Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis
Sponsor
AGUNCO Obstetrics and Gynecology Centre (Other)
Overall Status
Completed
CT.gov ID
NCT02014428
Collaborator
(none)
1
2
Study Details
Study Description
Brief Summary
To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Primary Completion Date
:
Apr 1, 2013
Arms and Interventions
| 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) |
Dietary Supplement: Hyaluronic acid
|
| Placebo Comparator: Placebo two tablets/day for 10 days, and subsequently one tablet/day for three months |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Atrophic vaginal changes [Change from baseline epithelium at 3 months]
Morphometric analysis of biopsies.
Secondary Outcome Measures
- Assessment of Itching [Change from baseline Itching at 3 months]
Scale: absent, mild, moderate, severe.
- Assessment of Burning [Change from baseline Burning at 3 months]
Scale: absent, mild, moderate, severe.
- Assessment of Dyspareunia [Change from baseline Dyspareunia at 3 months]
Scale: absent, mild, moderate, severe.
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
to 65 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
-
at least 12 months postmenopausal
-
mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina. | Messina | Italy |
Sponsors and Collaborators
- AGUNCO Obstetrics and Gynecology Centre
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT02014428
Other Study ID Numbers:
- HA-123
First Posted:
Dec 18, 2013
Last Update Posted:
Dec 18, 2013
Last Verified:
Dec 1, 2013