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NCT01420510 Clinical Trial

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

Vaginitis Clinical Trial

Official title:
Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01420510
Other study ID # Saginil in vaginitis
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received August 16, 2011
Last updated June 20, 2013
Start date September 2011
Est. completion date December 2014

Study information
Verified date June 2013
Source Università degli Studi dell'Insubria
Contact Fabio Ghezzi, MD
Phone +390332299309
Email fabio.ghezzi@uninsubria.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Gynecologic malignancy

- Current administration of chemotherapy

Exclusion Criteria:

- Colpectomy

- Vaginal cancer

- Vulvar cancer

- Bacterial vaginitis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Adelmidrol vaginal gel
Application of a Adelmidrol vaginal gel
• Placebo vaginal gel
Application of a placebo vaginal gel

Locations
Country Name City State
Italy Gynecologic Oncology Unit Varese

Sponsors (1)
Lead Sponsor Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group 2 months Yes
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