NCT05559996

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

Completed NA Last updated 29 September 2022

What this trial tests

NA trial testing Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy) in Genitourinary Syndrome of Menopause in 42 participants. Completed in 1 November 2021.

Timeline

1 April 2021

Primary endpoint
1 October 2021

1 November 2021

Quick facts

Lead sponsor	Maltepe University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	1 April 2021
Primary completion	1 October 2021
Estimated completion	1 November 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy)

Conditions studied

• Genitourinary Syndrome of Menopause — all drugs for Genitourinary Syndrome of Menopause →

Sponsor

Maltepe University

Who can join

Adults 45 to 65, female only, with Genitourinary Syndrome of Menopause. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.