VaginitisPhase 4NCT02444481
Open Study of the Efficacy of the Local Treatment With Polygynax of Bacterial and/or Mycotic Vaginitis
A Phase 4 study testing Polygynax combinaison of polymyxin, Neomycin and Nystatin in people with Vaginitis, run by Laboratoire Innotech International.
Trial summary
Open prospective multicenter phase IV study in patients presenting with symptoms of bacterial and/or mycotic (mushroom) vaginitis for 12 days as specified in the product information. Investigators/centers: 20 gynacologists are previewed to do the study in ambulatory treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vaginitis
- What is being tested?
- Polygynax combinaison of polymyxin, Neomycin and Nystatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Nov 2009
- Phase
- Phase 4
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Aged 18 years to 65 years
- Agreeing to provide written informed consent
- Presenting symptoms of vaginitis: unaccustomed leucorrhoea, pruritus, burning sensation on micturition, dyspareunia.
Who cannot join
- Patients in menstrual period,
- Virgins,
- Clinically detectable sexually transmissible infections (STI): genital lesions, evocative leucorrhoea, recent history of STI (< 3 months), known STI in partner,
- Sexually transmissible disease, including HIV,
- Pregnancy,
- Breastfeeding,
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- Known allergy or hypersensitivity to the treatment or to any of the ingredients of the treatment, and in particular, hypersensitivity to soya oil,
- Use of male or female condoms,
- Use of spermicide,
- Use of diaphragm,
- Clinical symptoms of non-sensitive bacterial vaginosis: runny and unpleasant smelling leucorrhoea suggesting Gardnerella vaginalis vaginitis,
- Concomitant topical or systemic anti-infective treatment,
- Topical or systemic anti-infective treatment in the 14 days prior to the study,
- Immunodepression or any other major disease rendering completion of the study or interpretation of the study results difficult,
- Immunosuppressant therapy,
- Chemotherapy,
- Participation in another clinical trial in the month prior to the study,
About this study
Official title: Open Multicenter Clinical Study of the Efficacy of the Local Treatment With Polygynax of Mycotic and/or Bacterial Vaginitis
Open prospective multicenter phase IV study in patients presenting with symptoms of bacterial and/or mycotic (mushroom) vaginitis for 12 days as specified in the product information.
Investigators/centers: 20 gynacologists are previewed to do the study in ambulatory treatment.
Read more
Objectifs of the study:
Principal objectif:
Evaluation of the efficacy of the treatment on the clinical symptoms of bacterial and/or mycotic vaginitis
Secondary objectif:
Evaluation of the efficacy of the treatment on eradication of the diagnosed germs Evaluation of the correspondence of the efficacy on the symptoms and on the eradication of the germs.
Numbers of patients previewed: 100 patients for evaluation of the efficacy
Criteria of evaluation
Principal criteria:
Clinical efficacy as judged by the investigator Secondary criteria:evaluation of clinical symptoms judged by the patient reduction or emlimination of bacteria and other germs the relationship between clinical and bacterial results
Evaluation of tolerance
Used Study Drug:
Polygynax, vaginal capsule consisting of Polymyxin 35000 UI, Neomycin 35000UI and Nystatin 100000UI Application: vaginal application once daily in the evening for 12 days
Study design:
Visit 1:
All patients presenting with the clinical symptoms, presenting all inclusion criteria and none of the exclusion criteria are included in the study at visit 1 and receive Polygynax treatment (one vaginal capsule once daily in the evening).
A vaginal smear is obtained. Visit 2 (optional) If the results of the bacteriological examination confirms an infection with germs sensible to the treatment with Polygynax the treatment is continued. If other germs not sensible to Polygynax are present, the patients is contacted to stop the treatment, to come back to a second visit to her gynacologist who will change the treatment. The other patients continue the treatment.
Visit 3:
After the treatment the patients come back to the last visit. A clinical evaluation and a vaginal smear for control is obtained.
