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

Università degli Studi dell'Insubria

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Vaginitis

Treatments: Drug: Adelmidrol vaginal gel; Drug: Placebo vaginal gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01420510

Saginil in vaginitis

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gynecologic malignancy
• Current administration of chemotherapy

Exclusion criteria

• Colpectomy
• Vaginal cancer
• Vulvar cancer
• Bacterial vaginitis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Adelmidrol

Experimental group

Description:

Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients

Treatment:

Drug: Adelmidrol vaginal gel

Placebo

Placebo Comparator group

Description:

Efficacy of Placebo in preventing vaginitis in oncologic patients

Treatment:

Drug: Placebo vaginal gel