Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause

Phase 2

Recruiting

• Conditions: Hot Flashes; Menopause Syndrome; Menopause Surgical
• Interventions: Drug: Paroxetine; Dietary Supplement: Placebo

• Registration Number: NCT06763484
• Lead Sponsor: Universidad Nacional Autonoma de Honduras

Brief 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.

Study Timeline

• Study First Submitted: 2024-12-30
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-07-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paroxetine	Paroxetine	20mg Paroxetine once daily for 12 weeks
Placebo	Placebo	1 placebo capsule containing starch

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Frequency of vasomotor symptoms	Since intervention until 12 weeks	Changes in the frequency of vasomotor symptoms, The incidence of vasomotor symptoms will be assessed at each visit
side effects	Since intervention until 12 weeks	incidence of side effects of paroxetine

Trial Locations

Locations (1)

Instituto Hondureño de Seguridad Social; 🇭🇳 Tegucigalpa, Francisco Morazán, Honduras