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CompletedNCT02014428Updated Dec 18, 2013

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

A Phase 4 interventional study of Hyaluronic acid and Placebo in Atrophic Vaginitis, sponsored by AGUNCO Obstetrics and Gynecology Centre. Completed at 1 site in Italy. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-12-18.

Sponsored by AGUNCO Obstetrics and Gynecology Centre · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Ages
45 Years to 65 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Atrophic Vaginitis

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03

In context

Atrophic Vaginitis

44 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.

Browse Atrophic Vaginitis studies →

Lead sponsor

AGUNCO Obstetrics and Gynecology Centre is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female

Eligibility criteria

Inclusion Criteria:

  • at least 12 months postmenopausal
  • mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.
05

Study design

Phase
Phase 4

Study arms

  • Experimental
    Hyaluronic acid

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

    Dietary Supplement: Hyaluronic acid

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Atrophic vaginal changes

    Morphometric analysis of biopsies.

    Time frame: Change from baseline epithelium at 3 months

Secondary outcomes

  1. Assessment of Itching

    Scale: absent, mild, moderate, severe.

    Time frame: Change from baseline Itching at 3 months

  2. Assessment of Burning

    Scale: absent, mild, moderate, severe.

    Time frame: Change from baseline Burning at 3 months

  3. Assessment of Dyspareunia

    Scale: absent, mild, moderate, severe.

    Time frame: Change from baseline Dyspareunia at 3 months

07

Study locations

1 site
  • Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina.
    Messina, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02014428
Lead sponsor
AGUNCO Obstetrics and Gynecology Centre
Responsible party
Sponsor
First posted
Dec 18, 2013
Primary completion
Apr 2013
Last update
Dec 18, 2013
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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