- Conditions
- Vaginitis
- Being tested
- Polygynax combinaison of polymyxin, Neomycin and Nystatin
- Keywords
- Mycotic Vaginitis
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygynax combinaison of polymyxin, Neomycin and NystatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Polygynax, antibiotic, vaginal treatment | Experimental | Polygynax combinaison of nystatine, polymyxin, neomycin, Local treatment of vaginal infection during 12 days. One vaginal capsule every evening. Receives: Drug: Polygynax combinaison of polymyxin, Neomycin and Nystatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy on clinical symptoms as judged by the investigator
Clinical efficacy is judged upon symptoms
Measured: 14 days
Secondary outcomes (1)
Bacteriological efficacy on reduction of the presence of bacteria and /or fungus
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startApr 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire Innotech International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Marc Bohbot, Principal investigator, Institut Alfred Fournier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444481
- Sponsor's protocol ID
- PGX401-08
- Status last verified
- May 2015
- First submitted
- 14 May 2013
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Multicenter Clinical Study of the Efficacy of the Local Treatment With Polygynax of Mycotic and/or Bacterial Vaginitis
- ClinicalTrials.gov ID
- NCT02444481
- Acronym / sponsor ID
- PGX401-08
- Conditions
- Vaginitis
- Keywords
- Mycotic Vaginitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Laboratoire Innotech InternationalIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 14 May 2015 (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.
Open prospective multicenter phase IV study in patients presenting with symptoms of bacterial and/or mycotic (mushroom) vaginitis for 12 days as specified in the product information.
Investigators/centers: 20 gynacologists are previewed to do the study in ambulatory treatment.
Objectifs of the study:
Principal objectif:
Evaluation of the efficacy of the treatment on the clinical symptoms of bacterial and/or mycotic vaginitis
Secondary objectif:
Evaluation of the efficacy of the treatment on eradication of the diagnosed germs Evaluation of the correspondence of the efficacy on the symptoms and on the eradication of the germs.
Numbers of patients previewed: 100 patients for evaluation of the efficacy
Criteria of evaluation
Principal criteria:
Clinical efficacy as judged by the investigator Secondary criteria:evaluation of clinical symptoms judged by the patient reduction or emlimination of bacteria and other germs the relationship between clinical and bacterial results
Evaluation of tolerance
Used Study Drug:
Polygynax, vaginal capsule consisting of Polymyxin 35000 UI, Neomycin 35000UI and Nystatin 100000UI Application: vaginal application once daily in the evening for 12 days
Study design:
Visit 1:
All patients presenting with the clinical symptoms, presenting all inclusion criteria and none of the exclusion criteria are included in the study at visit 1 and receive Polygynax treatment (one vaginal capsule once daily in the evening).
A vaginal smear is obtained. Visit 2 (optional) If the results of the bacteriological examination confirms an infection with germs sensible to the treatment with Polygynax the treatment is continued. If other germs not sensible to Polygynax are present, the patients is contacted to stop the treatment, to come back to a second visit to her gynacologist who will change the treatment. The other patients continue the treatment.
Visit 3:
After the treatment the patients come back to the last visit. A clinical evaluation and a vaginal smear for control is obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polygynax, antibiotic, vaginal treatment | Experimental | Drug: Polygynax combinaison of polymyxin, Neomycin and NystatinPolygynax combinaison of nystatine, polymyxin, neomycin, Local treatment of vaginal infection during 12 days. One vaginal capsule every evening. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Aged 18 years to 65 years
- Agreeing to provide written informed consent
- Presenting symptoms of vaginitis: unaccustomed leucorrhoea, pruritus, burning sensation on micturition, dyspareunia.
Key exclusion criteria (17 listed)
- Patients in menstrual period,
- Virgins,
- Clinically detectable sexually transmissible infections (STI): genital lesions, evocative leucorrhoea, recent history of STI (< 3 months), known STI in partner,
- Sexually transmissible disease, including HIV,
- Pregnancy,
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 |
|---|---|---|
| Polygynax combinaison of polymyxin, Neomycin and Nystatin | Drug | Polygynax, antibiotic, vaginal treatment |
Primary outcome
Clinical efficacy on clinical symptoms as judged by the investigator
Time frame: 14 days
Clinical efficacy is judged upon symptoms
1 secondary outcome
Bacteriological efficacy on reduction of the presence of bacteria and /or fungus
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
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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.
Jean Marc Bohbot principal investigator
Institut Alfred Fournier
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polygynax combinaison of polymyxin, Neomycin and Nystatin in people with Vaginitis, run by Laboratoire Innotech International.
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 17 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: finished, as of the sponsor's last update on 14 May 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical efficacy on clinical symptoms as judged by the investigator (time frame: 14 days). 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 14 May 2015.