Genitourinary Syndrome of MenopauseNCT05559996
Assessment of the Efficacy of Injectable Hyaluronic Acid for Genitourinary Syndrome of Menopause
A study testing Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy) in people with Genitourinary Syndrome of Menopause, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Vaginal dryness Burning Itching Dyspareunia Genital discomfort
- -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Maltepe University Faculty of Medicine
Istanbul, 34844
About this study
Official title: Assessment of the Efficacy of Multifractional Intercalated Hyaluronic Acid Injection for Genitourinary Syndrome of Menopause
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.
Read more
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.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy)
- Keywords
- vulvovaginal atrophy, hyaluronic acid, menopause, sexual dysfunction
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid injection | Experimental | Hyaluronic acid injection Receives: Device: Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One month
Secondary outcomes (1)
Turkish validated form of the Female Sexual Function Index
2 (minimum)-36 (maximum). Higher scores mean better outcome
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Apr 2021
- Primary completion1 Oct 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genitourinary Syndrome of MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559996
- Sponsor's protocol ID
- 2020/900/88
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leylek O, Peker BH, Bahat PY, Peker H, Demircivi E, Silav ZK. Short-term outcomes using of hyaluronic acid injection for genitourinary syndrome of menopause: a pilot study. J Sex Med. 2026 Sep 14;23(10):qdag293. doi: 10.1093/jsxmed/qdag293.
PubMed 42801790
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Multifractional Intercalated Hyaluronic Acid Injection for Genitourinary Syndrome of Menopause
- ClinicalTrials.gov ID
- NCT05559996
- Acronym / sponsor ID
- 2020/900/88
- Conditions
- Genitourinary Syndrome of Menopause
- Keywords
- vulvovaginal atrophy, hyaluronic acid, menopause, sexual dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid injection | Experimental | Device: Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy)Hyaluronic acid injection |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Vaginal dryness Burning Itching Dyspareunia Genital discomfort
- -
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy)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 | Device | Hyaluronic acid injection |
Primary outcome
vaginal punch biopsy
Time frame: One month
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
1 secondary outcome
Turkish validated form of the Female Sexual Function Index
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Derived from this study: PubMed 42801790Leylek O, Peker BH, Bahat PY, Peker H, Demircivi E, Silav ZK. Short-term outcomes using of hyaluronic acid injection for genitourinary syndrome of menopause: a pilot study. J Sex Med. 2026 Sep 14;23(10):qdag293. doi: 10.1093/jsxmed/qdag293.
Related trials for Genitourinary Syndrome of Menopause
Active, not recruiting
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
Cardiovascular Diseases
RecruitingObservational study
Predictors of Religious Orientation Attitudes in Menopausal Women
Menopause, Menopausal Syndrome
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Not yet recruitingPhase 4
Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
Menopausal Complaints, Vaginal Atrophy
Not yet recruiting
Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment
Genitourinary Syndrome of Menopause (GSM), Bacterial Vaginosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy) in people with Genitourinary Syndrome of Menopause, run by Maltepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaginal punch biopsy (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05559996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.