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.

• Conditions: Bacterial vaginosis; Mixed candidiasis; Isolated candidiasis; Infection - Sexually transmitted infections; Infection - Other infectious diseases

• Registration Number: ACTRN12609000880246
• Lead Sponsor: Schering-Plough Industria Farmaceutica Ltda.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 100

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[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.]