Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis

December 12, 2013 updated by: AGUNCO Obstetrics and Gynecology Centre
To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Messina, Italy
        • Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • at least 12 months postmenopausal
  • mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic acid
220 mg hyaluronic acid per tablet (two tablets/day for 10 days, and subsequently one tablet/day for three months)
Placebo Comparator: Placebo
two tablets/day for 10 days, and subsequently one tablet/day for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrophic vaginal changes
Time Frame: Change from baseline epithelium at 3 months
Morphometric analysis of biopsies.
Change from baseline epithelium at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Itching
Time Frame: Change from baseline Itching at 3 months
Scale: absent, mild, moderate, severe.
Change from baseline Itching at 3 months
Assessment of Burning
Time Frame: Change from baseline Burning at 3 months
Scale: absent, mild, moderate, severe.
Change from baseline Burning at 3 months
Assessment of Dyspareunia
Time Frame: Change from baseline Dyspareunia at 3 months
Scale: absent, mild, moderate, severe.
Change from baseline Dyspareunia at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 12, 2013

First Posted (Estimate)

December 18, 2013

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

December 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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