Prospective Clinical Study, Using a Medical Device (RepHegyn) as an Adjuvant in the Treatment of Fungal (Candidiasis) and Bacterial Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bacterial Infections, Treatment of Fungal Infections, Candidiasis. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- efficacy endpoint: VAS score for symptoms [Time frame: "From enrollment to the end of treatment at 12 days (evaluation after menstrual cycle)]
Secondary outcome measures (3)
- 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)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- ASST Rhodense, Dipartimento di ginecologia e ostetricia, Viale Forlanini 95 — Garbagnate Milanese
Identifiers
NCT: NCT07367295 · MD 07b/2025/Rephe