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Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02014428
Recruitment Status : Completed
First Posted : December 18, 2013
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre

Study Description
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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
Atrophic Vaginitis Dietary Supplement: Hyaluronic acid Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Primary Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Atrophic vaginal changes [ Time Frame: Change from baseline epithelium at 3 months ]
    Morphometric analysis of biopsies.


Secondary Outcome Measures :
  1. Assessment of Itching [ Time Frame: Change from baseline Itching at 3 months ]
    Scale: absent, mild, moderate, severe.

  2. Assessment of Burning [ Time Frame: Change from baseline Burning at 3 months ]
    Scale: absent, mild, moderate, severe.

  3. Assessment of Dyspareunia [ Time Frame: Change from baseline Dyspareunia at 3 months ]
    Scale: absent, mild, moderate, severe.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • at least 12 months postmenopausal
  • mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014428


Locations
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Italy
Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina.
Messina, Italy
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
More Information
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Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT02014428    
Other Study ID Numbers: HA-123
First Posted: December 18, 2013    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Vaginitis
Atrophic Vaginitis
Atrophy
Pathological Conditions, Anatomical
Vaginal Diseases
Hyaluronic Acid
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents