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

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

Sponsors

Lead Sponsor: Università degli Studi dell'Insubria

Source Università degli Studi dell'Insubria
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.

Overall Status Unknown status
Start Date September 2011
Completion Date December 2014
Primary Completion Date November 2014
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group 2 months
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Adelmidrol vaginal gel

Description: Application of a Adelmidrol vaginal gel

Arm Group Label: Adelmidrol

Intervention Type: Drug

Intervention Name: Placebo vaginal gel

Description: Application of a placebo vaginal gel

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- Gynecologic malignancy

- Current administration of chemotherapy

Exclusion Criteria:

- Colpectomy

- Vaginal cancer

- Vulvar cancer

- Bacterial vaginitis

Gender: Female

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Fabio Ghezzi, MD

Phone: +390332299309

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Gynecologic Oncology Unit Fabio Ghezzi, MD +390332299309 [email protected] Fabio Ghezzi, MD Principal Investigator
Location Countries

Italy

Verification Date

June 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Università degli Studi dell'Insubria

Investigator Full Name: Fabio Ghezzi

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Adelmidrol

Type: Experimental

Description: Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients

Label: Placebo

Type: Placebo Comparator

Description: Efficacy of Placebo in preventing vaginitis in oncologic patients

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov