Genitourinary Syndrome of MenopauseNCT05571527
Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause
A study testing Platelet Rich Plasma treatment and Vaginal Hyaluronic Acid supplement in people with Genitourinary Syndrome of Menopause, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Genitourinary syndrome of menopause (GSM) is a collection of symptoms and signs caused by hypoestrogenic changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra, and bladder that occur in menopausal patients. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- Platelet Rich Plasma treatment and Vaginal Hyaluronic Acid supplement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Dec 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with menopause
- Patients with symptoms of genitourinary syndrome of menopause
Who cannot join
- Genitourinary bleeding or infection without a definitive diagnosis
- Coagulopathy
- Allergy to medication or therapy related to the treatment
- Chronic disease that might influence the outcome
- Using medication that might influence the outcome in 30 days
- Using hormone or steroid within 8 weeks
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- Personal history of vulvovaginal conditions such as lichen sclerosis, lichen planus, vulvovaginal condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, history of cervical or other gynecologic cancer, radical pelvic surgery, acute or recurrent urinary tract infection, genital infection, history of vaginal or pelvic radiation
- Chronic pelvic pain, current pelvic tension myalgia/muscle hypertonicity
- Pelvic organ prolapse greater than stage II
- Pelvic surgery within 6 months
- Known allergy to lidocaine or prilocaine
- Use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of therapy
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34307
Ozan Karadeniz, +905333663003, dr.ozankrdnz@gmail.com
About this study
Genitourinary syndrome of menopause (GSM) is a collection of symptoms and signs caused by hypoestrogenic changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra, and bladder that occur in menopausal patients.
Platelet-rich plasma is produced by collecting approximately 60-90 ml (4-6 tablespoons) of blood from the vein in patient's arm. The blood is spun using a centrifuge that separates the plasma and red blood cells.
The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet-rich plasma, etc. The observational cohort study will be used for the study design. Questionnaires, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used to evaluate the effectiveness and side effects.
Read the detailed description
PRIMARY OBJECTIVE:
To determine the safety and feasibility of using platelet-rich plasma (PRP) treatment in menopausal patients with genitourinary syndrome
SECONDARY OBJECTIVE:
To determine the preliminary efficacy in the treatment of vaginal atrophy, urinary symptoms, assessment of sexual function, quality of life symptoms
VSQ, Vaginal health index, Vaginal maturation index, and Day-to-Day Impact of Vaginal Aging score will be used for assessments.
OUTLINE:
Patients receive platelet-rich plasma via injection into the vaginal area after obtaining plasma into PRP tubes
After 3 sessions of PRP treatment, patients are followed up for 6 months.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- Platelet Rich Plasma treatment, Vaginal Hyaluronic Acid supplement
- Keywords
- genitourinary syndrome, menopause, platelet rich plasma, vaginal atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma treatmentBiological
Patients receive platelet-rich plasma via injection into the vaginal area.
Vaginal Hyaluronic Acid supplementDrug
Patients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Menopause patients having genitourinary syndrome (PRP) | Experimental | Preparation of PRP sample from the patient's own blood and then the volume immediately above the erythrocyte layer was collected. Calcium gluconate in conc. 1:9 will be used as an activator. After activation, in a period of less than 2 min, approximately 4 ml of the PRP will be injected into the vaginal wall. ( at 3,6 and 9 o clock)It will be repeated once a month for 3 times. Receives: Biological: Platelet Rich Plasma treatment |
| vaginal hyluronic acid supplement for GSM | Active comparator | Patients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months. Receives: Drug: Vaginal Hyaluronic Acid supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal health index score (VHIS)
evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration
Measured: [ Time Frame: 6 months after intervention ]
The Vulvovaginal Symptom Questionnaire (VSQ)
symptoms, emotions, life-impact, and sexual impact of vulvovaginal symptoms.
Measured: [ Time Frame: 6 months after intervention ]
Day-to-Day Impact of Vaginal Aging Questionnaire
Measure of the Impact of Vaginal Symptoms on Functioning and Well-being in Postmenopausal Women
Measured: [ Time Frame: 6 months after intervention ]
vaginal maturation index
objective, qualitative assessment of vaginal response to hormones as well as overall hormonal environment.
