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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Hyalofemme
* Device: Estriol cream (Ovestin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic acid vaginal gel (Hyalofemme)<br>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<br>* 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<br>|
| Active Comparator: Estriol cream (Ovestin)<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of improvement of vaginal dryness symptoms | percentage of improvement of vaginal dryness symptoms at the baseline and after treatment | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of improvement of itching, dyspareunia and burning sensation | percentage of improvement of itching, dyspareunia and burning sensation at baseline and after treatment | 30 days |