Clinical trial NCT02713139: Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.
Official title: Phase III, Multicenter, Randomized, Parallel, Open Label, Controlled and Comparative Study to Evaluate the Efficacy and Safety of the Association of Clotrimazole 200mg and Metronidazole 0,75% (Colpistatin 5DT®) Compared to Gynecological Flagyl®(Metronidazole 100mg/g) and the Vaginal Cream Gino-Canesten® 3 (Clotrimazole 20mg/g) in the Syndromic Treatment of the Vaginal Discharge From Different Etiologies.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Sexual Active Women
Vaginal Discharge
Keywords: vaginal
discharge
women
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2016-03-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Ceasing of the symptoms of vaginal discharge after 3(three) days of the end of the treatment
timeFrame: From baseline to 3 days after the end of the treatment
Secondary outcomes:
measure: Registry of Adverse Effects occurrence throughout the study
timeFrame: From baseline to 30 days after the end of the treatment
measure: Vaginal microflora reconstitution through microbiological evaluation of vaginal material
timeFrame: From baseline to 30 days after treatment's end
measure: Symptomatology recurrence and/or vaginal microflora alteration 30 days after the treatment's end
timeFrame: From baseline to 30 days after treatment's end
Other outcomes:
Locations:
Study officials:
affiliation: Scentryphar Pesquisa Clínica Ltda
name: Eduardo A. Junior, MD
role: PRINCIPAL_INVESTIGATOR
References: