- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02014428
Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis
December 12, 2013 updated by: AGUNCO Obstetrics and Gynecology Centre
To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Messina, Italy
- Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- at least 12 months postmenopausal
- mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hyaluronic acid
220 mg hyaluronic acid per tablet (two tablets/day for 10 days, and subsequently one tablet/day for three months)
|
|
Placebo Comparator: Placebo
two tablets/day for 10 days, and subsequently one tablet/day for three months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Atrophic vaginal changes
Time Frame: Change from baseline epithelium at 3 months
|
Morphometric analysis of biopsies.
|
Change from baseline epithelium at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Itching
Time Frame: Change from baseline Itching at 3 months
|
Scale: absent, mild, moderate, severe.
|
Change from baseline Itching at 3 months
|
Assessment of Burning
Time Frame: Change from baseline Burning at 3 months
|
Scale: absent, mild, moderate, severe.
|
Change from baseline Burning at 3 months
|
Assessment of Dyspareunia
Time Frame: Change from baseline Dyspareunia at 3 months
|
Scale: absent, mild, moderate, severe.
|
Change from baseline Dyspareunia at 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
December 9, 2013
First Submitted That Met QC Criteria
December 12, 2013
First Posted (Estimate)
December 18, 2013
Study Record Updates
Last Update Posted (Estimate)
December 18, 2013
Last Update Submitted That Met QC Criteria
December 12, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HA-123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrophic Vaginitis
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Fayoum UniversityRecruitingAtrophic Vaginitis | Postmenopausal Atrophic VaginitisEgypt
-
Amneal Pharmaceuticals, LLCCompletedAtrophic Vaginitis Due to MenopauseUnited States
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First Affiliated Hospital, Sun Yat-Sen UniversityUnknownAtrophic VaginitisChina
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Wyeth is now a wholly owned subsidiary of PfizerCompletedAtrophic VaginitisUnited States
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Alvogen Pine Brook LLCCompleted
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Actavis Inc.Teva Pharmaceuticals USACompletedAtrophic VaginitisUnited States
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Maire Mac BrideNational Center for Advancing Translational Sciences (NCATS)TerminatedAtrophic VaginitisUnited States
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