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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Women With Breast Cancer
• Intervention / Treatment: Drug: Prasterone (DHEA)

• Study Type: Interventional
• Enrollment (Estimated): 95
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: SILVIA MARTELLA; Phone Number: 0039 02 943742104; Email: silvia.martella@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • European Institute of Oncology
    • Contact: SILVIA MARTELLA; Phone Number: 0039 02 943742104; Email: silvia.martella@ieo.it
    • Principal Investigator: SILVIA MARTELLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intravaginal Prasterone	Drug: Prasterone (DHEA); Prasterone 6.5 mg vaginal tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish subjective improvement in genitourinary symptomatology at intervals marked by the study	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	From enrollment to after 3 months after the end of treatment
evaluation of vulvovaginal and urinary symptoms	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)	6 months
improvement in vaginal signs	To establish the improvement in vaginal signs using the Vaginal Health Index Scale (VHI)	6 months
evaluation fo maturation index	To assess the maturation index (as percentage of superficial, intermediate and parabasal cells) in the vaginal mucosa	6 months
grade of satisfaction	To report the grade of satisfaction as measured by the Global Response Assessment at the end of the study	6 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: SILVIA MARTELLA, European Institue of Oncology

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; genitourinary syndrome; prasterone
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Immunologic Factors; Physiological Effects of Drugs; Adjuvants, Immunologic; Dehydroepiandrosterone
• Other Study ID Numbers: UID 2966

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No