NCT01420510

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

3.2 years

First QC Date

August 16, 2011

Last Update Submit

June 20, 2013

Conditions

Vaginitis

Keywords

Patients satisfactionSide effects

Outcome Measures

Primary Outcomes (1)

  • Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group

    2 months

Study Arms (2)

Adelmidrol

EXPERIMENTAL

Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients

Drug: Adelmidrol vaginal gel

Placebo

PLACEBO COMPARATOR

Efficacy of Placebo in preventing vaginitis in oncologic patients

Drug: Placebo vaginal gel

Interventions

Adelmidrol vaginal gelDRUG

Application of a Adelmidrol vaginal gel

Adelmidrol
Placebo vaginal gelDRUG

Application of a placebo vaginal gel

Placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Gynecologic malignancy
  • Current administration of chemotherapy

You may not qualify if:

  • Colpectomy
  • Vaginal cancer
  • Vulvar cancer
  • Bacterial vaginitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Unit

Varese, 21100, Italy

RECRUITING

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Fabio Ghezzi, MD

CONTACT

+390332299309fabio.ghezzi@uninsubria.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 19, 2011

Study Start

September 1, 2011

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations

IT(1)