Comparing vaginal treatments for menopause symptoms
Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause
This study is testing whether a new vaginal treatment using hyaluronic acid works better than a treatment using your own blood to help women with menopause symptoms feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | Kanuni Sultan Suleyman Training and Research Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (İstanbul) |
| Trial ID | NCT05571527 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of vaginal hyaluronic acid treatment to autologous platelet-rich plasma (PRP) treatment for women experiencing genitourinary syndrome of menopause. It involves collecting blood to create PRP, which is then injected into the vaginal area. Patients will undergo three treatment sessions and will be monitored for six months to assess safety, feasibility, and preliminary efficacy using various questionnaires and examinations. The study aims to evaluate improvements in vaginal atrophy, urinary symptoms, sexual function, and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are menopausal women experiencing symptoms of genitourinary syndrome.
Not a fit: Patients with certain medical conditions, recent pelvic surgeries, or specific allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for women suffering from genitourinary syndrome of menopause.
How similar studies have performed: While there is ongoing interest in PRP treatments, this specific comparison of PRP and hyaluronic acid for this condition is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with menopause * Patients with symptoms of genitourinary syndrome of menopause Exclusion Criteria: * 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 * 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.
Where this trial is running
İstanbul
- Kanuni Sultan Suleyman Training and Research Hospital — İstanbul, Turkey (Recruiting)
Study contacts
- Study coordinator: Ozan Karadeniz, MD
- Email: dr.ozankrdnz@gmail.com
- Phone: +905333663003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.