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

NCT ID: NCT04612881

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-18
• Study Completion Date: 2021-09-18

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

fitostimoline vaginal pessaries

fitostimoline vaginal pessaries

Intervention Type: DRUG

vaginal pessaries

standard of care

Intervention Type: OTHER

standard of care

Interventions

fitostimoline vaginal pessaries

vaginal pessaries

Intervention Type: DRUG

standard of care

standard of care

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Michele Vignali

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Barbara Maglione

Napoli, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

barbara maglione

Role: CONTACT

barbara.maglione@farmadamor.it

+393343293357 ext. +393343293357

Facility Contacts

barbara maglione

Role: primary

barbara.maglione@farmadamor.it

+393343293357 ext. +393343293357

Other Identifiers

Fitostimoline pessaries

Identifier Type: -

Identifier Source: org_study_id