Clinical trial NCT05559996: 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
Overall status: COMPLETED
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Keywords: vulvovaginal atrophy
hyaluronic acid
menopause
sexual dysfunction
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 42
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Vaginal dryness Burning Itching Dyspareunia Genital discomfort

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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

Primary outcomes:
measure: vaginal punch biopsy
timeFrame: One month
Secondary outcomes:
measure: Turkish validated form of the Female Sexual Function Index
timeFrame: One month
Other outcomes:
measure: Visual Analog Scale
timeFrame: One month
measure: Vaginal health index score
timeFrame: One month
Locations:
city: İstanbul
country: Turkey
facility: Maltepe University Faculty of Medicine
Study officials:
References: