Role of an hormonal vaginal therapy, the prasterone pessary, in the improvement of the vaginal/vulvar/urinary symptoms in menopausal women with previous breast cancer or currently under anti-hormonal treatment specific for breast cancer.

Phase 1

Conditions: Postmenopausal women with previous breast cancer or currently under anti-oesterogenic therapy (aromatase inhibitor +/- LHRH analogue) presenting vulvar, vaginal or urinary bothersome symptoms (genitourinary syndrome).
MedDRA version: 20.0Level: PTClassification code: 10006187Term: Breast cancer Class: 100000004864
MedDRA version: 23.1Level: PTClassification code: 10084249Term: Genitourinary syndrome of menopause Class: 100000004872
Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Therapeutic area: Diseases [C] - Neoplasms [C04]
Therapeutic area: Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Therapeutic area: Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]

Registration Number: CTIS2023-506211-18-00

Lead Sponsor: European Institute Of Oncology S.r.l.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 95

Inclusion Criteria

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

Exclusion Criteria

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