Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05782920

Management of Cancer Therapy Related Vulvovaginal Atrophy

Genitourinary Syndrome of Menopause Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

1. The first group will receive two treatment of sub-mucosal PRP injection at the outer 3 cm of the vagina with one month interval in between. (17) 2. The second group will receive two treatment of PRP injection mixed with non-cross linked hyaluronic acid at the outer 3 cm of the vagina with one month interval in between. 9. 3-The third group will receive one applicator (5gm) three times per week of topical hyaluronic acid gel for vaginal application which will be prepared in the faculty of pharmacy for 2 months. Clinical assessment Patients will be assessed for symptoms and signs of vulvovaginal atrophy (VVA) at baseline, one month, two months, and, three months after the end of treatment. 1. Vulvovaginal atrophy (VVA) symptoms (dryness, dyspareunia) will be assessed on a subjective 10-point scale. Also, patient satisfaction with each type of treatment will be assessed with a questionnaire at the end of treatment and they will be asked if they wish to repeat the treatment to maintain effectiveness over time (yes or No). 2. For assessment of VVA signs on physical examination, vaginal health index including assessment of pH, overall elasticity, epithelial mucosa, fluid secretion type, and consistency and moisture will be used as an objective method of evaluation of therapy. 3. Assessment of sexual satisfaction of both male and female partners: Sexual satisfaction was measured using the Arabic version of the Index of Sexual Satisfaction (ISS) and female sexual function index (FSFI) questionnaire. ;

Study Design

Related Conditions & MeSH terms

  • Atrophy
  • Genitourinary Syndrome of Menopause
Clinical Trial Details
NCT number NCT05782920
Study type Interventional
Source Alexandria University
Contact
Status Completed
Phase N/A
Start date June 30, 2020
Completion date March 31, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05812924 - A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause Phase 2
Completed NCT04535323 - Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer Phase 1
Completed NCT03331328 - MonaLisa Touch Randomized Double-Blind Placebo Controlled Study N/A
Recruiting NCT04746456 - Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM
Withdrawn NCT04606550 - MonaLisa Laser Intervention for Post-Menopausal Breast Cancer Patients: A SHE CAN Study N/A
Completed NCT04705883 - Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors Phase 4
Recruiting NCT05953090 - VALOR: Vaginal Atrophy & Long-term Observation of Recovery N/A
Active, not recruiting NCT04619485 - Sexual and Vaginal Health in Breast Cancer Women Receiving Aromatase Inhibitors Before and After CO2 Laser Therapy N/A
Completed NCT04607798 - Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy N/A
Recruiting NCT06124820 - RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women With Recurrent Urinary Tract Infections N/A
Completed NCT05561972 - The Ultrasonographic Assessment of Efficacy of Injectable Hyaluronic Acid for Genitourinary Syndrome of Menopause N/A
Recruiting NCT05571527 - Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause N/A
Recruiting NCT04677491 - Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders Phase 4
Recruiting NCT05672901 - Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause N/A
Recruiting NCT03782480 - Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy Phase 3
Recruiting NCT06028009 - PRP Injections for Genitourinary Syndrome of Menopause N/A
Not yet recruiting NCT06007027 - Vaginal CO2 Laser Therapy for Genitourinary Syndrome in Breast Cancer Survivors N/A
Terminated NCT03857893 - New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy N/A
Completed NCT05464654 - Vaginal Biorevitalization With Polydeoxyribonucleotides for the Improvement of the Genitourinary Syndrome of Menopause N/A
Recruiting NCT04737616 - Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy N/A