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Saginil vs. Placebo for Gynecologic Oncology Patients Affected by Vaginitis

This study is not yet open for participant recruitment.
Verified July 2011 by Università degli Studi dell'Insubria
Sponsor:
Information provided by:
Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT01420510
First received: August 16, 2011
Last updated: August 18, 2011
Last verified: July 2011
History of Changes
  Purpose

We hypothesise that the use of Palmitoylethanolamide can reduce the incidence and magnitude of vaginitis in patients affected by gynecologic malignancies.


Condition Intervention Phase
Vaginitis
 Drug: Palmitoylethanolamide vaginal cream
Drug: Placebo vaginal cream
 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

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

Primary Outcome Measures:
  • Number of patients with vaginitis in the group taking Palmitoylethanolamide 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: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palmitoylethanolamide
Efficacy of Palmitoylethanolamide in preventing vaginitis in oncologic patients
 Drug: Palmitoylethanolamide vaginal cream
Application of a Palmitoylethanolamide vaginal cream
Placebo Comparator: Placebo
Efficacy of Placebo in preventing vaginitis in oncologic patients
 Drug: Placebo vaginal cream
Application of a placebo vaginal cream

  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
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 Not yet 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, 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: August 18, 2011
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Palmidrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013