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Assessment of the Efficacy of Injectable Hyaluronic Acid for Genitourinary Syndrome of Menopause

Primary Purpose

Genitourinary Syndrome of Menopause

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy)
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genitourinary Syndrome of Menopause focused on measuring vulvovaginal atrophy, hyaluronic acid, menopause, sexual dysfunction

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Vaginal dryness Burning Itching Dyspareunia Genital discomfort

-

Exclusion Criteria:

Presence of pelvic organ prolapse Vaginal infections History of genital carcinoma Vulvovaginal dystrophic diseases Previous vaginal surgery Current use of vaginal moisturizer or lubricant, and use of estrogen History of allergies to hyaluronic acid, betadine or lidocaine

Sites / Locations

  • Maltepe University Faculty of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyaluronic acid injection

Arm Description

Hyaluronic acid injection

Outcomes

Primary Outcome Measures

vaginal punch biopsy
4-6 millimeter depth vaginal punch biopsy was taken from the posterior wall of vagina, between 6 and 7 o'clock, 1 cm inside from the hymen by a true-cut punch biopsy device (Robbins® True-Cut Disposable Biopsy Punch 5mm, Robbins Instruments, 2003 Edwards St. Houston, TX 77007). Histologically, epithelial thickness, vascularity and dermal papilla prominence were evaluated. Periodic acid schiff (PAS) staining was used to evaluate glycogenization in epithelial cells, while Masson's trichrome histochemical staining was used to evaluate the distribution and density of collagen (neo-collagenization) in the lamina propria

Secondary Outcome Measures

Turkish validated form of the Female Sexual Function Index
2 (minimum)-36 (maximum). Higher scores mean better outcome

Full Information

First Posted
September 22, 2022
Last Updated
September 28, 2022
Sponsor
Maltepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05559996
Brief Title
Assessment of the Efficacy of Injectable Hyaluronic Acid for Genitourinary Syndrome of Menopause
Official Title
Assessment of the Efficacy of Multifractional Intercalated Hyaluronic Acid Injection for Genitourinary Syndrome of Menopause
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maltepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The vaginal wall consists of epithelium, lamina propria, muscularis and adventitia (1). The decrease in postmenopausal estrogen levels causes thinning of the vaginal wall thickness and the development of genitourinary menopause syndrome (GSM), which is characterized by vaginal dryness, burning, pruritus, urinary complaints and sexual discomfort (2). In the treatment of GSM symptomatology, there are many different non-hormonal treatment options such as vaginal topical agents and energy-based devices, as well as estrogen-based hormonal therapies (3). The main problem with non-hormonal treatments is the short-term resolution of vaginal atrophy and the lack of long-term results, while contraindications such as breast cancer history and unwillingness of the women to use hormones are problematic for estrogen-based treatments. Considering all these issues, there is a search for new therapeutic agents with long and high efficiency and safety profile in the treatment of GSM. Hyaluronic acid (HA) which is one of the main components of the extracellular matrix and has water-binding property that provides moisturizing and lubricating effect (4). Besides, it is also reported as the key to the process of tissue regeneration through inflammation, cellular migration and angiogenesis (5). For these reasons, it seems to be a promising treatment of GSM symptomatology. HA has many routes of administration, such as vaginal gels, ovules, and suppositories, and studies have shown that locally applied HA preparations have a short-term therapeutic effect on GSM symptoms (6). However, there is no consensus regarding HA efficacy due to heterogeneity of studies. Since it is an endogenous molecule, it can be thought that it will be more effective if it is injected directly into the epithelium rather than locally applied. The injectable form of multifractional intercalated cross-linked HA (MIC-HA) (Armonia®, Regenyal, Italy) is designed for the reinforcement of the extracellular matrix in the female genital area. We intend to investigate and objectively evaluate the efficacy of MIC-HA injection on GSM symptoms and sexual functions in postmenopausal women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genitourinary Syndrome of Menopause
Keywords
vulvovaginal atrophy, hyaluronic acid, menopause, sexual dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid injection
Arm Type
Experimental
Arm Description
Hyaluronic acid injection
Intervention Type
Device
Intervention Name(s)
Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy)
Intervention Description
2 mL of Armonia was injected into the vaginal wall with a standardized injection technique called Cannulated Intravaginal Injection Technique®. In this technique, Armonia® was injected as drops at 40 different points on the entire vaginal wall using 8 different entry points
Primary Outcome Measure Information:
Title
vaginal punch biopsy
Description
4-6 millimeter depth vaginal punch biopsy was taken from the posterior wall of vagina, between 6 and 7 o'clock, 1 cm inside from the hymen by a true-cut punch biopsy device (Robbins® True-Cut Disposable Biopsy Punch 5mm, Robbins Instruments, 2003 Edwards St. Houston, TX 77007). Histologically, epithelial thickness, vascularity and dermal papilla prominence were evaluated. Periodic acid schiff (PAS) staining was used to evaluate glycogenization in epithelial cells, while Masson's trichrome histochemical staining was used to evaluate the distribution and density of collagen (neo-collagenization) in the lamina propria
Time Frame
One month
Secondary Outcome Measure Information:
Title
Turkish validated form of the Female Sexual Function Index
Description
2 (minimum)-36 (maximum). Higher scores mean better outcome
Time Frame
One month
Other Pre-specified Outcome Measures:
Title
Visual Analog Scale
Description
0 (minimum)-10 (maximum). Higher scores mean worse outcome
Time Frame
One month
Title
Vaginal health index score
Description
5 (minimum)-25 (maximum). Higher scores mean better outcome
Time Frame
One month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Vaginal dryness Burning Itching Dyspareunia Genital discomfort - Exclusion Criteria: Presence of pelvic organ prolapse Vaginal infections History of genital carcinoma Vulvovaginal dystrophic diseases Previous vaginal surgery Current use of vaginal moisturizer or lubricant, and use of estrogen History of allergies to hyaluronic acid, betadine or lidocaine
Facility Information:
Facility Name
Maltepe University Faculty of Medicine
City
İstanbul
ZIP/Postal Code
34844
Country
Turkey

12. IPD Sharing Statement

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Assessment of the Efficacy of Injectable Hyaluronic Acid for Genitourinary Syndrome of Menopause

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