Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies. (Frauen)
Primary Purpose
Sexual Active Women, Vaginal Discharge
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Clotrimazole + Metronidazole
Metronidazole
Clotrimazole
Sponsored by
About this trial
This is an interventional treatment trial for Sexual Active Women focused on measuring vaginal, discharge, women
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Colpistatin 5DT
Gynecological Flagyl
Gino-Canesten 3
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02713139
First Posted
March 15, 2016
Last Updated
March 15, 2016
Sponsor
Ache Laboratorios Farmaceuticos S.A.
1. Study Identification
Unique Protocol Identification Number
NCT02713139
Brief Title
Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.
Acronym
Frauen
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
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Due to budget limitations, the company decided to withdraw this study.
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ache Laboratorios Farmaceuticos S.A.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Active Women, Vaginal Discharge
Keywords
vaginal, discharge, women
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colpistatin 5DT
Arm Type
Experimental
Arm Title
Gynecological Flagyl
Arm Type
Active Comparator
Arm Title
Gino-Canesten 3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Clotrimazole + Metronidazole
Intervention Description
Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days.
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days.
Intervention Type
Drug
Intervention Name(s)
Clotrimazole
Intervention Description
Vaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days.
Primary Outcome Measure Information:
Title
Ceasing of the symptoms of vaginal discharge after 3(three) days of the end of the treatment
Description
Examination of the breasts and internal and external examination of the female genital organ.
Time Frame
From baseline to 3 days after the end of the treatment
Secondary Outcome Measure Information:
Title
Registry of Adverse Effects occurrence throughout the study
Description
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.
Time Frame
From baseline to 30 days after the end of the treatment
Title
Vaginal microflora reconstitution through microbiological evaluation of vaginal material
Description
Evaluation of the collected vaginal material with the microbiological tests(Whiff, Gram, Affirm VPIII) and PCR.
Time Frame
From baseline to 30 days after treatment's end
Title
Symptomatology recurrence and/or vaginal microflora alteration 30 days after the treatment's end
Description
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.
Time Frame
From baseline to 30 days after treatment's end
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo A. Junior, MD
Organizational Affiliation
Scentryphar Pesquisa Clínica Ltda
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.
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