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Management of Cancer Therapy Related Vulvovaginal Atrophy

NCT05782920 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-03-24

No results posted yet for this study

Summary

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

  • Genitourinary Syndrome of Menopause

Interventions

DEVICE

Platelet rich plasma

PRP can be considered a concentrate of autologous platelet-derived growth factors with known efficacy in tissue regeneration and wound healing.

DEVICE

non cross-linked hyaluronic acid

HA filling is a known modality for rejuvenation

DEVICE

topical HA gel

the standard treatment of vaginal atrophy and dryness

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Salma Omar, MD · Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05782920 on ClinicalTrials.gov