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Completed

NCT Number: NCT06763484

Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause

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

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Instituto Hondureño de Seguridad Social

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

paroxetine

Drug

20 mg PO daily

Placebo

Dietary Supplement

1 capsule starch

Other names: Starch

Primary outcomes

  1. Menopause Rating Score (MRS)

    Time frame: 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 outcomes

  1. Frequency of vasomotor symptoms

    Time frame: Since intervention until 12 weeks

    Changes in the frequency of vasomotor symptoms, The incidence of vasomotor symptoms will be assessed at each visit

  2. side effects

    Time frame: Since intervention until 12 weeks

    incidence of side effects of paroxetine

Sponsors and collaborators

Lead sponsor

Universidad Nacional Autonoma de Honduras

Other

Registry information

Official study title

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

Acronym: MENOXTINA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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