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

Primary Purpose

Vaginitis

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Adelmidrol vaginal gel

Placebo vaginal gel

About this trial

This is an interventional prevention trial for Vaginitis focused on measuring Patients satisfaction, Side effects

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Gynecologic malignancy
Current administration of chemotherapy

Exclusion Criteria:

Colpectomy
Vaginal cancer
Vulvar cancer
Bacterial vaginitis

Sites / Locations

Gynecologic Oncology UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Adelmidrol

Placebo

Arm Description

Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients

Efficacy of Placebo in preventing vaginitis in oncologic patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01420510

First Posted

August 16, 2011

Last Updated

June 20, 2013

Sponsor

Università degli Studi dell'Insubria

1. Study Identification

Unique Protocol Identification Number

NCT01420510

Brief Title

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

Official Title

Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

November 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Università degli Studi dell'Insubria

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginitis

Keywords

Patients satisfaction, Side effects

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adelmidrol

Arm Type

Experimental

Arm Description

Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Efficacy of Placebo in preventing vaginitis in oncologic patients

Intervention Type

Drug

Intervention Name(s)

Adelmidrol vaginal gel

Intervention Description

Application of a Adelmidrol vaginal gel

Intervention Type

Drug

Intervention Name(s)

Placebo vaginal gel

Intervention Description

Application of a placebo vaginal gel

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fabio Ghezzi, MD

Phone

+390332299309

fabio.ghezzi@uninsubria.it

Facility Information:

Facility Name

Gynecologic Oncology Unit

City

Varese

ZIP/Postal Code

21100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fabio Ghezzi, MD

Phone

+390332299309

fabio.ghezzi@uninsubria.it

First Name & Middle Initial & Last Name & Degree

Fabio Ghezzi, MD

12. IPD Sharing Statement

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

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