VaginitisPhase 3PRISMNCT02515656
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
A Phase 3 study testing POLYGYNAX® and GYNODAKTARIN® in people with Vaginitis, run by Laboratoire Innotech International at 4 sites in 4 countries.
Trial summary
POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Vaginitis
- What is being tested?
- POLYGYNAX® and GYNODAKTARIN®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 661 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2015to Aug 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient with an abnormal vaginal discharge associated with one (or more) functional vaginal complaints: vaginal burning and/or vaginal pain and/or vaginal irritation clinically evoking an infectious vaginitis:
- bacterial vaginitis
- non-specific vaginitis (atypical symptoms)
- mixed vaginitis (i.e. suprainfected fungal vaginitis) and able to receive an empirical local treatment
Who cannot join
- Recurrent patient; i.e. a patient who has had at least 4 episodes of infectious vaginitis in the 12 months prior to inclusion
- Vaginal infection justifying systemic therapy
- History of atrophic vaginitis or suspected atrophic vaginitis at inclusion
- Patient presenting with signs of genital herpes or signs of non-infectious vulvar pathology (vulvodynia, psoriasis, eczema, lichen sclerosus, lichen planus, contact dermatitis, candida intertrigo, vulval intraepithelial neoplasia (VIN))
- Patient with current Sexually Transmitted Infection (STI) and/or patients with clinical suspicion of STI
- Disease or concomitant treatment that could cause decreased immunity (i.e. diabetes mellitus, corticosteroids treatments)
Show all 9Show fewer
- Systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to inclusion
- Patient menstruating or patient with menometrorrhagia due to hormonal imbalance at the time of inclusion
- Pregnant or lactating women or delivery within last 1 month
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis International, Multicentre, Randomised, Double-blind, Parallel Group Study, Comparative Versus Miconazole
POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.
Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone.
The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.
- Conditions
- Vaginitis
- Being tested
- POLYGYNAX®, GYNODAKTARIN®, Placebo
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POLYGYNAX®Drug
GYNODAKTARIN®Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| POLYGYNAX® | Experimental | Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules Receives: Drug: POLYGYNAX® |
| miconazole + placebo | Active comparator | Name : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules Receives: Drug: GYNODAKTARIN®; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit
- Success is defined by resolution (return to patient's usual gynaecological conditions, i.e. before the episode which warranted inclusion in the study) OR substantial improvement of clinical signs of infectious vaginitis (i.e. abnormal vaginal discharge), and/or vaginal symptoms (vaginal burning and/or vaginal pain, and/or vaginal irritation).
- Failure is defined by persistence or worsening of symptoms and clinical signs or requirement of an alternative or specific treatment.
Not considered as "Treatment Failure":
- The need to initiate a specific treatment because of a Sexually Transmitted Infection (STI) (trichomoniasis; gonococcal and chlamydial infections) detected from the vaginal sample at Visit 1 / D1.
- Patients presenting with only vulvar complaints not considered as related to infectious vaginitis.
Measured: 15 days after first treatment administration
Secondary outcomes (5)
Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary
This outcome was evaluated using a Visual Analogue Scale (VAS) completed by the patient.
The scale measured the level of each vaginal symptom experienced during the day (vaginal discharge, vaginal burning, vaginal pain and vaginal irritation).
Scale ranges = 0 to 100 0=none symptom 100=maximum intensity of symptom Time points used in the calculation= D1 to D14
Measured: during 14 days after first treatment intake
Number of Patients With Change in Vaginal Discharge Assessed by the Investigator
The vaginal discharge is assessed by the investigator by using a score:
0=absent
- mild: insufficient for speculum collection
- moderate: sufficient for speculum collection
- abundant: visible at the introitus even before speculum introduction.
Measured: 15 days after first treatment administration
Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit
Success and Failure (same definition as the primary outcome measure)
Measured: 22 days after first treatment administration
Investigator's Global Satisfaction
The investigator filled the satisfaction questionnaire during the end of treatment visit.
Six ratings are available: Very Bad, Bad, Somewhat Bad, Somewhat Good, Good and Very Good.
Measured: 15 days after first administration
Patient's Global Satisfaction
The patient filled the satisfaction questionnaire on her patient's diary at home the eve of the End of Treatment Visit.
