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

Vaginal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612881
• Other study ID #: Fitostimoline pessaries
• Status: Recruiting
• Start date: October 18, 2020
• Est. completion date: September 18, 2021

Study information

• Verified date: June 2021
• Source: University of Milan
• Contact: barbara maglione
• Phone: +393343293357
• Email: barbara.maglione[@]farmadamor.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 18, 2021
• Est. primary completion date: October 18, 2020
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Uterine Hemorrhage
• Vaginal Bleeding

Intervention

Drug:
• fitostimoline vaginal pessaries
vaginal pessaries

Other:
• standard of care
standard of care

Locations

Country	Name	City	State
Italy	Barbara Maglione	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TSS	total symptom score (TSS) on a scale from 0 to 10 from worst to best	60 days