NCT01557179
Completed
Phase 2
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
Lee's Pharmaceutical Limited0 sites144 target enrollmentStarted: May 2009Last updated:
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Lee's Pharmaceutical Limited
- Enrollment
- 144
- Primary Endpoint
- percentage of improvement of vaginal dryness symptoms
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- percentage of improvement of itching, dyspareunia and burning sensation(30 days)
Investigators
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