Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause (NCT06763484) | Clinical Trial Compass
CompletedPhase 2
Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause
Honduras90 participantsStarted 2025-01-30
Plain-language summary
evaluate the efficacy of paroxetine in the management of vasomotor symptoms in patients with surgical menopause, in order to seek an alternative therapy to hormone therapy, which is associated with proinflammatory and procoagulant effects that increase the risk of thrombosis and is therefore contraindicated in people with diabetes mellitus, chronic arterial hypertension and patients with a history of thromboembolism
Who can participate
Age range
18 Years – 80 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:
* Patients with surgical menopause attending IHSS outpatient clinic.
* Patients with surgical menopause with presence of hot flashes and night sweats.
* Surgical menopausal patients with episodes of anxiety and palpitations.
* Patients with surgical menopause who receive treatment for 6 months with Paroxetine.
* Patients who after reading and explanation of the Informed Consent agree to participate voluntarily.
Exclusion Criteria:
* Patients medicated with psychotropic drugs, including all sedatives and hypnotics.
* Patients under treatment with Menopausal Hormone Therapy.
* Patients with impaired hepatic or renal function.
* Patients with unstable heart disease.
* Patients with a history of self-destructive behaviors.
* Patients with a history of clinical diagnosis or treatment for depression or any other psychiatric disorder (including substance abuse or alcohol disorders) and any other ongoing medical condition.
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.