None listed
Conditions
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.
Interventions
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.
Sponsors
Schering-Plough Industria Farmaceutica Ltda.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Outcome results
None listed