NCT05782920

Management of Cancer Therapy Related Vulvovaginal Atrophy

Completed NA Last updated 24 March 2023

What this trial tests

NA trial testing Platelet rich plasma in Genitourinary Syndrome of Menopause in 45 participants. Completed in 31 March 2021.

Timeline

30 June 2020

Primary endpoint
31 March 2021

31 March 2021

Quick facts

Lead sponsor	Alexandria University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	45
Start date	30 June 2020
Primary completion	31 March 2021
Estimated completion	31 March 2021
Sites	1 location across Egypt

Drugs / interventions tested

• Platelet rich plasma — full drug profile →
• non cross-linked hyaluronic acid
• topical HA gel

Conditions studied

• Genitourinary Syndrome of Menopause — all drugs for Genitourinary Syndrome of Menopause →

Sponsor

Alexandria University

Who can join

Under 70, female only, with Genitourinary Syndrome of Menopause. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparable Efficacy of Submucosal Platelet-Rich Plasma and Combined Platelet-Rich Plasma Noncrosslinked Hyaluronic Acid Injections in Vulvovaginal Atrophy: A Cancer Survivorship Issue.
   Omar SS, Elmulla KF, AboKhadr NA, Badawy AA, et al · · 2023 · cited 6× · PMID 37417970 · DOI 10.1089/jwh.2023.0144
2. Hydrogels as a new platform of therapeutic systems in oncological treatment - use as a protective barrier and drug carriers.
   Czerwiec K, Szczecińska W, Pikuła M. · · 2025 · PMID 41064525 · DOI 10.3389/fbioe.2025.1673253