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

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ClinicalTrials.gov Identifier: NCT01420510
Recruitment Status : Unknown
Verified June 2013 by Fabio Ghezzi, Università degli Studi dell'Insubria.
Recruitment status was:  Recruiting
First Posted : August 19, 2011
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
Fabio Ghezzi, Università degli Studi dell'Insubria

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vaginitis Drug: Adelmidrol vaginal gel Drug: Placebo vaginal gel Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : September 2011
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Fabio Ghezzi, Professor, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT01420510     History of Changes
Other Study ID Numbers: Saginil in vaginitis
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013

Keywords provided by Fabio Ghezzi, Università degli Studi dell'Insubria:
Patients satisfaction
Side effects

Additional relevant MeSH terms:
Vaginitis
Vaginal Diseases
Genital Diseases, Female