NCT00890487

Brief Summary

The purpose of this trial is to study the effects of the oral supplementation hyaluronic acid in menopause women with vaginal distress for treatment vaginal distress.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 29, 2009

Status Verified

April 1, 2009

Enrollment Period

4 months

First QC Date

April 27, 2009

Last Update Submit

April 27, 2009

Conditions

Vaginal Disease

Outcome Measures

Primary Outcomes (1)

  • effects of the oral somministration hyaluronic acid in menopause women with vaginal distress

    three months

Study Arms (1)

hyaluroni acid pill

OTHER
Other: hyaluronic acid pill

Interventions

hyaluronic acid pillOTHER

pill, 220 mg, once a day, three months

hyaluroni acid pill

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • menopause
  • vaginal distress
  • no other therapy

You may not qualify if:

  • vaginal infection
  • Sjogren Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menopause centre of the G. Martino University Policlinic

Messina, Sicily, 98100, Italy

Location

MeSH Terms

Conditions

Vaginal Diseases

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Tindara TL La Galia, PhD student

    Centre Menopause

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tindara LT La Galia, PhD student

CONTACT

+393470635155giusy.lagalia@yahoo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 29, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

April 29, 2009

Record last verified: 2009-04

Locations

IT(1)