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

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ClinicalTrials.gov Identifier: NCT02713139
Recruitment Status : Withdrawn (Due to budget limitations, the company decided to withdraw this study.)
First Posted : March 18, 2016
Last Update Posted : March 18, 2016
Sponsor:
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.

Tracking Information
First Submitted Date  ICMJE March 15, 2016
First Posted Date  ICMJE March 18, 2016
Last Update Posted Date March 18, 2016
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
Ceasing of the symptoms of vaginal discharge after 3(three) days of the end of the treatment [ Time Frame: From baseline to 3 days after the end of the treatment ]
Examination of the breasts and internal and external examination of the female genital organ.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2016)
  • Registry of Adverse Effects occurrence throughout the study [ Time Frame: From baseline to 30 days after the end of the treatment ]
    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 [ Time Frame: From baseline to 30 days after treatment's end ]
    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 [ Time Frame: From baseline to 30 days after 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sexual Active Women
  • Vaginal Discharge
Intervention  ICMJE
  • Drug: Clotrimazole + Metronidazole
    Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days.
  • Drug: Metronidazole
    Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days.
  • Drug: Clotrimazole
    Vaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days.
Study Arms  ICMJE
  • Experimental: Colpistatin 5DT
    Intervention: Drug: Clotrimazole + Metronidazole
  • Active Comparator: Gynecological Flagyl
    Intervention: Drug: Metronidazole
  • Active Comparator: Gino-Canesten 3
    Intervention: Drug: Clotrimazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 15, 2016)
0
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02713139
Other Study ID Numbers  ICMJE ACH-CLP-03(05/12)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ache Laboratorios Farmaceuticos S.A.
Study Sponsor  ICMJE Ache Laboratorios Farmaceuticos S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eduardo A. Junior, MD Scentryphar Pesquisa Clínica Ltda
PRS Account Ache Laboratorios Farmaceuticos S.A.
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP