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NCT02014428 Clinical Trial

Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis

Atrophic Vaginitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02014428
Other study ID # HA-123
Secondary ID
Status Completed
Phase Phase 4
First received December 9, 2013
Last updated December 12, 2013

Study information
Verified date December 2013
Source AGUNCO Obstetrics and Gynecology Centre
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date April 2013
Accepts healthy volunteers
Gender Female
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria:

- at least 12 months postmenopausal

- mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Hyaluronic acid

Drug:
• Placebo

Locations
Country Name City State
Italy Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina. Messina

Sponsors (1)
Lead Sponsor Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Atrophic vaginal changes Morphometric analysis of biopsies. Change from baseline epithelium at 3 months
Secondary Assessment of Itching Scale: absent, mild, moderate, severe. Change from baseline Itching at 3 months
Secondary Assessment of Burning Scale: absent, mild, moderate, severe. Change from baseline Burning at 3 months
Secondary Assessment of Dyspareunia Scale: absent, mild, moderate, severe. Change from baseline Dyspareunia at 3 months
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