Back to resultsOral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis
Primary Purpose
Atrophic Vaginitis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Hyaluronic acid
Placebo
Sponsored by
About this trial
This is an interventional trial for Atrophic Vaginitis
Eligibility Criteria
Inclusion Criteria:
- at least 12 months postmenopausal
- mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.
Sites / Locations
- Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hyaluronic acid
Placebo
Arm Description
220 mg hyaluronic acid per tablet (two tablets/day for 10 days, and subsequently one tablet/day for three months)
two tablets/day for 10 days, and subsequently one tablet/day for three months
Outcomes
Primary Outcome Measures
Atrophic vaginal changes
Morphometric analysis of biopsies.
Secondary Outcome Measures
Assessment of Itching
Scale: absent, mild, moderate, severe.
Assessment of Burning
Scale: absent, mild, moderate, severe.
Assessment of Dyspareunia
Scale: absent, mild, moderate, severe.
Full Information
NCT ID
NCT02014428
First Posted
December 9, 2013
Last Updated
December 12, 2013
Sponsor
AGUNCO Obstetrics and Gynecology Centre
1. Study Identification
Unique Protocol Identification Number
NCT02014428
Brief Title
Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGUNCO Obstetrics and Gynecology Centre
4. Oversight
5. Study Description
Brief Summary
To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Vaginitis
7. Study Design
Study Phase
Phase 4
8. Arms, Groups, and Interventions
Arm Title
Hyaluronic acid
Arm Type
Experimental
Arm Description
220 mg hyaluronic acid per tablet (two tablets/day for 10 days, and subsequently one tablet/day for three months)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
two tablets/day for 10 days, and subsequently one tablet/day for three months
Intervention Type
Dietary Supplement
Intervention Name(s)
Hyaluronic acid
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Atrophic vaginal changes
Description
Morphometric analysis of biopsies.
Time Frame
Change from baseline epithelium at 3 months
Secondary Outcome Measure Information:
Title
Assessment of Itching
Description
Scale: absent, mild, moderate, severe.
Time Frame
Change from baseline Itching at 3 months
Title
Assessment of Burning
Description
Scale: absent, mild, moderate, severe.
Time Frame
Change from baseline Burning at 3 months
Title
Assessment of Dyspareunia
Description
Scale: absent, mild, moderate, severe.
Time Frame
Change from baseline Dyspareunia at 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
at least 12 months postmenopausal
mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.
Facility Information:
Facility Name
Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina.
City
Messina
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis
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