Instituto Hondureño de Seguridad Social
Tegucigalpa, Francisco Morazán Department, 11101, Honduras
NCT Number: NCT06763484
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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Notify Me18 year–80 year
Female
Interventional
Phase 2
Tegucigalpa, Francisco Morazán Department, 11101, Honduras
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
20 mg PO daily
1 capsule starch
Other names: Starch
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.
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
Time frame: Since intervention until 12 weeks
incidence of side effects of paroxetine
Universidad Nacional Autonoma de Honduras
Other
Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause. Randomized Double-blind Clinical Trial
Acronym: MENOXTINA
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