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

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Sexual Active Women; Vaginal Discharge
• Intervention / Treatment: Drug: Clotrimazole + Metronidazole; Drug: Metronidazole; Drug: Clotrimazole

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colpistatin 5DT	Drug: Clotrimazole + Metronidazole; Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days.
Active Comparator: Gynecological Flagyl	Drug: Metronidazole; Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days.
Active Comparator: Gino-Canesten 3	Drug: Clotrimazole; Vaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ceasing of the symptoms of vaginal discharge after 3(three) days of the end of the treatment	Examination of the breasts and internal and external examination of the female genital organ.	From baseline to 3 days after the end of the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Registry of Adverse Effects occurrence throughout the study	Evaluation of Clinical and Physical examination and the measure of vital signs; Evaluation of Adverse effects; Evaluation of Laboratory exams; And evaluation of urine beta-hcg test.	From baseline to 30 days after the end of the treatment
Vaginal microflora reconstitution through microbiological evaluation of vaginal material	Evaluation of the collected vaginal material with the microbiological tests(Whiff, Gram, Affirm VPIII) and PCR.	From baseline to 30 days after treatment's end
Symptomatology recurrence and/or vaginal microflora alteration 30 days after the treatment's end	Examination of the breasts and internal and external examination of the female genital organ. Evaluation of the collected vaginal material with the microbiological tests(Whiff, Gram, Affirm VPIII) and PCR.	From baseline to 30 days after treatment's end

Collaborators and Investigators

• Sponsor: Ache Laboratorios Farmaceuticos S.A.
• Investigators: Principal Investigator: Eduardo A. Junior, MD, Scentryphar Pesquisa Clinica Ltda

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): March 1, 2014
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Estimate): March 18, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: women; vaginal; discharge
• Additional Relevant MeSH Terms: Vaginal Diseases; Vaginal Discharge; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Metronidazole; Clotrimazole; Miconazole
• Other Study ID Numbers: ACH-CLP-03(05/12)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No