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NCT Number: NCT07367295

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

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.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Candidiasis Infections Mycoses Treatment of Fungal Infections, Candidiasis

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

ASST Rhodense, Dipartimento di ginecologia e ostetricia, Viale Forlanini 95

Garbagnate Milanese, Michigan, 20024, Italy

Location contact

Ambrogio Frigerio

CONTACT

[email protected]

+39 02 994303352

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. efficacy: evaluation of pH

    Time frame: "From enrollment to the end of treatment at 12 days (after menstrual cycle)

    evaluation of pH with instrument for pH

  2. efficacy: VAS evaluation

    Time frame: From enrollment to the end of treatment at 12 days (after menstrual cycle)

    The change from the semi-quantitative baseline score, expressed both for individual signs and symptoms and for their sum (total symptom VAS)

  3. safety endpoint

    Time frame: From enrollment to the end of treatment at 12 days (after menstrual cycle)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ambrogio Frigerio, Medical doctor (gynecology)

CONTACT

[email protected]

+39 02 994303352

Andrea Borgatta

CONTACT

[email protected]

+393472644870

Sponsors and collaborators

Lead sponsor

Innate srl

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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