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Hyaluronic Acid and Vaginal Distress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00890487
Recruitment Status : Unknown
Verified April 2009 by University of Messina.
Recruitment status was:  Not yet recruiting
First Posted : April 29, 2009
Last Update Posted : April 29, 2009
Information provided by:
University of Messina

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.

Condition or disease Intervention/treatment Phase
Vaginal Disease Other: hyaluronic acid pill Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Hyaluronic Acid Oral Supplementation on the Vaginal Epithelium: a Prospective, Randomized, Double-Blind, Placebo Controlled Study
Study Start Date : May 2009
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. effects of the oral somministration hyaluronic acid in menopause women with vaginal distress [ Time Frame: three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • menopause
  • vaginal distress
  • no other therapy

Exclusion Criteria:

  • vaginal infection
  • Sjogren Syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00890487

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Contact: Tindara LT La Galia, PhD student +393470635155

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Menopause centre of the G. Martino University Policlinic
Messina, Sicily, Italy, 98100
Contact: Tindara TL La Galia, PhD student    3470635155   
Sponsors and Collaborators
University of Messina
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Principal Investigator: Tindara TL La Galia, PhD student Centre Menopause
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Responsible Party: G.Marino University Policlinic of Messina, Menopause centre of Identifier: NCT00890487    
Other Study ID Numbers: 30031978
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Vaginal Diseases
Genital Diseases, Female
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents