Sexual Active WomenPhase 3FrauenNCT02713139
Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.
A Phase 3 study testing Clotrimazole + Metronidazole, Metronidazole and Clotrimazole in people with Sexual Active Women and Vaginal Discharge, run by Ache Laboratorios Farmaceuticos S.A..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Sexual Active Women, Vaginal Discharge
- What is being tested?
- Clotrimazole + Metronidazole, Metronidazole and Clotrimazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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;
About this study
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.
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
- Being tested
- Clotrimazole + Metronidazole, Metronidazole, Clotrimazole
- Keywords
- vaginal, discharge, women
- Medical subject headings
- Vaginal Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clotrimazole + MetronidazoleDrug
Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days.
MetronidazoleDrug
Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days.
ClotrimazoleDrug
Vaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days.
| Study group | Role | What they receive |
|---|---|---|
| Colpistatin 5DT | Experimental | Not described Receives: Drug: Clotrimazole + Metronidazole |
| Gynecological Flagyl | Active comparator | Not described Receives: Drug: Metronidazole |
| Gino-Canesten 3 | Active comparator | Not described Receives: Drug: Clotrimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 3 days after the end of the treatment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From baseline to 30 days after treatment's end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startSep 2013
- Primary completionMar 2014 (estimated)
Why it stopped: Due to budget limitations, the company decided to withdraw this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Active WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eduardo A. Junior, MD, Principal investigator, Scentryphar Pesquisa Clínica Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713139
- Sponsor's protocol ID
- ACH-CLP-03(05/12)
- Acronym
- Frauen
- Status last verified
- Mar 2016
- First submitted
- 15 Mar 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02713139
- Acronym / sponsor ID
- Frauen / ACH-CLP-03(05/12)
- Conditions
- Sexual Active Women, Vaginal Discharge
- Keywords
- vaginal, discharge, women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to budget limitations, the company decided to withdraw this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (estimated)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colpistatin 5DT | Experimental | Drug: Clotrimazole + Metronidazole |
| Gynecological Flagyl | Active comparator | Drug: Metronidazole |
| Gino-Canesten 3 | Active comparator | Drug: Clotrimazole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clotrimazole + MetronidazoleVaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days. | Drug | Colpistatin 5DT |
| MetronidazoleVaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days. | Drug | Gynecological Flagyl |
| ClotrimazoleVaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days. | Drug | Gino-Canesten 3 |
Primary outcome
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.
3 secondary outcomes
Registry of Adverse Effects occurrence throughout the study
Time frame: From baseline to 30 days after the end of the treatment
Vaginal microflora reconstitution through microbiological evaluation of vaginal material
Time frame: From baseline to 30 days after treatment's end
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo A. Junior, MD principal investigator
Scentryphar Pesquisa Clínica Ltda
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clotrimazole + Metronidazole, Metronidazole and Clotrimazole in people with Sexual Active Women and Vaginal Discharge, run by Ache Laboratorios Farmaceuticos S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2016.