Fitostimoline Vaginal Pessaries in Women With Hysterectomy. Randomized, Perspective, Monoscentric Study.
Sponsored by University of Milan
About this trial
Last updated 4 years ago
Study ID
Status
Type
Placebo
Accepting
Trial Timing
Ended 4 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- patient aged between 35 and 80 years
- patient undergoing hysterectomy
- Willingness to understand the procedures and aims of the study
Exclusion Criteria
- Anamnestic or clinical data of metabolic or endocrine diseases (such as uncontrolled diabetes mellitus) or any other local and / or systemic pathology potentially able to interfere with the study parameters;
- Concomitant treatment with antibiotics / antiseptics, NSAIDs, analgesics (excl. Paracetamol)
- Non-therapeutic use of psychoactive substances;
- Abuse of drugs and / or alcohol / smoking;
- Neurological disorders or psychiatric conditions potentially capable of affecting the validity of the consent and / or compromising the patient's adherence to the study procedures;
- Known allergy, hypersensitivity or intolerance to the constituents of the preparations under study;
- Any condition, medical or otherwise, that could significantly reduce the possibility of obtaining reliable data, achieving the objectives of the study, perfecting its completion;
- Presumption of poor reliability or collaboration;
- Treatment with any preparation in the last 30 days prior to the start of the study;
- Patients already enrolled in this study;
- Center staff directly involved in the study and close relatives