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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Università degli Studi dell'Insubria.
Recruitment status was:  Recruiting
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
  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.

Resource links provided by NLM:


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

Ages Eligible for Study:   Child, Adult, Senior
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

Locations
Italy
Gynecologic Oncology Unit
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
  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 
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
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on December 02, 2016