Genitourinary Syndrome of Menopause (GSM)NCT07905820
Vaginal Platelet-Rich Plasma and Vaginal Histology in Genitourinary Syndrome of Menopause
A study testing Autologous Platelet-Rich Plasma (PRP) and 0.9% sodium chloride (normal saline) in people with Genitourinary Syndrome of Menopause (GSM), run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause (GSM)
- What is being tested?
- Autologous Platelet-Rich Plasma (PRP) and 0.9% sodium chloride (normal saline)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2023to 31 Jul 2026
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: Postmenopausal 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 informed consent 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 malignancy; previous pelvic irradiation; active genital or urinary tract infection; chronic pelvic pain; pelvic surgery within the preceding six months; known hypersensitivity to study-related medications or materials; clinically significant hematological abnormalities; immunosuppression; uncontrolled systemic disease; or any other condition judged by the investigators to compromise participation or outcome assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histological Effects of Subepithelial Vaginal Platelet-Rich Plasma for Women With Genitourinary Syndrome of Menopause and Pelvic Organ Prolapse: A Prospective Split-Vagina Controlled Study
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.
- Being tested
- Autologous Platelet-Rich Plasma (PRP), 0.9% sodium chloride (normal saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-Rich Plasma (PRP)Biological
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.
0.9% sodium chloride (normal saline)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Split-vagina: PRP vs normal saline vs no intervention | Experimental | 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. Receives: Biological: Autologous Platelet-Rich Plasma (PRP); Other: 0.9% sodium chloride (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Apr 2023
- Primary completion30 Apr 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of Menopause (GSM)Studies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Model description
- Within-participant (split-vagina) controlled design. Each participant received PRP injection, 0.9% normal saline injection and no intervention in three predefined vaginal regions (right half of the anterior vaginal wall, left half of the anterior vaginal wall and posterior vaginal wall). Interventions were assigned to regions according to a predetermined, non-randomized cyclic rotation across consecutive participants, and each region retained the same assignment at both treatment sessions.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Themos Grigoriadis, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905820
- Sponsor's protocol ID
- 17-6-22/3428
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Effects of Subepithelial Vaginal Platelet-Rich Plasma for Women With Genitourinary Syndrome of Menopause and Pelvic Organ Prolapse: A Prospective Split-Vagina Controlled Study
- ClinicalTrials.gov ID
- NCT07905820
- Acronym / sponsor ID
- 17-6-22/3428
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 29 Oct 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-participant (split-vagina) controlled design. Each participant received PRP injection, 0.9% normal saline injection and no intervention in three predefined vaginal regions (right half of the anterior vaginal wall, left half of the anterior vaginal wall and posterior vaginal wall). Interventions were assigned to regions according to a predetermined, non-randomized cyclic rotation across consecutive participants, and each region retained the same assignment at both treatment sessions.
| Arm | Type | Receives |
|---|---|---|
| Split-vagina: PRP vs normal saline vs no intervention | Experimental | Biological: Autologous Platelet-Rich Plasma (PRP), Other: 0.9% sodium chloride (normal saline)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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Autologous Platelet-Rich Plasma (PRP)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. | Biological | Split-vagina: PRP vs normal saline vs no intervention |
| 0.9% sodium chloride (normal saline)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. | Other | Split-vagina: PRP vs normal saline vs no intervention |
Primary outcome
Epithelial thickness
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
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.
Vascular density of the lamina propria
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
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.
4 secondary outcomes
Epithelial glycogen area fraction
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Epithelial proliferative activity
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Subepithelial papillae
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
Collagen Architecture Score
Time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery
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 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Autologous Platelet-Rich Plasma (PRP) and 0.9% sodium chloride (normal saline) in people with Genitourinary Syndrome of Menopause (GSM), run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. 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 Greece. 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?
Epithelial thickness (time frame: Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery). The study lists 2 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 29 Oct 2026.