Saginil in vs. Placebo for Gynecologic Oncology Patients Affected by Vaginitis

NCT ID: NCT01420510

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We hypothesise that the use of Adelmidrol (Saginil in vaginal cannulas) can reduce the incidence and magnitude of vaginitis in patients affected by gynecologic malignancies.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vaginitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adelmidrol

Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients

Group Type EXPERIMENTAL

Adelmidrol vaginal gel

Intervention Type DRUG

Application of a Adelmidrol vaginal gel

Placebo

Efficacy of Placebo in preventing vaginitis in oncologic patients

Group Type PLACEBO_COMPARATOR

Placebo vaginal gel

Intervention Type DRUG

Application of a placebo vaginal gel

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adelmidrol vaginal gel

Application of a Adelmidrol vaginal gel

Intervention Type DRUG

Placebo vaginal gel

Application of a placebo vaginal gel

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Gynecologic malignancy
* Current administration of chemotherapy

Exclusion Criteria

* Colpectomy
* Vaginal cancer
* Vulvar cancer
* Bacterial vaginitis
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fabio Ghezzi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gynecologic Oncology Unit

Varese, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fabio Ghezzi, MD

Role: CONTACT

+390332299309

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fabio Ghezzi, MD

Role: primary

+390332299309

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Saginil in vaginitis

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.