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NCT00890487 Clinical Trial

Hyaluronic Acid and Vaginal Distress

Vaginal Disease Clinical Trial

Official title:
Effects of Hyaluronic Acid Oral Supplementation on the Vaginal Epithelium: a Prospective, Randomized, Double-Blind, Placebo Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00890487
Other study ID # 30031978
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 27, 2009
Last updated April 27, 2009
Start date May 2009
Est. completion date December 2009

Study information
Verified date April 2009
Source University of Messina
Contact Tindara LT La Galia, PhD student
Phone +393470635155
Email giusy.lagalia@yahoo.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 70
Est. completion date December 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 60 Years
Eligibility Inclusion Criteria:

- menopause

- vaginal distress

- no other therapy

Exclusion Criteria:

- vaginal infection

- Sjogren Syndrome

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• hyaluronic acid pill
pill, 220 mg, once a day, three months

Locations
Country Name City State
Italy Menopause centre of the G. Martino University Policlinic Messina Sicily

Sponsors (1)
Lead Sponsor Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary effects of the oral somministration hyaluronic acid in menopause women with vaginal distress three months Yes
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