Atrophic VaginitisPhase 4NCT02014428
Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis
A Phase 4 study testing Hyaluronic acid in people with Atrophic Vaginitis, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
Trial summary
To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Atrophic Vaginitis
- What is being tested?
- Hyaluronic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento Apr 2013
- Phase
- Phase 4
- 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 65 years
- Women only
- Adult, Older adult
Who may be able to join
- at least 12 months postmenopausal
- mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina.
Messina
About this study
To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.
- Conditions
- Atrophic Vaginitis
- Being tested
- Hyaluronic acid, Placebo
- Medical subject headings
- Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDietary supplement
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Experimental | 220 mg hyaluronic acid per tablet (two tablets/day for 10 days, and subsequently one tablet/day for three months) Receives: Dietary Supplement: Hyaluronic acid |
| Placebo | Placebo comparator | two tablets/day for 10 days, and subsequently one tablet/day for three months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrophic vaginal changes
Morphometric analysis of biopsies.
Measured: Change from baseline epithelium at 3 months
Secondary outcomes (3)
Assessment of Itching
Scale: absent, mild, moderate, severe.
Measured: Change from baseline Itching at 3 months
Assessment of Burning
Scale: absent, mild, moderate, severe.
Measured: Change from baseline Burning at 3 months
Assessment of Dyspareunia
Scale: absent, mild, moderate, severe.
Measured: Change from baseline Dyspareunia at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Primary completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic VaginitisStudies 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 4
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014428
- Sponsor's protocol ID
- HA-123
- Status last verified
- Dec 2013
- First submitted
- 9 Dec 2013
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis
- ClinicalTrials.gov ID
- NCT02014428
- Acronym / sponsor ID
- HA-123
- Conditions
- Atrophic Vaginitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- Primary completion
- Apr 2013 (actual)
- First posted
- 18 Dec 2013 (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.
To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Experimental | Dietary Supplement: Hyaluronic acid220 mg hyaluronic acid per tablet (two tablets/day for 10 days, and subsequently one tablet/day for three months) |
| Placebo | Placebo comparator | Drug: Placebotwo tablets/day for 10 days, and subsequently one tablet/day for three months |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 12 months postmenopausal
- mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.
Key exclusion criteria (0 listed)
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 | Dietary supplement | Hyaluronic acid |
| Placebo | Drug | Placebo |
Primary outcome
Atrophic vaginal changes
Time frame: Change from baseline epithelium at 3 months
Morphometric analysis of biopsies.
3 secondary outcomes
Assessment of Itching
Time frame: Change from baseline Itching at 3 months
Assessment of Burning
Time frame: Change from baseline Burning at 3 months
Assessment of Dyspareunia
Time frame: Change from baseline Dyspareunia at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
Related trials for Atrophic Vaginitis
Recruiting
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Not yet recruitingPhase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic Vaginitis, Vaginal Atrophy
Active, not recruiting
LASER and Radiofrequency and Genitourinary Syndrome of Menopause
Postmenopausal Atrophic Vaginitis, Postmenopausal Symptoms
Not yet recruitingPhase 4
Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Post-menopausal Women
Postmenopausal Atrophic Vaginitis, Genitourinary Syndrome of Menopause
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic acid in people with Atrophic Vaginitis, run by AGUNCO Obstetrics and Gynecology Centre 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 2 inclusion and 0 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: finished, as of the sponsor's last update on 18 Dec 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrophic vaginal changes (time frame: Change from baseline epithelium at 3 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 18 Dec 2013.