NCT06763484

Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause

Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause. Randomized Double-blind Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Universidad Nacional Autonoma de Honduras · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Detailed description

Vasomotor symptoms that occur in the peri-menopausal and postmenopausal period are experienced by 80% of women and can greatly affect the quality of life by temporarily interrupting daily activities. These symptoms are experienced early in our study population who are induced to early menopause by undergoing surgical procedures such as total abdominal hysterectomy plus bilateral salpingo-oophorectomy. Due to the controversy that exists about the use of hormone replacement therapy, in recent years different alternative therapies have been proposed for the management of these symptoms, mainly for those patients who have contraindications for hormone therapy. For this reason, the use of non-hormonal therapy has been investigated. Since there are women who have contraindications to conventional therapy such as patients with cardiovascular and thrombosis risks, there is a need to search for new alternative therapies such as selective serotonin reuptake inhibitors, specifically paroxetine, so with our study we seek to evaluate how effective paroxetine is in reducing vasomotor symptoms and thus provide an alternative to this type of patients.

Conditions

• Menopause Syndrome
• Menopause Surgical
• Hot Flashes

Interventions

Type	Name	Description
DRUG	Paroxetine	20 mg PO daily
DIETARY_SUPPLEMENT	Placebo	1 capsule starch

Timeline

• Start date: 2025-01-30
• Primary completion: 2025-07-31
• Completion: 2025-09-01
• First posted: 2025-01-08
• Last updated: 2025-09-17

Locations

1 site across 1 country: Honduras