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NCT Number: NCT05812924

A Novel Therapy for Breast Cancer Survivors With Genitourinary Syndrome of Menopause

The purpose of this study is to determine whether platelet rich plasma (PRP) injections to the vulva and vagina will improve symptoms of genitourinary syndrome of menopause (GSM) in breast cancer patients.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Genitourinary Syndrome of Menopause Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients who are age 18 years and older
  • Patients must have a history of biopsy-proven Ductal carcinoma in situ (DCIS) or Stage I-III breast cancer and must be currently undergoing treatment or have completed primary treatment.
  • Patients must be found to have a vaginal health index (VHI) score of <15.
  • Patients may be currently using endocrine therapy (ovarian function suppression, tamoxifen, or aromatase inhibitors). Patients not currently using endocrine therapy will also be eligible for participation since patients more than 5 or 10 years from diagnosis (and therefore having completed adjuvant endocrine therapy) may be enrolled.
  • Some patients with triple negative breast cancer who receive chemotherapy also experience GSM related to ovarian function decline outside of the setting of ovarian suppression, and therefore patients with either ER+ or ER- breast cancer will be allowed to participate.
  • Patients must provide written informed consent for participation in this study.
  • Patients are allowed to have used non-hormonal moisturizers but if they have previously used hormonal moisturizers, they will be asked to stop the use for one month prior to the first planned treatment, termed the "washout period", if needed.

Exclusion criteria

  • Patients with any systemic or topical hormone replacement therapy within 3 months prior to enrollment, known genital infection, coagulation disorders, or on anticoagulant therapy or turmeric-containing supplements within the prior 2 weeks will be excluded.
  • Women who are pregnant or who plan to become pregnant within the following six months will be excluded since the impact of recent PRP injections to the vulva and the impact on obstetric injury during vaginal delivery has not been studied.

Treatment and study plan

Platelet-Rich Plasma (PRP)

Biological

0.1-0.2 mL injections of platelet-rich plasma (PRP) will be injected to the vulvovaginal area. The injections will be placed every 5mm and at an angle of 60° into the mucosa and lamina propria of the posterior wall of the vagina.

Primary outcomes

  1. Change in GSM symptoms as measured by vulvovaginal symptom questionnaire (VSQ).

    Time frame: Baseline, up to 31 weeks

    The VSQ is a 21-question survey that specifically asks about GSM symptoms and their impact on quality of life and sexual function. Vaginal and vulvar symptoms will be self-reported using validated VSQ modified to 4-point Likert scores. VSQ consists of a series of questions, each of which is rated as 0 (never), 1(rarely), 2(sometimes), 3 (frequently). Lower scores indicate better health. Each question is analyzed separately; there is no overall score reported.

Secondary outcomes

  1. Change in Vaginal health index (VHI) Score

    Time frame: Baseline, up to 31 weeks

    VHI assesses post menopausal symptoms such as dryness, burning, and irritation. Each component is scored on a scale of 1 (worst) to 5 (best). Lower scores indicate more severe atrophy.

  2. Change in validated female sexual function index (FSFI)

    Time frame: Baseline, up to 31 weeks

    Change in validated female sexual function index (FSFI) is determined by the participant response to the female sexual function index (FSFI) questionnaire. The FSFI is a questionnaire competed by the participant and is designed to measure sexual functioning by assessing six areas of sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Scores range from 2 to 36. Higher scores indicate better sexual function.

  3. Change in sexual-related distress (FSDS-R).

    Time frame: Baseline, up to 31 weeks

    Change in validated female sexual distress is determined by participant response to the female sexual distress survey-revised (FSDS-R). The FSDS-R is a self reported questionnaire that asks participants to rate distress related to low sexual desire. Responses to the items on the Likert-type scale consist of never (0), rarely (1), sometimes (2), often (3), or always (4). The lowest score that can be obtained from the FSDS-R is "0" and the highest score is "52". Higher scores indicate higher levels of sexual distress.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2023
Registry last updated
May 13, 2026

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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