- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05561972
The Ultrasonographic Assessment of Efficacy of Injectable Hyaluronic Acid for Genitourinary Syndrome of Menopause
Assessment of the Efficacy Of Multifractional Intercalated Hyaluronic Acid Injection for Genitourinary Syndrome of Menopause Using 3D High Frequency Vaginal Ultrasound
Genitourinary syndrome of menopause (GSM) is a definition including vaginal dryness, burning, vaginal pruritus, dyspareunia and urinary symptoms which can have a negative effect on women's sexuality and quality of life. The most common strategies to overcome GSM are non-hormonal (vaginal lubricants, topical moisturizers, energy-based devices etc.) and hormonal therapies. While vaginal lubricants are used during sexual intercourse and have temporary effects on vaginal epithelium, vaginal moisturizers are "bio-adhesive" products that can improve vaginal atrophy symptoms when used regularly. These products have not serious side effects but long-term effectiveness is not established. In the last decade, energy-based devices like laser and radiofrequency were used for treatment of GSM. Nevertheless, side effects and safety problems associated with these methods lead to uncertainty about the use of these methods in GSM therapy. Local and systemic estrogen therapies have been widely used for decades, but there is limited data on the persistence of the effect after estrogen use is stopped.
Hyaluronic acid (HA) is a glycosaminoglycan molecule that is an essential element of the extracellular matrix, with water-retention properties and regulatory effects on inflammation, scarring, and angiogenesis]. To date, many studies reported short-term improving effects of topical HA on GSM symptoms and have used subjective assessment of sexual symptoms and vaginal health scoring tools to investigate the effect of vaginal use of topical HA. However, since the injection of HA into the vagina will have a direct effect on the vaginal epithelium, it would be reasonable to expect a longer efficacy on GSM symptoms.
The methods used to diagnose GSM are subjective or provide unreliable objective evidence. Recently demonstrated as an objective diagnostic tool for GSM, 3D high frequency vaginal ultrasound (3D-HFVU) was used to separately measure anterior vaginal wall (ant-VWT) and posterior vaginal wall thickness (post-VWT) in contrast to 2D ultrasonography. To date, there are no studies to evaluate the effect of HA injection on the vaginal epithelium ultrasonographically.
The aim of the study was to investigate the effect of multifractional intercalated HA (MIC-HA) [Armonia®, Regenyal, Italy] injection on ant-VWT and post-VWT using 3D-HFVU, and also to assess the relationship between sexual functions and VWT increase in women with GSM after the injection. This is the first study to assess the effect of vaginal injection of MIC-HA on ant-VWT and post-VWT separately using 3D-HFVU.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
İstanbul, Turkey, 34844
- Maltepe University Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Postmenopausal women who had vaginal irritation, burning, vaginal pruritus, dryness and dyspareunia -
Exclusion Criteria:The presence of pelvic organ prolapse greater than stage I, vulvovaginitis, genital carcinoma, previous vaginal surgery, current use of vaginal moisturizers or lubricants, local or systemic estrogen treatment and antidepressant use, women those with known hypersensitivity to hyaluronic acid, betadine or lidocaine
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline anterior and posterior vaginal wall thickness at 4 weeks as detected by 3D high-frequency endovaginal ultrasound
Time Frame: The baseline and 4 weeks after intervention
|
The baseline and 4 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Turkish version of the Female Sexual Function Index
Time Frame: The baseline and 4 weeks after intervention
|
The baseline and 4 weeks after intervention
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vaginal health index
Time Frame: The baseline and 4 weeks after intervention
|
The baseline and 4 weeks after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/900/87
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Genitourinary Syndrome of Menopause
-
University of California, IrvineRecruitingGenitourinary Syndrome of MenopauseUnited States
-
Michigan Institution of Women's Health PCCompletedGenitourinary Syndrome of MenopauseUnited States
-
Stratpharma AGRecruitingGenitourinary Syndrome of MenopauseUnited States
-
EgymedicalpediaCompleted
-
Maltepe UniversityCompletedGenitourinary Syndrome of MenopauseTurkey
-
Centro de Atenção ao Assoalho PélvicoRecruitingGenitourinary Syndrome of MenopauseBrazil
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedGenitourinary Syndrome of MenopauseItaly
-
King's College Hospital NHS TrustAlexandra Hospital, Athens, GreeceCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalRecruitingGenitourinary Syndrome of MenopauseTurkey
-
Hacettepe UniversityCompletedGenitourinary Syndrome of MenopauseTurkey
Clinical Trials on injectable multifractional intercalated hyaluronic acid [Armonia®, Regenyal, Italy]
-
Maltepe UniversityCompletedGenitourinary Syndrome of MenopauseTurkey
-
Beirut Arab UniversityCompletedPeriodontitis Chronic Generalized SevereLebanon
-
Croma-Pharma GmbHFGK Clinical Research GmbHCompleted
-
AllerganCompletedAge-related Volume Deficit in the Mid-faceUnited States
-
I.R.A. Istituto Ricerche Applicate S.p.A.Opera CRO, a TIGERMED Group CompanyCompleted
-
Allergan MedicalCompletedNasolabial FoldsCanada
-
University of WasitActive, not recruiting