Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause

NCT06763484 | Completed Phase 2 DMC

• 1 other identifier: PGO-UNAH-48-2-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Menopause Syndrome; Menopause Surgical; Hot Flashes

Keywords

Menopause Syndrome; Menopause Surgical; Hot Flashes; Paroxetine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Frequency of vasomotor symptoms

  Since intervention until 12 weeks

• side effects

  Since intervention until 12 weeks

Study Arms (2)

Paroxetine

EXPERIMENTAL

20mg Paroxetine once daily for 12 weeks

Drug: Paroxetine

Placebo

PLACEBO COMPARATOR

1 placebo capsule containing starch

Dietary Supplement: Placebo

Interventions

Paroxetine DRUG

20 mg PO daily

Paroxetine

Placebo DIETARY_SUPPLEMENT

1 capsule starch

Also known as: Starch

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Honduras: lead

Study Sites (1)

Instituto Hondureño de Seguridad Social

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Related Publications (1)

• 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.

  PMID: 38561208 BACKGROUND

MeSH Terms

Conditions

Hot Flashes

Interventions

Paroxetine; Starch

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Ricardo A. Gutierrez Ramirez

  Universidad Nacional Autonoma de Honduras

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To eliminate researcher bias, a third research participant will place the capsules containing the soy isoflavonate in one bottle and the placebo in another bottle. The bottles will be labeled as group A and group B, but the researchers will not know which is in which group, to ensure that the study intervention and the control/placebo are as indistinguishable as possible to the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular professor

Model Details: parallel-group, efficacy, superiority, double-blind clinical trial

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 8, 2025
• Study Start: January 30, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 1, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)