CTIS2023-506211-18-00
进行中（未招募）
1 期
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2024年6月3日
适应症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: 100000004864MedDRA version: 23.1Level: PTClassification code: 10084249Term: Genitourinary syndrome of menopause Class: 100000004872Therapeutic 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]
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 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).
- 发起方
- European Institute Of Oncology S.r.l.
- 入组人数
- 95
- 状态
- 进行中（未招募）
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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
排除标准
- •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
结局指标
主要结局
未指定
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