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

Phase 2

• Conditions: Vaginitis
• Interventions: Drug: Adelmidrol vaginal gel; Drug: Placebo vaginal gel

• Registration Number: NCT01420510
• Lead Sponsor: Università degli Studi dell'Insubria

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-19
• Study Start: 2011-09
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-21
• Primary Completion: 2014-11
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Gynecologic malignancy
• Current administration of chemotherapy

Exclusion Criteria

• Colpectomy
• Vaginal cancer
• Vulvar cancer
• Bacterial vaginitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adelmidrol	Adelmidrol vaginal gel	Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients
Placebo	Placebo vaginal gel	Efficacy of Placebo in preventing vaginitis in oncologic patients

Primary Outcome Measures

Name	Time	Method
Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group	2 months

Trial Locations

Locations (1)

Gynecologic Oncology Unit; 🇮🇹 Varese, Italy