NCT02014428

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 18, 2013

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

First QC Date

December 9, 2013

Last Update Submit

December 12, 2013

Conditions

Atrophic Vaginitis

Outcome Measures

Primary Outcomes (1)

  • Atrophic vaginal changes

    Morphometric analysis of biopsies.

    Change from baseline epithelium at 3 months

Secondary Outcomes (3)

  • Assessment of Itching

    Change from baseline Itching at 3 months

  • Assessment of Burning

    Change from baseline Burning at 3 months

  • Assessment of Dyspareunia

    Change from baseline Dyspareunia at 3 months

Study Arms (2)

Hyaluronic acid

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Hyaluronic acidDIETARY_SUPPLEMENT
Hyaluronic acid
PlaceboDRUG
Placebo

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Messina, Italy

Location

MeSH Terms

Conditions

Atrophic Vaginitis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

VaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 18, 2013

Primary Completion

April 1, 2013

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations

IT(1)