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Completed

NCT Number: NCT05782920

Management of Cancer Therapy Related Vulvovaginal Atrophy

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.

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Key information

Conditions

Genitourinary Syndrome of Menopause

Age range

Up to 70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University

Alexandria, 25211, Egypt

About this study

  • 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)
  • 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.
  • 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.

  • 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).

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet rich plasma

Device

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

non cross-linked hyaluronic acid

Device

HA filling is a known modality for rejuvenation

topical HA gel

Device

the standard treatment of vaginal atrophy and dryness

Primary outcomes

  1. Vulvovaginal atrophy vaginal dryness severity scores

    Time frame: before treatment

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

  2. Vulvovaginal atrophy vaginal dryness severity scores

    Time frame: after 1 month

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

  3. Vulvovaginal atrophy vaginal dryness severity scores

    Time frame: after 2 months

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

  4. Vulvovaginal atrophy vaginal dryness severity scores

    Time frame: 3 months follow up

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

  5. Vulvovaginal atrophy dyspareunia severity scores

    Time frame: before treatment

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

  6. Vulvovaginal atrophy dyspareunia severity scores

    Time frame: after 1 month

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

  7. Vulvovaginal atrophy dyspareunia severity scores

    Time frame: after 2 months

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

  8. Vulvovaginal atrophy dyspareunia severity scores

    Time frame: 3 months follow up

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

  9. Vaginal health index total score

    Time frame: before treatment

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

  10. Vaginal health index total score

    Time frame: after 1 month

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

  11. Vaginal health index total score

    Time frame: after 2 months

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

  12. Vaginal health index total score

    Time frame: 3 months follow up

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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2023
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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