PRASTERONE for Genitourinary syndrome of menopause | Breast cancer

Inclusion criteria

• {"criterion_text":"- Histologically confirmed breast cancer, completely excised, TNM I-III"}
• {"criterion_text":"- ER negative or Positive Hormone Receptors Breast Cancer in therapy with aromatase inhibitor +/- LHRHa"}
• {"criterion_text":"- No evidence of distant metastasis (excluded TNM IV stage)"}
• {"criterion_text":"- Natural, surgically or treatment-induced menopause according to guidelines definition of menopause"}
• {"criterion_text":"- Self-identified moderate to severe symptoms of genitourinary syndrome that adversely affect quality of life and VHI (vaginal health index) score <15"}
• {"criterion_text":"- Clinical signs of vulvovaginal atrophy at the gynaecological examination"}
• {"criterion_text":"- Normal kidney and liver function"}
• {"criterion_text":"- Negative Papanicolau (Pap) Smear Cytology Test within 1 year prior to enrolment"}
• {"criterion_text":"- Women who have or want to have sexual intercourses"}
• {"criterion_text":"- Written Informed Consent signed and dated by patient"}

Exclusion criteria

• {"criterion_text":"- Vaginal or uterine bleeding of unknown origin"}
• {"criterion_text":"- Clinically significant metabolic or endocrine disease not controlled by medication"}
• {"criterion_text":"- Current diagnosis of any non-breast malignancy"}
• {"criterion_text":"- Metastatic disease"}
• {"criterion_text":"- Currently on chemiotherapy"}
• {"criterion_text":"- Currently on treatment with tamoxifen"}
• {"criterion_text":"- Mentally incompetent or evidence of active substance or alcohol abuse"}
• {"criterion_text":"- Endometrial hyperplasia"}
• {"criterion_text":"- Pregnancy or lactation"}
• {"criterion_text":"- Currently use of other vaginal therapy for the same purpose (if present, they have to be stopped 15 days before baseline visit"}
• {"criterion_text":"- Women with endometriosis, uncontrolled hypertension, vaginal infection and 1st degree heredity for breast cancer"}

Primary endpoints

• {"endpoint_text":"- Establish the subjective improvement of genitourinary symptoms in breast cancer women at intervals defined by the study","definition_or_measurement_approach":"Not specified"}

Secondary endpoints

• {"endpoint_text":"- To define the role of genito-urinary syndrome on quality of life, in particular on sexual function and mood wellbeing, in women with breast cancer before, during and after the treatment","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Establish an improvement in tissue trophism throught gynecological evaluation, use of validated scales (Vaginal Health Index) and determination of the maturation index on vaginal cytology","definition_or_measurement_approach":"Measured by gynecological evaluation, Vaginal Health Index (VHI) and maturation index on vaginal cytology"}
• {"endpoint_text":"- Measurement of serum estradiol at set intervals before, during and after treatment","definition_or_measurement_approach":"Serum estradiol measured at predefined time points"}

Italy

Earliest CTIS Part Ii Submission Date

06-06-2023

Latest Decision Or Authorization Date

14-05-2026

Processing Time Days

1073

Number Of Sites

1

Number Of Participants

95

Primary sponsor

Full Name

Istituto Europeo Di Oncologia S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Consorzio Per Valutazioni Biologiche E Farmacologiche","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"","full_name":"Theramex Italia","duties_or_roles":"supply prasterone","organisation_type":""}
• {"country":"","full_name":"Fondazione Umberto Veronesi","duties_or_roles":"","organisation_type":""}