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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.
EU CTIS ID: 2023-506211-18-00
What this study is testing
Establish the subjective improvement of genitourinary symptoms in breast cancer women at intervals defined by the study
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.