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

European Institute Of Oncology S.r.l.0 个研究点目标入组 95 人开始时间: 2024年6月3日最近更新: 2024年8月21日

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

•Vaginal or uterine bleeding of unknown origin, Currently use of other vaginal therapy for the same purpose (if present, they have to be stopped 15 days before baseline visit, Women with endometriosis, uncontrolled hypertension, vaginal infection and 1st degree heredity for breast cancer, Clinically significant metabolic or endocrine disease not controlled by medication, 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

发起方

European Institute Of Oncology S.r.l.