Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial.
Phase 2/Phase 3
N/A
N/A
N/A
N/A
Open (Enrolling)
Female
Vaginitis
Female
Vaginitis
Trial Information
Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial.
Inclusion Criteria:
- Gynecologic malignancy
- Current administration of chemotherapy
Exclusion Criteria:
- Colpectomy
- Vaginal cancer
- Vulvar cancer
- Bacterial vaginitis
Type of Study:
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
Outcome Measure:
Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group
Outcome Time Frame:
2 months
Safety Issue:
Yes
Authority:
Italy: Ethics Committee
Study ID:
Saginil in vaginitis
NCT ID:
NCT01420510
Start Date:
September 2011
Completion Date:
December 2014
Related Keywords:
- Vaginitis
- Patients satisfaction
- Side effects
- Vaginitis
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