New vaginal ovule aims to soothe recurrent infections
NCT ID NCT07367295
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a medical device called Rephegyn vaginal ovules to help treat fungal (candidiasis) and bacterial infections. The device is designed to help heal the vaginal lining and reduce symptoms like discharge, pain, and itching. About 34 adults with recurrent infections will use the ovules, and researchers will check if symptoms improve by the end of treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
May 2026
An estimate. Start dates often move.
- Expected to finish
-
Aug 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Female: form 18 - 75 years old
- Ages
-
18 to 75 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bacterial infections are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
ASST Rhodense, Dipartimento di ginecologia e ostetricia, Viale Forlanini 95
Garbagnate Milanese, Michigan, 20024, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two blood tests may separate real kidney harm from a false alarm
- Can a computer model speed up sepsis blood tests?
- Friendly bacteria vs. vaginal infections: a new trial puts probiotics to the test
- Could a simple blood test curb antibiotic overuse in sick kids?
- Can a simple Self-Test cut preterm births in High-Risk pregnancies?
- New drug CTX-187 takes aim at stubborn bacterial infections