Status:
NOT_YET_RECRUITING
Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer
Lead Sponsor:
European Institute of Oncology
Conditions:
Women With Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT06611514
Start Date
December 1 2024
End Date
January 1 2027
Last Update
November 19 2024
Active Locations (1)
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1
European Institute of Oncology
Milan, Italy, 20141