Pilot Study of Individualized Treatment for Genitourinary Syndrome of Menopause in Women After Ca… (NCT07420647) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pilot Study of Individualized Treatment for Genitourinary Syndrome of Menopause in Women After Cancer Treatment
Slovenia65 participantsStarted 2024-10-15
Plain-language summary
This pilot study is designed to evaluate an individualized approach to the treatment of genitourinary syndrome of menopause (GSM) in women who have undergone oncological treatment. GSM is a common condition in postmenopausal women and may include symptoms such as vaginal dryness, irritation, pain during intercourse, and urinary discomfort. These symptoms can significantly affect quality of life and sexual function, particularly in women after cancer treatment.
The purpose of this study is to assess whether a personalized, non-hormonal treatment approach can effectively reduce GSM symptoms and improve overall quality of life and sexual function in this patient population. Participants will be assigned to an intervention group or a control group and will be followed prospectively over time.
The study will include women in menopause who have completed oncological treatment and experience symptoms of GSM. Clinical assessments, patient-reported outcomes, and quality-of-life questionnaires will be used to evaluate treatment effectiveness and safety.
The results of this pilot study may help inform future clinical practice and support the development of individualized, non-hormonal treatment strategies for women with GSM after cancer treatment.
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:
Female sex.
Postmenopausal women.
History of oncological treatment (e.g., gynecological or other malignancies).
Presence of genitourinary syndrome of menopause (GSM), including symptoms such as vaginal dryness, dyspareunia, burning, irritation, or urinary symptoms.
Completion of primary oncological treatment prior to enrollment.
Age ≥ 18 years.
Ability to understand the study procedures and provide written informed consent
Exclusion Criteria:
Current pregnancy or premenopausal status.
Active malignant disease requiring ongoing oncological treatment.
Acute genital or urinary tract infection at the time of enrollment.
Prior participation in another interventional clinical study that could influence study outcomes.
Known hypersensitivity or contraindication to study-related interventions.
Any medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation or outcome assessment.
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
Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms
Timeframe: Baseline
2
Change in Severity of Genitourinary Syndrome of Menopause (GSM) Symptoms
Timeframe: Throughout study completion: 3 times, every 4 weeks