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Hyaluronic Acid and Vaginal Distress

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ClinicalTrials.gov 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
Sponsor:
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

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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00890487


Contacts
Contact: Tindara LT La Galia, PhD student +393470635155 giusy.lagalia@yahoo.it

Locations
Italy
Menopause centre of the G. Martino University Policlinic Not yet recruiting
Messina, Sicily, Italy, 98100
Contact: Tindara TL La Galia, PhD student    3470635155    giusy.lagalia@yahoo.it   
Sponsors and Collaborators
University of Messina
Investigators
Principal Investigator: Tindara TL La Galia, PhD student Centre Menopause

Responsible Party: G.Marino University Policlinic of Messina, Menopause centre of
ClinicalTrials.gov Identifier: NCT00890487     History of Changes
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:
Vaginal Diseases
Genital Diseases, Female
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents