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

This study is currently recruiting participants. (see Contacts and Locations)

Verified June 2013 by Università degli Studi dell'Insubria

Sponsor:

Information provided by (Responsible Party):

Fabio Ghezzi, Università degli Studi dell'Insubria

ClinicalTrials.gov Identifier:

NCT01420510

First received: August 16, 2011

Last updated: June 20, 2013

Last verified: June 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Vaginitis	Drug: Adelmidrol vaginal gel Drug: Placebo vaginal gel	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial.

Further study details as provided by Università degli Studi dell'Insubria:

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 [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	60
Study Start Date:	September 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Adelmidrol Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients	Drug: Adelmidrol vaginal gel Application of a Adelmidrol vaginal gel
Placebo Comparator: Placebo Efficacy of Placebo in preventing vaginitis in oncologic patients	Drug: Placebo vaginal gel Application of a placebo vaginal gel

Eligibility


Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Gynecologic malignancy
Current administration of chemotherapy

Exclusion Criteria:

Colpectomy
Vaginal cancer
Vulvar cancer
Bacterial vaginitis

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420510

Contacts


Contact: Fabio Ghezzi, MD	+390332299309	fabio.ghezzi@uninsubria.it

Locations


Italy
Gynecologic Oncology Unit	Recruiting
Varese, Italy, 21100
Contact: Fabio Ghezzi, MD +390332299309 fabio.ghezzi@uninsubria.it
Principal Investigator: Fabio Ghezzi, MD

Sponsors and Collaborators

Università degli Studi dell'Insubria

More Information

No publications provided


Responsible Party:	Fabio Ghezzi, Professor, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:	NCT01420510 History of Changes
Other Study ID Numbers:	Saginil in vaginitis
Study First Received:	August 16, 2011
Last Updated:	June 20, 2013
Health Authority:	Italy: Ethics Committee

Keywords provided by Università degli Studi dell'Insubria:


Patients satisfaction Side effects

Additional relevant MeSH terms:


Vaginitis Genital Diseases, Female Vaginal Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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