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NCT Number: NCT06611514

Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer

The goal of this interventional study is to evaluate the effect of Intravaginal Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome (GSM) due to natural, surgical or treatment-induced menopause and the effect on the quality of life, including sexual function and mood well-being, in women with Breast Cancer. A sample size of 95 patients will be needed to show that the proportion of women showing symptom improvement is greater than 50%. Subjects will be followed up at four weeks and twelve weeks of treatment. One and three-month outcomes will be provided after the end of treatment. Comparison between menopausal women with previous breast cancer that have finished hormonal therapy or with ER negative breast cancer and women currently under endocrine therapy with AIs will be performed.

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Key information

Conditions

Women With Breast Cancer Breast Diseases Breast Neoplasms 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 3

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed breast cancer, completely excised
  • Natural or iatrogenic menopausal status
  • No evidence of distant metastasis
  • Self-identified moderate to severe symptoms of genitourinary syndrome
  • Normal kidney and liver function
  • Written Informed Consent signed and dated by patient
  • Negative Papanicolau (Pap) Smear Cytology Test within 1 year prior to enrollment

Exclusion criteria

  • Vaginal or uterine bleeding of unknown origin
  • Current diagnosis of any non-breast malignancy
  • Metastatic disease
  • Currently on chemiotherapy
  • Currently on treatment with tamoxifen
  • Mentally incompetent or evidence of active substance or alcohol abuse
  • Endometrial hyperplasia
  • Pregnancy or lactation
  • Currently use of other vaginal therapy for the same purpose (if present, they have to be stopped 15 days before baseline visit)
  • Clinically significant metabolic or endocrine disease not controlled by medication

Treatment and study plan

Prasterone (DHEA)

Drug

Prasterone 6.5 mg vaginal tablets

Primary outcomes

  1. Establish subjective improvement in genitourinary symptomatology at intervals marked by the study

    Time frame: From enrollment to after 3 months after the end of treatment

    To establish the improvement in vulvovaginal and urinary symptoms, by subjective evaluation at baseline, at 12 weeks and after 1 and 3 months after the end of the treatment. Establish tissue trophism improvement through gynecological evaluation, the use of validated scales (Vaginal Health Index), and determination of the maturation index on vaginal spatula, measure serum estradiol during and after treatment

  2. evaluation of vulvovaginal and urinary symptoms

    Time frame: 6 months

    evaluation of vaginal dryness, dyspareunia, pruritis, burning and dysuria with a 0 to 4 score (0: absence, 1: mild, 2: moderate, 3: severe, 4: very severe)

  3. improvement in vaginal signs

    Time frame: 6 months

    To establish the improvement in vaginal signs using the Vaginal Health Index Scale (VHI)

  4. evaluation fo maturation index

    Time frame: 6 months

    To assess the maturation index (as percentage of superficial, intermediate and parabasal cells) in the vaginal mucosa

  5. grade of satisfaction

    Time frame: 6 months

    To report the grade of satisfaction as measured by the Global Response Assessment at the end of the study

Study contacts

Contact information is provided by the study sponsor or research team.

SILVIA MARTELLA

CONTACT

[email protected]

0039 02 943742104

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

Effect of Intravaginal Prasterone on Genitourinary Syndrome in Women in Menopause With Previous Breast Cancer or Currently Under Treatment With Endocrine Therapy for Breast Cancer With Aromatase Inhibitor +/- LHRHa

Acronym: PROPOSE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2024
Registry last updated
Nov 19, 2024

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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