Continental Square Building
Vila Olimpia - Sao Paulo - SP
04551-000
Country
Brazil
Secondary sponsor category [1] 237124 0
None
Name [1] 237124 0
Address [1] 237124 0
Country [1] 237124 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 243896 0
Ethics committee address [1] 243896 0
Ethics committee country [1] 243896 0
Date submitted for ethics approval [1] 243896 0
11/09/2009
Approval date [1] 243896 0
Ethics approval number [1] 243896 0

Summary
Brief summary
Bacterial vaginosis is the most common cause of vaginitis and occurs in 50% of cases; candida vaginitis is the second most frequent corresponding 20 to 40% of cases; and with minor frequence the trichomoniasis occurs in 10 to 30% of cases.
Mixed vaginal infections are rather frequent: in a review 100 patients with vaginal infections, more than one pathogen was observed in 23% pacients with bacterial vaginosis and in 18% pacients with candida vaginitis.
When the normal flora is altered, with decrease of Döderlein lactobacillus and altered vaginal pH, candida species can proliferate and vulvovaginitis appears.
Vaginal discharge is the most commom cause of medical clinics in gynecology.
The correct diagnosis is difficult to make. Aproximately 1/3 pacientes do not have correct diagnosis even when a lab test is performed.
Tests could not be available and many associations of drugs are available in the market for the treatment of vulvovaginitis but most of them are not available in topic form. An option of concomitant or associated therapy is ketoconazole with clindamycin or tetracyclin and amphotericin B.
Oral ketoconazole is widely and traditionally used for treating vaginal candidiasis, but in our country the topic use is not yet available for this statement, but only for fungal skin infections. The intravaginal administration of ketoconazole became possible because of the development of bioadhesive vehicles.
Clindamycin is active against most anaerobic microorganisms. Vaginally adminstered clindamycin is effective for the treatment of bacterial vaginosis by Gardnerella vaginalis and the combination of tetracycline and amphotericin B is commercially available and is indicated for the treatment of vaginal infections caused by fungus and bacteria.
The purpose of this study is to evaluate the clinical and micobiologic cure, which will be analised by Amsel and Nuget criteria. Safety and tolerability will be evaluated during the study period. The adherence and preferences of the patientes will be identified and evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30283 0
Address 30283 0
Country 30283 0
Phone 30283 0
Fax 30283 0
Email 30283 0
Contact person for public queries
Name 13530 0
Tatiana Ferian da Fonseca
Address 13530 0
Rua Borges Lagoa, 1080 - cj 101
Sao Paulo - SP
04038-002
Country 13530 0
Brazil
Phone 13530 0
55 11 5904 4454
Fax 13530 0
Email 13530 0
[email protected]
Contact person for scientific queries
Name 4458 0
Tatiana Ferian da Fonseca
Address 4458 0
Rua Borges Lagoa, 1080 - cj 101
Sao Paulo - SP
04038-002
Country 4458 0
Brazil
Phone 4458 0
55 11 5904 4454
Fax 4458 0
Email 4458 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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