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

NCT01557179 | Completed Phase 2

• 2 other identifiers: LEES_Hyalofemme_1Hyalofemme
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

The Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal Dryness

Outcome Measures

Primary Outcomes (1)

• percentage of improvement of vaginal dryness symptoms

  percentage of improvement of vaginal dryness symptoms at the baseline and after treatment

  30 days

Secondary Outcomes (1)

• percentage of improvement of itching, dyspareunia and burning sensation

  30 days

Study Arms (2)

Hyaluronic acid vaginal gel (Hyalofemme)

EXPERIMENTAL

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

Estriol cream (Ovestin)

ACTIVE COMPARATOR

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)

Interventions

Hyalofemme DEVICE

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

Hyaluronic acid vaginal gel (Hyalofemme)

Estriol cream (Ovestin) DEVICE

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

Estriol cream (Ovestin)

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead
• Fidia Farmaceutici s.p.a.: collaborator

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 19, 2012
• Study Start: May 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: May 1, 2010
• Last Updated: March 19, 2012

Record last verified: 2012-03