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

Phase 4CompletedNCT02014428

AGUNCO Obstetrics and Gynecology Centre

Overview

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

Study Type

INTERVENTIONAL

Conditions

Atrophic Vaginitis

Interventions

Hyaluronic acidDIETARY_SUPPLEMENT

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina.

Messina, Italy

Outcomes

Primary Outcomes

Atrophic vaginal changes

Morphometric analysis of biopsies.

Time frame: Change from baseline epithelium at 3 months

Secondary Outcomes

Assessment of Itching

Scale: absent, mild, moderate, severe.

Time frame: Change from baseline Itching at 3 months

Assessment of Burning

Scale: absent, mild, moderate, severe.

Time frame: Change from baseline Burning at 3 months

Assessment of Dyspareunia

Scale: absent, mild, moderate, severe.

Time frame: Change from baseline Dyspareunia at 3 months

Data from ClinicalTrials.gov

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