Vaginal DiseaseNCT00890487
Hyaluronic Acid and Vaginal Distress
A study testing hyaluronic acid pill in people with Vaginal Disease, run by University of Messina at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Disease
- What is being tested?
- hyaluronic acid pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- menopause
- vaginal distress
- no other therapy
Who cannot join
- vaginal infection
- Sjogren Syndrome
Trial locations and contacts
1 site in 1 country.
Italy1 site
Menopause centre of the G. Martino University Policlinic
Messina, Sicily, 98100
Tindara TL La Galia, PhD student, 3470635155, giusy.lagalia@yahoo.it
About this study
Official title: Effects of Hyaluronic Acid Oral Supplementation on the Vaginal Epithelium: a Prospective, Randomized, Double-Blind, Placebo Controlled Study
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.
- Conditions
- Vaginal Disease
- Being tested
- hyaluronic acid pill
- Medical subject headings
- Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acid pillOther
pill, 220 mg, once a day, three months
| Study group | Role | What they receive |
|---|---|---|
| hyaluroni acid pill | Other | Not described Receives: Other: hyaluronic acid pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
effects of the oral somministration hyaluronic acid in menopause women with vaginal distress
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Investigators
- Tindara TL La Galia, PhD student, Principal investigator, Centre Menopause
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890487
- Sponsor's protocol ID
- 30031978
- Status last verified
- Apr 2009
- First submitted
- 27 Apr 2009
- Last updated
- 29 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hyaluronic Acid Oral Supplementation on the Vaginal Epithelium: a Prospective, Randomized, Double-Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00890487
- Acronym / sponsor ID
- 30031978
- Conditions
- Vaginal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyaluroni acid pill | Other | Other: hyaluronic acid pill |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- menopause
- vaginal distress
- no other therapy
Key exclusion criteria (2 listed)
- vaginal infection
- Sjogren Syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyaluronic acid pillpill, 220 mg, once a day, three months | Other | hyaluroni acid pill |
Primary outcome
effects of the oral somministration hyaluronic acid in menopause women with vaginal distress
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tindara TL La Galia, PhD student principal investigator
Centre Menopause
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyaluronic acid pill in people with Vaginal Disease, run by University of Messina at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tindara LT La Galia, PhD student (+393470635155, giusy.lagalia@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects of the oral somministration hyaluronic acid in menopause women with vaginal distress (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2009.