Hyaluronic Acid and Vaginal Distress

• Sponsor: University of Messina (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00890487
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arm: 1
• Duration (Months): 7
• Patients Per Site Per Month: 10

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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 1, 2009
• Anticipated Primary Completion Date: Sep 1, 2009
• Anticipated Study Completion Date: Dec 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. effects of the oral somministration hyaluronic acid in menopause women with vaginal distress [three months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00890487
• Other Study ID Numbers: 30031978
• First Posted: Apr 29, 2009
• Last Update Posted: Apr 29, 2009
• Last Verified: Apr 1, 2009

• Additional relevant MeSH terms: Vaginal Diseases; Hyaluronic Acid

Study Results

No Results Posted as of Apr 29, 2009