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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:
ClinicalTrials.gov Identifier:
NCT01557179
First Posted: March 19, 2012
Last Update Posted: March 19, 2012
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.
Collaborator:
Fidia Farmaceutici s.p.a.
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • percentage of improvement of vaginal dryness symptoms [ Time Frame: 30 days ]
    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 ]
    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

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes 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

Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT01557179     History of Changes
Other Study ID Numbers: LEES_Hyalofemme_1
Hyalofemme ( Registry Identifier: Hyalofemme )
First Submitted: March 14, 2012
First Posted: March 19, 2012
Last Update Posted: March 19, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents