An interventional study of Autologous Platelet-Rich Plasma (PRP) and 0.9% sodium chloride (normal saline) in Genitourinary Syndrome of Menopause (GSM), sponsored by National and Kapodistrian University of Athens. Completed at 1 site in Greece. Open to female participants. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by National and Kapodistrian University of Athens · Not applicable, Interventional, and Treatment
This study evaluates whether subepithelial injection of autologous platelet-rich plasma (PRP) into the vaginal wall produces histological changes consistent with tissue regeneration in postmenopausal women with genitourinary syndrome of menopause (GSM). Women with GSM and concomitant pelvic organ prolapse who were scheduled for reconstructive prolapse surgery received two treatment sessions four weeks apart. Within each participant, three predefined vaginal regions received PRP injection, normal saline injection or no intervention. At the time of prolapse surgery, four weeks after the second session, biopsies were obtained from all three regions and assessed by a pathologist blinded to treatment allocation. Epithelial thickness, epithelial glycogen content, epithelial proliferative activity, vascular density, subepithelial papillae and collagen architecture were compared among the three sites.
National and Kapodistrian University of Athens is the lead sponsor of 176 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: women with at least one genitourinary symptom and clinical evidence of vaginal atrophy, defined as a Vaginal Health Index Score (VHIS) \<15, were consecutively recruited from the Urogynecology Unit of Alexandra General Hospital. Eligible women had concomitant pelvic organ prolapse of stage II or greater according to the Pelvic Organ Prolapse Quantification (POP-Q) system and were scheduled for reconstructive prolapse surgery. Postmenopausal status was defined as at least 12 months of amenorrhea. All participants were required to provide written and comply with the study procedures and follow-up schedule.
Exclusion Criteria: systemic or local hormonal therapy within the preceding three months; vulvovaginal dermatoses; lower genital tract neoplasia or gynecological ; previous pelvic irradiation; active genital or urinary tract infection; chronic pelvic pain; pelvic surgery within the preceding six months; known to study-related medications or materials; hematological abnormalities; ; uncontrolled systemic disease; or any other condition judged by the investigators to compromise participation or outcome assessment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant received two treatment sessions four weeks apart. In each session, one predefined vaginal region received subepithelial injection of autologous platelet-rich plasma (4 mL; 40 injections of 0.1 mL), a second region received subepithelial injection of 0.9% normal saline using the identical technique and volume, and the third region received no injection. Regions were the right and left halves of the anterior vaginal wall and the posterior vaginal wall, assigned by predetermined non-randomized cyclic rotation. Biopsies from all three regions were obtained at prolapse surgery, four weeks after the second session.
Biological: Autologous Platelet-Rich Plasma (PRP) · Other: 0.9% sodium chloride (normal saline)
Leukocyte-poor autologous PRP prepared immediately before each session from 40 mL of peripheral venous blood using the OMNIPLEX Gyno kit (two-step centrifugation: 3200 rpm for 4 min, then 4000 rpm for 20 min), without exogenous activation. Administered subepithelially with a 30-gauge needle as 40 injections of 0.1 mL (4 mL total) into the assigned vaginal region, in two sessions four weeks apart.
Subepithelial injection of 4 mL of 0.9% normal saline (40 injections of 0.1 mL) into the assigned vaginal region, using the same technique and schedule as PRP; injection control.
Epithelial thickness
Mean vaginal epithelial thickness (μm) measured by digital morphometry on hematoxylin and eosin-stained sections (mean of five non-overlapping fields per biopsy, ×10), compared between PRP-treated, saline-treated and no intervention sites within participants.
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Vascular density of the lamina propria
Number of factor VIII-positive vessels per mm² of lamina propria on immunohistochemistry (mean of five non-overlapping fields per biopsy, ×10), compared between PRP-treated, saline-treated and no intervention sites within participants.
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Epithelial glycogen area fraction
Glycogen area fraction (%) of the epithelium on periodic acid-Schiff-stained sections (mean of five fields, ×10), compared between PRP-treated, saline-treated and no intervention sites within participants.
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Epithelial proliferative activity
Density of Ki-67-positive basal and parabasal epithelial cells (cells/mm² of epithelium), compared between PRP-treated, saline-treated and no intervention sites within participants.
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Subepithelial papillae
Number of subepithelial papillae per microscopic field at ×10 (mean of five fields), compared between PRP-treated, saline-treated and no intervention sites within participants.
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Collagen Architecture Score
Study-specific semiquantitative score on Masson's trichrome-stained sections (×20): trabecular organization, bundle thickness/definition and stromal connectivity, each graded 0-2 (field score 0-6; higher scores indicate more organized collagen); biopsy score is the mean of five fields. Compared between PRP-treated, saline-treated and no intervention sites within participants.
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Histological outcomes by baseline and clinical characteristics (exploratory)
Hypothesis-generating subgroup analyses of the primary outcomes (PRP vs saline vs no intervention) by baseline atrophy severity ; vaginal maturation value; vaginal pH; age; BMI and sexual activity.
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Histological outcomes by anatomical site (exploratory)
Primary and secondary histological outcomes compared between anterior and posterior vaginal wall biopsy sites, irrespective of treatment allocation.
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Platelet rich plasma
National and Kapodistrian University of Athens →