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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01557179

Enrollment

144

Registered

2012-03-19

Start date

2009-05-31

Completion date

2010-05-31

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEHyalofemme

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

DEVICEEstriol 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
percentage of improvement of vaginal dryness symptoms	30 days	percentage of improvement of vaginal dryness symptoms at the baseline and after treatment

Secondary

Measure	Time frame	Description
percentage of improvement of itching, dyspareunia and burning sensation	30 days	percentage of improvement of itching, dyspareunia and burning sensation at baseline and after treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026