Clinical trial · Interventional
Management of Cancer Therapy Related Vulvovaginal Atrophy
Comparison Between Platelet-rich Plasma (PRP) and Hyaluronic Acid (HA) in the Treatment of Cancer-therapy Related Vulvovaginal Atrophy and Its Impact on Sexual Satisfaction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to: 1. evaluate the efficacy of PRP injection and PRP injection mixed with non-cross-linked hyaluronic acid compared to the control group receiving standard therapy with topical non-cross-linked hyaluronic acid gel in the treatment of cancer therapy-induced or worsened vulvovaginal atrophy. 2. To evaluate the impact of vulvovaginal atrophy treatment on the sexual satisfaction of both partners. Patients will be divided randomly into 3 groups: Group 1: 15 female patients will receive vaginal PRP injections. Group 2: 15 female patients will receive vaginal PRP injections combined with non-cross-linked hyaluronic acid. Group 3: 15 female patients will receive topical non-cross-linked hyaluronic acid gel as a control group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genitourinary Syndrome of Menopause | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| non cross-linked hyaluronic acid | Device | — | UNRESOLVED |
| Platelet rich plasma | Device | — | UNRESOLVED |
| topical HA gel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- PRP- treated Group A
- description
- 15 female patients will receive 2 vaginal PRP injections one month apart.
- interventionNames
- Device: Platelet rich plasma
- type
- ACTIVE_COMPARATOR
- label
- PRP-HA treated Group B
- description
- 15 female patients will receive 2 vaginal PRP-non-cross-linked HA injections spaced a month apart.
- interventionNames
- Device: Platelet rich plasma
- Device: non cross-linked hyaluronic acid
- type
- ACTIVE_COMPARATOR
- label
- Control Group C
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients have symptoms of VVA (vaginal dryness, burning, itching or dyspareunia) * Patients with vaginal health index \< 15. * All patients have already finished cancer therapy or are on anti-estrogen treatment. * Married sexually active * Patients who are not receiving any VVA treatment for at least 30 days before starting therapy. Exclusion Criteria: * Active or recent history of vulvovaginal inflammation or infection * History of vulvar or vaginal cancer. * Suspicious lesion in the vulvovaginal area on the gynecological examination
References
Publications (2)
- BACKGROUNDHersant B, SidAhmed-Mezi M, Belkacemi Y, Darmon F, Bastuji-Garin S, Werkoff G, Bosc R, Niddam J, Hermeziu O, La Padula S, Meningaud JP. Efficacy of injecting platelet concentrate combined with hyaluronic acid for the treatment of vulvovaginal atrophy in postmenopausal women with history of breast cancer: a phase 2 pilot study. Menopause. 2018 Oct;25(10):1124-1130. doi: 10.1097/GME.0000000000001122. PMID 29738415
- DERIVEDOmar SS, Elmulla KF, AboKhadr NA, Badawy AA, Ramadan EN, Hassouna AM, Heikal LA, Arafat WO. Comparable Efficacy of Submucosal Platelet-Rich Plasma and Combined Platelet-Rich Plasma Noncrosslinked Hyaluronic Acid Injections in Vulvovaginal Atrophy: A Cancer Survivorship Issue. J Womens Health (Larchmt). 2023 Sep;32(9):1006-1020. doi: 10.1089/jwh.2023.0144. Epub 2023 Jul 7. PMID 37417970