NCT05782920

Brief Summary

The goal of this clinical trial is to:

  1. 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. 2.To evaluate the impact of vulvovaginal atrophy treatment on the sexual satisfaction of both partners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

February 19, 2023

Last Update Submit

March 23, 2023

Conditions

Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (12)

  • Vulvovaginal atrophy vaginal dryness severity scores

    scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms

    before treatment

  • Vulvovaginal atrophy vaginal dryness severity scores

    scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms

    after 1 month

  • Vulvovaginal atrophy vaginal dryness severity scores

    scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms

    after 2 months

  • Vulvovaginal atrophy vaginal dryness severity scores

    scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms

    3 months follow up

  • Vulvovaginal atrophy dyspareunia severity scores

    scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms

    before treatment

  • Vulvovaginal atrophy dyspareunia severity scores

    scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms

    after 1 month

  • Vulvovaginal atrophy dyspareunia severity scores

    scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms

    after 2 months

  • Vulvovaginal atrophy dyspareunia severity scores

    scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms

    3 months follow up

  • Vaginal health index total score

    scores range from 5-25 with lower scores signifying greater atrophy

    before treatment

  • Vaginal health index total score

    scores range from 5-25 with lower scores signifying greater atrophy

    after 1 month

  • Vaginal health index total score

    scores range from 5-25 with lower scores signifying greater atrophy

    after 2 months

  • Vaginal health index total score

    scores range from 5-25 with lower scores signifying greater atrophy

    3 months follow up

Study Arms (3)

PRP- treated Group A

ACTIVE COMPARATOR

15 female patients will receive 2 vaginal PRP injections one month apart.

Device: Platelet rich plasma

PRP-HA treated Group B

ACTIVE COMPARATOR

15 female patients will receive 2 vaginal PRP-non-cross-linked HA injections spaced a month apart.

Device: Platelet rich plasmaDevice: non cross-linked hyaluronic acid

Control Group C

ACTIVE COMPARATOR

15 female patients will receive topical non-cross-linked hyaluronic acid gel applied every three days for 2 months as a control group

Device: topical HA gel

Interventions

Platelet rich plasmaDEVICE

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

PRP- treated Group APRP-HA treated Group B
non cross-linked hyaluronic acidDEVICE

HA filling is a known modality for rejuvenation

PRP-HA treated Group B
topical HA gelDEVICE

the standard treatment of vaginal atrophy and dryness

Control Group C

Eligibility Criteria

AgeUp to 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales only will be included
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, 25211, Egypt

Location

Related Publications (2)

  • Hersant 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: 29738415BACKGROUND

  • Omar 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: 37417970DERIVED

Study Officials

  • Salma Omar, MD

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
As. Prof

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 24, 2023

Study Start

June 30, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)