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

Clinical Verification of the Activity and Tolerability of Fitostimoline Vaginal Pessaries in Women With Hysterectomy. Randomized, Perspective, Monoscentric Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Bleeding
• Intervention / Treatment: Drug: fitostimoline vaginal pessaries; Other: standard of care

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80123
    • Recruiting
    • Barbara Maglione

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women aged between 30 and 80 years with hysterctomy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
fitostimoline vaginal pessaries	Drug: fitostimoline vaginal pessaries; vaginal pessaries; Other: standard of care; standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TSS	total symptom score (TSS) on a scale from 0 to 10 from worst to best	60 days

Collaborators and Investigators

• Sponsor: University of Milan

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2020
• Primary Completion (Actual): October 18, 2020
• Study Completion (Anticipated): September 18, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: Fitostimoline pessaries

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No