ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Bacterial vaginosis

Mixed candidiasis

Isolated candidiasis

Condition category

Condition code

Infection

Sexually transmitted infections

Infection

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]

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]

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]

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]

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]

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]

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]

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?

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]

Brazil

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Schering-Plough Produtos Farmaceuticos Ltda.

Address [1]

Rua Olimpiadas, 205 - 14 e 15 andares - Continental Square Building
Vila Olimpia - Sao Paulo - SP
04551-000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

11/09/2009

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Tatiana Ferian da Fonseca

Address

Rua Borges Lagoa, 1080 - cj 101
Sao Paulo - SP
04038-002

Country

Brazil

Phone

55 11 5904 4454

Fax

tatiana@newcotrials.com

Contact person for scientific queries

Name

Tatiana Ferian da Fonseca

Address

Rua Borges Lagoa, 1080 - cj 101
Sao Paulo - SP
04038-002

Country

Brazil

Phone

55 11 5904 4454

Fax

tatiana@newcotrials.com

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically