Fitostimoline Vaginal Pessaries in Women With Hysterectomy. Randomized, Perspective, Monoscentric Study.

• Conditions: Vaginal Bleeding
• Interventions: Drug: fitostimoline vaginal pessaries; Other: standard of care

• Registration Number: NCT04612881
• Lead Sponsor: University of Milan

Brief Summary

Clinical evaluation of Fitostimoline vaginal pessaries in the treatment of hysterectomy. An observational, randomized, perspective study performed on 60 women where 30 women are treated with fitostimoline pessaries and 30 women are treated with the standard of care.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-18
• Primary Completion: 2020-10-18
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-03
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-21
• Study Completion: 2021-09-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fitostimoline vaginal pessaries	fitostimoline vaginal pessaries	-
fitostimoline vaginal pessaries	standard of care	-

Primary Outcome Measures

Name	Time	Method
TSS	60 days	total symptom score (TSS) on a scale from 0 to 10 from worst to best

Trial Locations

Locations (1)

Barbara Maglione; 🇮🇹 Napoli, Italy