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

NCT04612881 | Unknown

• 1 other identifier: Fitostimoline pessaries
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Bleeding

Outcome Measures

Primary Outcomes (1)

• TSS

  total symptom score (TSS) on a scale from 0 to 10 from worst to best

  60 days

Study Arms (1)

fitostimoline vaginal pessaries

Drug: fitostimoline vaginal pessaries; Other: standard of care

Interventions

fitostimoline vaginal pessaries DRUG

vaginal pessaries

fitostimoline vaginal pessaries

standard of care OTHER

standard of care

fitostimoline vaginal pessaries

Eligibility Criteria

• Age: 30 Years - 80 Years
• Gender Eligibility Details: women
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women aged between 30 and 80 years with hysterctomy.

You may qualify if:

• patient aged between 35 and 80 years
• patient undergoing hysterectomy
• Willingness to understand the procedures and aims of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Barbara Maglione

Napoli, 80123, Italy

RECRUITING

MeSH Terms

Conditions

Uterine Hemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

barbara maglione

CONTACT

+393343293357; barbara.maglione@farmadamor.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 3, 2020
• Study Start: October 18, 2020
• Primary Completion: October 18, 2020
• Study Completion: September 18, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

IT (1)