Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause

What this trial studies

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

Conditions in scope

• Menopause Syndrome
• Menopause Surgical
• Hot Flashes

Interventions

• Paroxetine (Drug) — 20 mg PO daily
• Placebo (Dietary Supplement) — 1 capsule starch

Who can join

Women only · Ages 18 Years to 80 Years · Accepts healthy volunteers.

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE2
• Start date: 2025-01-30
• Primary completion: 2025-07-31
• Last update posted: 2025-09-17
• First posted: 2025-01-08

Sponsor & contact

Lead sponsor: Universidad Nacional Autonoma de Honduras (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Menopause Rating Score (MRS) (Since intervention until 12 weeks)
  change in the Menopause Rating Scale (MRS), which measures 11 variables with a score of 0 to 4, with 0 being the absence of symptoms, scores range from 0 to 44.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.