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

NCT02713139 | Withdrawn Phase 3 DMC

• 1 other identifier: ACH-CLP-03(05/12)
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

vaginal; discharge; women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Registry of Adverse Effects occurrence throughout the study

  From baseline to 30 days after the end of the treatment

• Vaginal microflora reconstitution through microbiological evaluation of vaginal material

  From baseline to 30 days after treatment's end

• Symptomatology recurrence and/or vaginal microflora alteration 30 days after the treatment's end

  From baseline to 30 days after treatment's end

Study Arms (3)

Colpistatin 5DT

EXPERIMENTAL

Drug: Clotrimazole + Metronidazole

Gynecological Flagyl

ACTIVE COMPARATOR

Drug: Metronidazole

Gino-Canesten 3

ACTIVE COMPARATOR

Drug: Clotrimazole

Interventions

Clotrimazole + Metronidazole DRUG

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

Colpistatin 5DT

Metronidazole DRUG

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

Gynecological Flagyl

Clotrimazole DRUG

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

Gino-Canesten 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

MeSH Terms

Conditions

Vaginal Discharge

Interventions

Clotrimazole; Metronidazole

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals

Study Officials

• Eduardo A. Junior, MD

  Scentryphar Pesquisa Clínica Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Last Updated: March 18, 2016

Record last verified: 2016-03