Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause

Last updated: January 6, 2025
Sponsor: Universidad Nacional Autonoma de Honduras
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

Paroxetine

Clinical Study ID

NCT06763484
PGO-UNAH-48-2-2025
  • Ages 18-80
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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 toparticipate voluntarily.

Exclusion

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 anyother psychiatric disorder (including substance abuse or alcohol disorders) and anyother ongoing medical condition.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
January 01, 2025
Estimated Completion Date:
September 01, 2025

Study 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.

Connect with a study center

  • Instituto Hondureño de Seguridad Social

    Tegucigalpa, Francisco Morazán 11101
    Honduras

    Active - Recruiting

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