Clinical trial NCT06763484: Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause
Official title: Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause. Randomized Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Menopause Syndrome
Menopause Surgical
Hot Flashes
Keywords: Menopause Syndrome
Menopause Surgical
Hot Flashes
Paroxetine
Lead sponsor: Universidad Nacional Autonoma de Honduras
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-group, efficacy, superiority, double-blind clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Menopause Rating Score (MRS)
timeFrame: Since intervention until 12 weeks
Secondary outcomes:
measure: Frequency of vasomotor symptoms
timeFrame: Since intervention until 12 weeks
measure: side effects
timeFrame: Since intervention until 12 weeks
Other outcomes:
Locations:
city: Tegucigalpa
country: Honduras
facility: Instituto Hondureño de Seguridad Social
state: Francisco Morazán
Study officials:
affiliation: Universidad Nacional Autonoma de Honduras
name: Ricardo A. Gutierrez Ramirez
role: STUDY_DIRECTOR
References:
citation: 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.