Six ratings are available: Very Bad, Bad, Somewhat Bad, Somewhat Good, Good and Very Good.
Measured: 15 days after first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire Innotech International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Clinical Trials Association, Venn Life Sciences
- Responsible party
- Sponsor
- Investigators
- Jean-Marc BOHBOT, Dr, Principal investigator, Institut Alfred Fournier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515656
- Sponsor's protocol ID
- PGX 401-11
- Other IDs
- 2014-001759-22, 2014
- Acronym
- PRISM
- Status last verified
- Aug 2018
- First submitted
- 29 Jul 2015
- Last updated
- 22 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis International, Multicentre, Randomised, Double-blind, Parallel Group Study, Comparative Versus Miconazole
- ClinicalTrials.gov ID
- NCT02515656
- Acronym / sponsor ID
- PRISM / PGX 401-11
- Conditions
- Vaginitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- Laboratoire Innotech InternationalIndustry (pharma, biotech, devices)
- Collaborators
- International Clinical Trials Association, Venn Life Sciences
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Posted 22 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.
Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone.
The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POLYGYNAX® | Experimental | Drug: POLYGYNAX®Name : POLYGYNAX® Active components : nystatin 100 000 IU + neomycin sulphate 35 000 IU + polymyxin B sulphate 35 000 IU Dosage : 1 capsule intravaginally per day (administered at bedtime lying down) 12 vaginal soft capsules |
| miconazole + placebo | Active comparator | Drug: GYNODAKTARIN®, Drug: PlaceboName : GYNODAKTARIN® Active components : miconazole nitrate 400 mg Dosage : 1 capsule intravaginally per day (administered at bedtime, lying down) 3 vaginal soft capsules followed by 9 placebo vaginal soft capsules |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient with an abnormal vaginal discharge associated with one (or more) functional vaginal complaints: vaginal burning and/or vaginal pain and/or vaginal irritation clinically evoking an infectious vaginitis:
Key exclusion criteria (9 listed)
- Recurrent patient; i.e. a patient who has had at least 4 episodes of infectious vaginitis in the 12 months prior to inclusion
- Vaginal infection justifying systemic therapy
- History of atrophic vaginitis or suspected atrophic vaginitis at inclusion
- Patient presenting with signs of genital herpes or signs of non-infectious vulvar pathology (vulvodynia, psoriasis, eczema, lichen sclerosus, lichen planus, contact dermatitis, candida intertrigo, vulval intraepithelial neoplasia (VIN))
- Patient with current Sexually Transmitted Infection (STI) and/or patients with clinical suspicion of STI
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® | Drug | POLYGYNAX® |
| GYNODAKTARIN® | Drug | miconazole + placebo |
| Placebo | Drug | miconazole + placebo |
Primary outcome
Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit
Time frame: 15 days after first treatment administration
* Success is defined by resolution (return to patient's usual gynaecological conditions, i.e. before the episode which warranted inclusion in the study) OR substantial improvement of clinical signs of infectious vaginitis (i.e. abnormal vaginal discharge), and/or vaginal symptoms (vaginal burning and/or vaginal pain, and/or vaginal irritation). * Failure is defined by persistence or worsening of symptoms and clinical signs or requirement of an alternative or specific treatment. Not considered as "Treatment Failure": * The need to initiate a specific treatment because of a Sexually Transmitted Infection (STI) (trichomoniasis; gonococcal and chlamydial infections) detected from the vaginal sample at Visit 1 / D1. * Patients presenting with only vulvar complaints not considered as related to infectious vaginitis.
5 secondary outcomes
Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary
Time frame: during 14 days after first treatment intake
Number of Patients With Change in Vaginal Discharge Assessed by the Investigator
Time frame: 15 days after first treatment administration
Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit
Time frame: 22 days after first treatment administration
Investigator's Global Satisfaction
Time frame: 15 days after first administration
Patient's Global Satisfaction
Time frame: 15 days after first administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Vaginitis
Enrolling by invitationObservational study
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
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, Dr principal investigator
Institut Alfred Fournier
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing POLYGYNAX® and GYNODAKTARIN® in people with Vaginitis, run by Laboratoire Innotech International at 4 sites in 4 countries.
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 9 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 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia, France, Serbia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 22 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit (time frame: 15 days after first treatment administration). 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 22 Jan 2019.