Search / Trial NCT06611514

Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer

Launched by EUROPEAN INSTITUTE OF ONCOLOGY · Sep 20, 2024

Trial Information

Current as of December 22, 2024

Not yet recruiting

Keywords

Genitourinary Syndrome Prasterone Breast Cancer

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

Trial Officials

SILVIA MARTELLA

Principal Investigator

European Institue of Oncology

About European Institute Of Oncology

The European Institute of Oncology (IEO) is a leading research and treatment center based in Milan, Italy, dedicated to advancing cancer care through innovative clinical research and personalized medicine. Renowned for its commitment to multidisciplinary approaches, IEO integrates cutting-edge research with clinical practice to improve patient outcomes. The institute actively sponsors and conducts clinical trials across various cancer types, fostering collaboration between oncologists, researchers, and industry partners. With a focus on translating scientific discoveries into effective therapies, IEO plays a pivotal role in the global fight against cancer, contributing to the development of new treatment protocols and enhancing the understanding of oncological diseases.

Locations

Milan, , Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0