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

NCT06611514 | Not Yet Recruiting Phase 3

• 1 other identifier: UID 2966
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Women With Breast Cancer

Keywords

genitourinary syndrome; prasterone; breast cancer

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

intravaginal Prasterone

EXPERIMENTAL

Drug: Prasterone (DHEA)

Interventions

Prasterone (DHEA) DRUG

Prasterone 6.5 mg vaginal tablets

intravaginal Prasterone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• SILVIA MARTELLA

  European Institue of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SILVIA MARTELLA

CONTACT

0039 02 943742104; silvia.martella@ieo.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 25, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 19, 2024

Record last verified: 2024-09

Locations

IT (1)