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

Lee's Pharmaceutical

Status and phase: Completed; Phase 2

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

Treatments: Device: Estriol cream (Ovestin); Device: Hyalofemme

Study type: Interventional

Funder types: Industry

Identifiers

NCT01557179

LEES_Hyalofemme_1

Hyalofemme (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: Female

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Hyaluronic acid vaginal gel (Hyalofemme)

Experimental group

Description:

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

Treatment:

Device: Hyalofemme

Estriol cream (Ovestin)

Active Comparator group

Description:

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

Treatment:

Device: Estriol cream (Ovestin)