Bacterial InfectionsNCT07367295
Prospective Clinical Study, Using a Medical Device (RepHegyn) as an Adjuvant in the Treatment of Fungal (Candidiasis) and Bacterial Infections
An observational study of Bacterial Infections and Treatment of Fungal Infections, Candidiasis, run by Innate srl at 1 site in Italy.
Trial summary
The medical device It is indicated to promote the re-epithelialization processes of the vaginal mucosa, in the prevention of vaginal conditions of bacterial and fungal origin, and as an adjuvant in their treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Bacterial Infections, Treatment of Fungal Infections, Candidiasis
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- May 2026to Aug 2026
- How long will I take part?
- 12 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female: form 18 - 75 years old
Who may be able to join
- Age between 18 and 75 years
- Signed written informed consent.
- At least two subjective symptoms and two objective signs (at least moderate) of vaginal inflammation due to infection. Vaginal inflammation will be assessed based on six subjective symptoms (burning, pain, itching, irritation, dyspareunia, and dysuria) and four objective signs (swelling, vaginal discharge typical of the infection, pH, and presence of abrasion/erosion).
- Confirmed recurrent bacterial vaginosis and candidiasis.
- Patient able to maintain a patient diary during the study.
- Patient is able to read and understand the language and content of the study materials, understands the requirements for follow-up visits, is willing to provide information at scheduled assessments, and is willing and able to comply with study requirements.
Who cannot join
- Patients who do not sign the informed consent form
- Other gynecological diseases, immunosuppressive diseases (e.g., HIV infection), or who are immunocompromised for reasons such as corticosteroid therapy, chemotherapy, anti-angiogenic agents, or immunosuppressants, patients with diabetes
- Patients receiving antibiotics, anti-inflammatory agents, analgesics, antineoplastic drugs, or immunosuppressants within 4 weeks prior to study inclusion
- History of connective tissue diseases, e.g., systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, or mixed connective tissue disease
- Known allergy to any component of the device
- Subjects unable to understand the informed consent form or who have a high likelihood of non-compliance with study procedures and/or non-completion of the study according to the investigator's judgment
Show all 9Show fewer
- Pregnancy and breastfeeding
- Time between the last day of the last menstrual period and the baseline visit >16 days or ≤5 days (for non-menopausal subjects).
- Participation in other clinical studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
ASST Rhodense, Dipartimento di ginecologia e ostetricia, Viale Forlanini 95
Garbagnate Milanese, Michigan, 20024
Ambrogio Frigerio, +39 02 994303352, afrigerio@asst-rhodense.it
About this study
Official title: Prospective Clinical Study, Using a Medical Device as an Adjuvant in the Treatment of Fungal (Candidiasis) and Bacterial Infections: Evaluation of the Safety and Efficacy of Rephegyn Vaginal Ovules
The medical device It is indicated to promote the re-epithelialization processes of the vaginal mucosa, in the prevention of vaginal conditions of bacterial and fungal origin, and as an adjuvant in their treatment.
The primary efficacy endpoint is based on the VAS symptom score (abnormal vaginal discharge, lower abdominal pain, dysuria, burning micturition, dyspareunia, vulvar irritation, and itching on a 10-point scale), specifically the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of recurrent bacterial and fungal infections (total symptom score <2) at the end of treatment.
- Keywords
- candidiasis, bacterial infection, RepHegyn, pH restoring, barrier action
- Medical subject headings
- Bacterial Infections, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Age between 18 and 75 years, female | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy endpoint: VAS score for symptoms
The primary efficacy endpoint is based on the VAS score for symptoms (abnormal vaginal discharge, lower abdominal pain, dysuria, burning micturition, dyspareunia, vulvar irritation, and itching on a 10-point scale), specifically the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of recurrent bacterial and fungal infections (total symptom score <2) at the end of treatment reported below.
