Saginil in vs. Placebo for Gynecologic Oncology Patients... | NCT01420510

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

NCT01420510

Sponsor

Università degli Studi dell'Insubria

Status

Unknown status

Last Update Posted

Jun 21, 2013Estimated

Enrollment

60Estimated

Phase

Phase 2Phase 3

Conditions

Vaginitis

Interventions

Adelmidrol vaginal gel
Placebo vaginal gel

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Nov 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Aug 16, 2011

First Submission Date that Met QC Criteria

Aug 18, 2011

First Posted Date

Aug 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2013

Last Update Posted Date

Jun 21, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fabio Ghezzi, Professor, Università degli Studi dell'InsubriaPrincipal Investigator

Lead Sponsor

Università degli Studi dell'InsubriaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adelmidrol	Experimental	Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients	Drug: Adelmidrol vaginal gel
Placebo	Placebo Comparator	Efficacy of Placebo in preventing vaginitis in oncologic patients	Drug: Placebo vaginal gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adelmidrol vaginal gel	Drug	Application of a Adelmidrol vaginal gel	Adelmidrol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gynecologic malignancy
Current administration of chemotherapy

Exclusion Criteria:

Colpectomy
Vaginal cancer
Vulvar cancer
Bacterial vaginitis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fabio Ghezzi, MD	Contact	+390332299309		fabio.ghezzi@uninsubria.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gynecologic Oncology Unit	Recruiting	Varese		21100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D014627	Vaginitis

Ancestor Terms

ID	Term
D014623	Vaginal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided