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Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness

This study has been completed.
Sponsor:
Collaborator:
Fidia Farmaceutici s.p.a.
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier:
NCT01557179
First received: March 14, 2012
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took place at four centers in China. The primary objective of this study was to assess the efficacy and safety of hyaluronic acid vaginal gel in treating vaginal dryness. In the current study we tested the hypothesis that the efficacy of hyaluronic acid vaginal gel was not inferior to that of estriol cream, with no clinically significant difference between them, in the treatment of vaginal dryness symptoms.


Condition Intervention Phase
The Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal Dryness
 Device: Hyalofemme
Device: Estriol cream (Ovestin)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness. A Multicenter, Randomized, Controlled, Open-label, Parallel-group, Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lee's Pharmaceutical Limited:

Primary Outcome Measures:
  • percentage of improvement of vaginal dryness symptoms [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    percentage of improvement of vaginal dryness symptoms at the baseline and after treatment


Secondary Outcome Measures:
  • percentage of improvement of itching, dyspareunia and burning sensation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    percentage of improvement of itching, dyspareunia and burning sensation at baseline and after treatment


Enrollment: 144
Study Start Date: May 2009
Study Completion Date: May 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyaluronic acid vaginal gel (Hyalofemme)
The treatment in both groups was applied every 3 days for a total of 10 applications. Hyaluronic acid vaginal gel was supplied in a 30g aluminum tube with a vaginal applicator which provides a dose of around 5g
 Device: Hyalofemme
The treatment in both groups was applied every 3 days for a total of 10 applications. Hyaluronic acid vaginal gel was supplied in a 30g aluminum tube with a vaginal applicator which provides a dose of around 5g
Active Comparator: Estriol cream (Ovestin)
The treatment in both groups was applied every 3 days for a total of 10 applications;Estriol cream was supplied in a 15g vial with a prefilled applicator providing a dose of around 0.5 g
 Device: Estriol cream (Ovestin)
The treatment in both groups was applied every 3 days for a total of 10 applications;Estriol cream was supplied in a 15g vial with a prefilled applicator providing a dose of around 0.5 g

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • under 70 years old,
  • had been naturally or surgically postmenopausal for more than 6 months,
  • had symptoms of vaginal dryness due to various causes and had no contraindications to locally applied estrogen

Exclusion Criteria:

  • unmarried, pregnant and breast-feeding women,
  • patients with vaginal infections such as trichomonas,
  • candida and bacterial vaginosis,
  • patients with breast cancer, uterine cancer or estrogen hormone dependent tumors,
  • genital bleeding of unknown origin,
  • patients with acute hepatopathy, embolic disorders,
  • severe primary disease of the kidney and hematopoietic system
  • recent malignant tumors
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT01557179     History of Changes
Other Study ID Numbers: LEES_Hyalofemme_1, Hyalofemme
Study First Received: March 14, 2012
Last Updated: March 16, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013