Prospective Clinical Study, Using a Medical Device (RepHegyn) as an Adjuvant in the Treatment of Fungal (Candidiasis) and Bacterial Infections

Официальное название

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

Обзор

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.

Первичные конечные точки

• efficacy endpoint: VAS score for symptoms [Срок оценки: "From enrollment to the end of treatment at 12 days (evaluation after menstrual cycle)]

Вторичные конечные точки (3)

• efficacy: evaluation of pH [Срок оценки: "From enrollment to the end of treatment at 12 days (after menstrual cycle)]
• efficacy: VAS evaluation [Срок оценки: From enrollment to the end of treatment at 12 days (after menstrual cycle)]
• safety endpoint [Срок оценки: From enrollment to the end of treatment at 12 days (after menstrual cycle)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Италия · 1 центр

• ASST Rhodense, Dipartimento di ginecologia e ostetricia, Viale Forlanini 95 — Garbagnate Milanese

Идентификаторы

NCT: NCT07367295 · MD 07b/2025/Rephe

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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