Back to resultsHyaluronic Acid and Vaginal Distress
Primary Purpose
Vaginal Disease
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
hyaluronic acid pill
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Disease
Eligibility Criteria
Inclusion Criteria:
- menopause
- vaginal distress
- no other therapy
Exclusion Criteria:
- vaginal infection
- Sjogren Syndrome
Sites / Locations
- Menopause centre of the G. Martino University Policlinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
hyaluroni acid pill
Arm Description
Outcomes
Primary Outcome Measures
effects of the oral somministration hyaluronic acid in menopause women with vaginal distress
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00890487
Brief Title
Hyaluronic Acid and Vaginal Distress
Official Title
Effects of Hyaluronic Acid Oral Supplementation on the Vaginal Epithelium: a Prospective, Randomized, Double-Blind, Placebo Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Messina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to study the effects of the oral supplementation hyaluronic acid in menopause women with vaginal distress for treatment vaginal distress.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hyaluroni acid pill
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
hyaluronic acid pill
Intervention Description
pill, 220 mg, once a day, three months
Primary Outcome Measure Information:
Title
effects of the oral somministration hyaluronic acid in menopause women with vaginal distress
Time Frame
three months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
menopause
vaginal distress
no other therapy
Exclusion Criteria:
vaginal infection
Sjogren Syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tindara LT La Galia, PhD student
Phone
+393470635155
Email
giusy.lagalia@yahoo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tindara TL La Galia, PhD student
Organizational Affiliation
Centre Menopause
Official's Role
Principal Investigator
Facility Information:
Facility Name
Menopause centre of the G. Martino University Policlinic
City
Messina
State/Province
Sicily
ZIP/Postal Code
98100
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tindara TL La Galia, PhD student
Phone
3470635155
Email
giusy.lagalia@yahoo.it
12. IPD Sharing Statement
Learn more about this trial
Hyaluronic Acid and Vaginal Distress
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