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

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called Intravaginal Prasterone on women who have experienced menopause and have had breast cancer. Specifically, it's looking at how this treatment can help improve symptoms related to the genitourinary syndrome of menopause (GSM), which can include issues like dryness, discomfort, and problems with sexual function. The trial aims to see if more than half of the women taking this treatment notice an improvement in their symptoms. To participate, women must be between the ages of 65 and 74, have had their breast cancer completely treated, and currently experience moderate to severe GSM symptoms.

Participants in the study will receive the treatment for a total of 12 weeks and will be checked in with researchers at four weeks and again at twelve weeks to see how they are doing. It's important for potential participants to know that they should not be on certain medications or treatments, such as chemotherapy or other vaginal therapies, while in the study. This trial is not yet recruiting, so those interested will need to wait for more information on when they can enroll.

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