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

Phase 3UnknownNCT01420510

Università degli Studi dell'Insubria60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Vaginitis

Interventions

Adelmidrol vaginal gelDRUG

Application of a Adelmidrol vaginal gel

Placebo vaginal gelDRUG

Application of a placebo vaginal gel

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Gynecologic malignancy * Current administration of chemotherapy Exclusion Criteria: * Colpectomy * Vaginal cancer * Vulvar cancer * Bacterial vaginitis

Locations (1)

Gynecologic Oncology Unit

Varese, Italy

RECRUITING

Outcomes

Primary Outcomes

Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group

Time frame: 2 months

Central Contacts

Fabio Ghezzi, MD

CONTACT

+390332299309 fabio.ghezzi@uninsubria.it

Data from ClinicalTrials.gov

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