Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Wom… (NCT06611514) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer
Italy95 participantsStarted 2024-12-01
Plain-language summary
The goal of this interventional study is to evaluate the effect of Intravaginal Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome (GSM) due to natural, surgical or treatment-induced menopause and the effect on the quality of life, including sexual function and mood well-being, in women with Breast Cancer. A sample size of 95 patients will be needed to show that the proportion of women showing symptom improvement is greater than 50%. Subjects will be followed up at four weeks and twelve weeks of treatment. One and three-month outcomes will be provided after the end of treatment. Comparison between menopausal women with previous breast cancer that have finished hormonal therapy or with ER negative breast cancer and women currently under endocrine therapy with AIs will be performed.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Establish subjective improvement in genitourinary symptomatology at intervals marked by the study
Timeframe: From enrollment to after 3 months after the end of treatment