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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04612881

Enrollment

Registered

2020-11-03

Start date

2020-10-18

Completion date

2021-09-18

Last updated

2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Bleeding

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.

Interventions

DRUGfitostimoline vaginal pessaries

vaginal pessaries

OTHERstandard of care

standard of care

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 80 Years

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

Design outcomes

Primary

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

Countries

Italy

Contacts

Primary Contactbarbara maglione

barbara.maglione@farmadamor.it+393343293357

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026