Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause (MENOXTINA)

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

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

Study Overview

• Status: Completed
• Conditions: Hot Flashes; Menopause Surgical; Menopause Syndrome
• Intervention / Treatment: Drug: Paroxetine; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Honduras
  • Francisco Morazán Department
    • Tegucigalpa, Francisco Morazán Department, Honduras, 11101
      • Instituto Hondureño de Seguridad Social

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paroxetine; 20mg Paroxetine once daily for 12 weeks	Drug: Paroxetine; 20 mg PO daily
Placebo Comparator: Placebo; 1 placebo capsule containing starch	Dietary supplement: Placebo; 1 capsule starch; Other Names: Starch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menopause Rating Score (MRS)	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.	Since intervention until 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Nacional Autonoma de Honduras
• Investigators: Study Director: Ricardo A. Gutierrez Ramirez, Universidad Nacional Autonoma de Honduras

Publications and helpful links

General Publications

• Iyer TK, Fiffick AN, Batur P. Nonhormone therapies for vasomotor symptom management. Cleve Clin J Med. 2024 Apr 1;91(4):237-244. doi: 10.3949/ccjm.91a.23067.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2025
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 8, 2025

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Paroxetine; Hot Flashes; Menopause Syndrome; Menopause Surgical
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hot Flashes; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Substandard Drugs; Pharmaceutical Preparations; Dietary Carbohydrates; Carbohydrates; Piperidines; Polymers; Macromolecular Substances; Polysaccharides; Glucans; Biopolymers; Paroxetine; Counterfeit Drugs; Starch
• Other Study ID Numbers: PGO-UNAH-48-2-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not necessary, none of the 18 HIPAA identifiers will be placed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No