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

Phase 4

Completed

• Conditions: Atrophic Vaginitis
• Interventions: Dietary Supplement: Hyaluronic acid; Drug: Placebo

• Registration Number: NCT02014428
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Primary Completion: 2013-04
• Status Verified: 2013-12
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-12
• Last Update Submitted: 2013-12-12
• Study First Posted: 2013-12-18
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• at least 12 months postmenopausal
• mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid	Hyaluronic acid	220 mg hyaluronic acid per tablet (two tablets/day for 10 days, and subsequently one tablet/day for three months)
Placebo	Placebo	two tablets/day for 10 days, and subsequently one tablet/day for three months

Primary Outcome Measures

Name	Time	Method
Atrophic vaginal changes	Change from baseline epithelium at 3 months	Morphometric analysis of biopsies.

Secondary Outcome Measures

Name	Time	Method
Assessment of Dyspareunia	Change from baseline Dyspareunia at 3 months	Scale: absent, mild, moderate, severe.
Assessment of Itching	Change from baseline Itching at 3 months	Scale: absent, mild, moderate, severe.
Assessment of Burning	Change from baseline Burning at 3 months	Scale: absent, mild, moderate, severe.

Trial Locations

Locations (1)

Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina.; 🇮🇹 Messina, Italy