Measured: "From enrollment to the end of treatment at 12 days (evaluation after menstrual cycle)
Secondary outcomes (3)
efficacy: evaluation of pH
evaluation of pH with instrument for pH
Measured: "From enrollment to the end of treatment at 12 days (after menstrual cycle)
efficacy: VAS evaluation
The change from the semi-quantitative baseline score, expressed both for individual signs and symptoms and for their sum (total symptom VAS)
Measured: From enrollment to the end of treatment at 12 days (after menstrual cycle)
safety endpoint
The safety and tolerability of the treatments will be evaluated by investigating local and expected adverse events, as a consequence of the application of the product and any other adverse events occurring during the study.
Measured: From enrollment to the end of treatment at 12 days (after menstrual cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
- Target duration
- 12 Days
Sponsor and investigators
- Lead sponsor
- Innate srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367295
- Sponsor's protocol ID
- MD 07b/2025/Rephe
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study, Using a Medical Device as an Adjuvant in the Treatment of Fungal (Candidiasis) and Bacterial Infections: Evaluation of the Safety and Efficacy of Rephegyn Vaginal Ovules
- ClinicalTrials.gov ID
- NCT07367295
- Acronym / sponsor ID
- MD 07b/2025/Rephe
- Keywords
- candidiasis, bacterial infection, RepHegyn, pH restoring, barrier action
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Innate srlIndustry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- 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 medical device It is indicated to promote the re-epithelialization processes of the vaginal mucosa, in the prevention of vaginal conditions of bacterial and fungal origin, and as an adjuvant in their treatment.
The primary efficacy endpoint is based on the VAS symptom score (abnormal vaginal discharge, lower abdominal pain, dysuria, burning micturition, dyspareunia, vulvar irritation, and itching on a 10-point scale), specifically the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of recurrent bacterial and fungal infections (total symptom score <2) at the end of treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age between 18 and 75 years, female | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female: form 18 - 75 years old
Key inclusion criteria (6 listed)
- Age between 18 and 75 years
- Signed written informed consent.
- At least two subjective symptoms and two objective signs (at least moderate) of vaginal inflammation due to infection. Vaginal inflammation will be assessed based on six subjective symptoms (burning, pain, itching, irritation, dyspareunia, and dysuria) and four objective signs (swelling, vaginal discharge typical of the infection, pH, and presence of abrasion/erosion).
- Confirmed recurrent bacterial vaginosis and candidiasis.
- Patient able to maintain a patient diary during the study.
Key exclusion criteria (9 listed)
- Patients who do not sign the informed consent form
- Other gynecological diseases, immunosuppressive diseases (e.g., HIV infection), or who are immunocompromised for reasons such as corticosteroid therapy, chemotherapy, anti-angiogenic agents, or immunosuppressants, patients with diabetes
- Patients receiving antibiotics, anti-inflammatory agents, analgesics, antineoplastic drugs, or immunosuppressants within 4 weeks prior to study inclusion
- History of connective tissue diseases, e.g., systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, or mixed connective tissue disease
- Known allergy to any component of the device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
efficacy endpoint: VAS score for symptoms
Time frame: "From enrollment to the end of treatment at 12 days (evaluation after menstrual cycle)
The primary efficacy endpoint is based on the VAS score for symptoms (abnormal vaginal discharge, lower abdominal pain, dysuria, burning micturition, dyspareunia, vulvar irritation, and itching on a 10-point scale), specifically the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of recurrent bacterial and fungal infections (total symptom score <2) at the end of treatment reported below.
3 secondary outcomes
efficacy: evaluation of pH
Time frame: "From enrollment to the end of treatment at 12 days (after menstrual cycle)
efficacy: VAS evaluation
Time frame: From enrollment to the end of treatment at 12 days (after menstrual cycle)
safety endpoint
Time frame: From enrollment to the end of treatment at 12 days (after menstrual cycle)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections and Treatment of Fungal Infections, Candidiasis, run by Innate srl at 1 site in Italy.
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 6 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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ambrogio Frigerio, Medical doctor (gynecology) (+39 02 994303352, afrigerio@asst-rhodense.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy endpoint: VAS score for symptoms (time frame: "From enrollment to the end of treatment at 12 days (evaluation after menstrual cycle)). 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 Apr 2026.