Measured: [ Time Frame: 6 months after intervention ]
vaginal health index
clinical tool that, by evaluating 5 parameters (vaginal elasticity, vaginal secretions, pH, epithelial mucous membrane, vaginal hydration)
Measured: [ Time Frame: 6 months after intervention ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Nov 2023
- Primary completion1 Mar 2024
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozan Karadeniz, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571527
- Sponsor's protocol ID
- KanuniSSEAH3
- Status last verified
- Mar 2024
- First submitted
- 4 Oct 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause
- ClinicalTrials.gov ID
- NCT05571527
- Acronym / sponsor ID
- KanuniSSEAH3
- Conditions
- Genitourinary Syndrome of Menopause
- Keywords
- genitourinary syndrome, menopause, platelet rich plasma, vaginal atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 7 Oct 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.
Genitourinary syndrome of menopause (GSM) is a collection of symptoms and signs caused by hypoestrogenic changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra, and bladder that occur in menopausal patients.
Platelet-rich plasma is produced by collecting approximately 60-90 ml (4-6 tablespoons) of blood from the vein in patient's arm. The blood is spun using a centrifuge that separates the plasma and red blood cells.
The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet-rich plasma, etc. The observational cohort study will be used for the study design. Questionnaires, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used to evaluate the effectiveness and side effects.
Detailed description
PRIMARY OBJECTIVE:
To determine the safety and feasibility of using platelet-rich plasma (PRP) treatment in menopausal patients with genitourinary syndrome
SECONDARY OBJECTIVE:
To determine the preliminary efficacy in the treatment of vaginal atrophy, urinary symptoms, assessment of sexual function, quality of life symptoms
VSQ, Vaginal health index, Vaginal maturation index, and Day-to-Day Impact of Vaginal Aging score will be used for assessments.
OUTLINE:
Patients receive platelet-rich plasma via injection into the vaginal area after obtaining plasma into PRP tubes
After 3 sessions of PRP treatment, patients are followed up for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menopause patients having genitourinary syndrome (PRP) | Experimental | Biological: Platelet Rich Plasma treatmentPreparation of PRP sample from the patient's own blood and then the volume immediately above the erythrocyte layer was collected. Calcium gluconate in conc. 1:9 will be used as an activator. After activation, in a period of less than 2 min, approximately 4 ml of the PRP will be injected into the vaginal wall. ( at 3,6 and 9 o clock)It will be repeated once a month for 3 times. |
| vaginal hyluronic acid supplement for GSM | Active comparator | Drug: Vaginal Hyaluronic Acid supplementPatients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with menopause
- Patients with symptoms of genitourinary syndrome of menopause
Key exclusion criteria (13 listed)
- Genitourinary bleeding or infection without a definitive diagnosis
- Coagulopathy
- Allergy to medication or therapy related to the treatment
- Chronic disease that might influence the outcome
- Using medication that might influence the outcome in 30 days
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 |
|---|---|---|
| Platelet Rich Plasma treatmentPatients receive platelet-rich plasma via injection into the vaginal area. | Biological | Menopause patients having genitourinary syndrome (PRP) |
| Vaginal Hyaluronic Acid supplementPatients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months. | Drug | vaginal hyluronic acid supplement for GSM |
Primary outcome
Vaginal health index score (VHIS)
Time frame: [ Time Frame: 6 months after intervention ]
evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration
The Vulvovaginal Symptom Questionnaire (VSQ)
Time frame: [ Time Frame: 6 months after intervention ]
symptoms, emotions, life-impact, and sexual impact of vulvovaginal symptoms.
Day-to-Day Impact of Vaginal Aging Questionnaire
Time frame: [ Time Frame: 6 months after intervention ]
Measure of the Impact of Vaginal Symptoms on Functioning and Well-being in Postmenopausal Women
vaginal maturation index
Time frame: [ Time Frame: 6 months after intervention ]
objective, qualitative assessment of vaginal response to hormones as well as overall hormonal environment.
vaginal health index
Time frame: [ Time Frame: 6 months after intervention ]
clinical tool that, by evaluating 5 parameters (vaginal elasticity, vaginal secretions, pH, epithelial mucous membrane, vaginal hydration)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma treatment and Vaginal Hyaluronic Acid supplement in people with Genitourinary Syndrome of Menopause, run by Kanuni Sultan Suleyman Training and Research Hospital 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 13 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozan Karadeniz, MD (+905333663003, dr.ozankrdnz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal health index score (VHIS) (time frame: [ Time Frame: 6 months after intervention ]). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2024.