Vaginal BleedingNCT04612881
Fitostimoline Vaginal Pessaries in Women With Hysterectomy. Randomized, Perspective, Monoscentric Study.
An observational study of Vaginal Bleeding, run by University of Milan at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Vaginal Bleeding
- What is being tested?
- fitostimoline vaginal pessaries
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 18 Oct 2020to 18 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Women only
- Adult, Older adult
Study population: women aged between 30 and 80 years with hysterctomy.
Who may be able to join
- patient aged between 35 and 80 years
- patient undergoing hysterectomy
- Willingness to understand the procedures and aims of the study
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Barbara Maglione
Naples, 80123
barbara maglione, +393343293357 ext. +393343293357, barbara.maglione@farmadamor.it
About this study
Official title: 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.
- Conditions
- Vaginal Bleeding
- Being tested
- fitostimoline vaginal pessaries, standard of care
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fitostimoline vaginal pessariesDrug
vaginal pessaries
standard of careOther
standard of care
| Study group | Role | What they receive |
|---|---|---|
| fitostimoline vaginal pessaries | Not described Receives: Drug: fitostimoline vaginal pessaries; Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
TSS
total symptom score (TSS) on a scale from 0 to 10 from worst to best
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start18 Oct 2020
- Primary completion18 Oct 2020
- Study completion18 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Vignali, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612881
- Sponsor's protocol ID
- Fitostimoline pessaries
- Status last verified
- Jun 2021
- First submitted
- 27 Oct 2020
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Verification of the Activity and Tolerability of Fitostimoline Vaginal Pessaries in Women With Hysterectomy. Randomized, Perspective, Monoscentric Study.
- ClinicalTrials.gov ID
- NCT04612881
- Acronym / sponsor ID
- Fitostimoline pessaries
- Conditions
- Vaginal Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 18 Oct 2020 (actual)
- Primary completion
- 18 Oct 2020 (actual)
- Study completion
- 18 Sep 2021 (estimated)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fitostimoline vaginal pessaries | – | Drug: fitostimoline vaginal pessaries, Other: standard of care |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- women aged between 30 and 80 years with hysterctomy.
Key inclusion criteria (3 listed)
- patient aged between 35 and 80 years
- patient undergoing hysterectomy
- Willingness to understand the procedures and aims of the study
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fitostimoline vaginal pessariesvaginal pessaries | Drug | fitostimoline vaginal pessaries |
| standard of carestandard of care | Other | fitostimoline vaginal pessaries |
Primary outcome
TSS
Time frame: 60 days
total symptom score (TSS) on a scale from 0 to 10 from worst to best
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Bleeding, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact barbara maglione (+393343293357 ext. +393343293357, barbara.maglione@farmadamor.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TSS (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.