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

NCT ID: NCT02014428

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Atrophic Vaginitis

Study Groups

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Hyaluronic acid

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

Group Type EXPERIMENTAL

Hyaluronic acid

Intervention Type DIETARY_SUPPLEMENT

Placebo

two tablets/day for 10 days, and subsequently one tablet/day for three months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Hyaluronic acid

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AGUNCO Obstetrics and Gynecology Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Messina, , Italy

Site Status

Countries

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Italy

Other Identifiers

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HA-123

Identifier Type: -

Identifier Source: org_study_id