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Hyaluronic Acid and Vaginal Distress

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by University of Messina.
Recruitment status was:  Not yet recruiting
Information provided by:
University of Messina Identifier:
First received: April 27, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
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 Intervention
Vaginal Disease Other: hyaluronic acid pill

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Messina:

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

Estimated Enrollment: 70
Study Start Date: May 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
hyaluroni acid pill Other: hyaluronic acid pill
pill, 220 mg, once a day, three months


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00890487

Contact: Tindara LT La Galia, PhD student +393470635155

Menopause centre of the G. Martino University Policlinic Not yet recruiting
Messina, Sicily, Italy, 98100
Contact: Tindara TL La Galia, PhD student    3470635155   
Sponsors and Collaborators
University of Messina
Principal Investigator: Tindara TL La Galia, PhD student Centre Menopause
  More Information

Responsible Party: G.Marino University Policlinic of Messina, Menopause centre of Identifier: NCT00890487     History of Changes
Other Study ID Numbers: 30031978
Study First Received: April 27, 2009
Last Updated: April 27, 2009

Additional relevant MeSH terms:
Vaginal Diseases
Genital Diseases, Female
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents processed this record on September 21, 2017