Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.

NCT ID: NCT02713139

Last Updated: 2016-03-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30

Brief Summary

The purpose of this study is to determine the efficacy and safety of the association clotrimazole 200mg and metronidazole 0,75%(Clopistatin 5DT®) and whether it is superior when compared with metronidazole 100mg/g (gynecologic Flagyl®) and clotrimazole 20mg/g (Gino-Canesten® 3) in the syndromic treatment of vaginal discharge from different etiologies.

Conditions

Sexual Active Women; Vaginal Discharge

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Colpistatin 5DT

Group Type: EXPERIMENTAL

Clotrimazole + Metronidazole

Intervention Type: DRUG

Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days.

Gynecological Flagyl

Group Type: ACTIVE_COMPARATOR

Metronidazole

Intervention Type: DRUG

Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days.

Gino-Canesten 3

Group Type: ACTIVE_COMPARATOR

Clotrimazole

Intervention Type: DRUG

Vaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days.

Interventions

Clotrimazole + Metronidazole

Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days.

Intervention Type: DRUG

Metronidazole

Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days.

Intervention Type: DRUG

Clotrimazole

Vaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects that have already started sexual activity;
• Subjects with complaints of vaginal discharge and had not received treatment in the 30 days before the enrollment visit;
• Subjects in the premenopausal period must be under usage of acceptable contraceptive methods(oral contraceptive, injectable contraceptives, IUD, hormonal implant, hormone transdermal adhesive, tubal ligation) or are surgically sterile (bilateral oophorectomy or hysterectomy); or accept to utilize a barrier contraceptive provided by the sponsor during the period of the study;
• Subjects with the capacity to comprehend and understand her participation in this clinical trial, manifested through informed consent form, even if with the help of another person (Legal representative).

Exclusion Criteria

• Subjects with chronic diseases (diabetes mellitus, neoplasia, renal failure, tuberculosis) or any clinical and/or laboratory find (anamnesis, physical exam and/or laboratory tests) that is interpreted, in the investigator's opinion, as a risk to the subject's participation in the clinical trial;
• Menopausal women;
• Known hyper-sensibility to any of the products' components;
• Pregnant or lactating women;
• Subjects with active genital ulcer and/or with Genital herpes diagnosis;
• Diagnosis or suspicion of Inflammatory pelvic disease;
• Diagnosis of Vulvar condyloma acuminata;
• Subjects under the usage of systemic corticosteroids for a period superior than 2 (two) months or under the usage of chemotherapeutics;
• Transplanted subjects;
• Subjects with history of active autoimmune diseases or with immune suppression;
• Subjects under the usage of medication or therapy described on the protocol item "Prohibited Treatments";
• Subjects that have participated on a clinical trial in the last 12 months (Conselho Nacional de Saúde - Resolução 251, de 7 de agosto de 1997, item III, sub-item J), unless the subject can have a direct benefit, in the investigator opinion;
• Subject that have a kinship or bond with any employees of Sponsor or Research center;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo A. Junior, MD

Role: PRINCIPAL_INVESTIGATOR

Scentryphar Pesquisa Clínica Ltda

Other Identifiers

ACH-CLP-03(05/12)

Identifier Type: -

Identifier Source: org_study_id