NCT01420510UnknownPhase 2
Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial.
Università degli Studi dell'Insubria1 site in 1 country60 target enrollmentStarted: September 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Gynecologic malignancy
- •Current administration of chemotherapy
Exclusion Criteria
- •Colpectomy
- •Vaginal cancer
- •Vulvar cancer
- •Bacterial vaginitis
Arms & Interventions
Adelmidrol
Experimental
Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients
Intervention: Adelmidrol vaginal gel (Drug)
Placebo
Placebo Comparator
Efficacy of Placebo in preventing vaginitis in oncologic patients
Intervention: Placebo vaginal gel (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Fabio Ghezzi
Professor
Università degli Studi dell'Insubria
Study Sites (1)
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