Hyaluronic Acid and Vaginal Distress

April 27, 2009 updated by: University of Messina

Effects of Hyaluronic Acid Oral Supplementation on the Vaginal Epithelium: a Prospective, Randomized, Double-Blind, Placebo Controlled Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
    • Sicily
      • Messina, Sicily, Italy, 98100
        • Menopause centre of the G. Martino University Policlinic
        • Contact:

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

43 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • menopause
  • vaginal distress
  • no other therapy

Exclusion Criteria:

  • vaginal infection
  • Sjogren Syndrome

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: hyaluroni acid pill
Other: hyaluronic acid pill
pill, 220 mg, once a day, three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
effects of the oral somministration hyaluronic acid in menopause women with vaginal distress
Time Frame: three months
three months

Collaborators and Investigators

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

Sponsor

University of Messina

Investigators

  • Principal Investigator: Tindara TL La Galia, PhD student, Centre Menopause

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

Study Start

May 1, 2009

Primary Completion (Anticipated)

September 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimate)

April 29, 2009

Study Record Updates

Last Update Posted (Estimate)

April 29, 2009

Last Update Submitted That Met QC Criteria

April 27, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30031978

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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