Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
Sponsor:
Information provided by:
University of Messina
ClinicalTrials.gov Identifier:
NCT00890487
First received: April 27, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose
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 Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00890487

Locations
Italy
Menopause centre of the G. Martino University Policlinic
Messina, Sicily, Italy, 98100
Sponsors and Collaborators
University of Messina
Investigators
Principal Investigator: Tindara TL La Galia, PhD student Centre Menopause
  More Information

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

Additional relevant MeSH terms:
Vaginal Diseases
Genital Diseases, Female
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on December 02, 2016