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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT02014428
First received: December 9, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.


Condition Intervention Phase
Atrophic Vaginitis
Dietary Supplement: Hyaluronic acid
Drug: Placebo
Phase 4

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

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


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

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

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


Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014428

Locations
Italy
Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina.
Messina, Italy
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
  More Information

No publications provided

Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT02014428     History of Changes
Other Study ID Numbers: HA-123
Study First Received: December 9, 2013
Last Updated: December 12, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Vaginitis
Atrophic Vaginitis
Atrophy
Vaginal Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014