Hot Flashes, Menopause Surgical, Menopause Syndrome
Conditions
Keywords
Menopause Syndrome, Menopause Surgical, Hot Flashes, Paroxetine
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.
Interventions
DRUGParoxetine
20 mg PO daily
DIETARY_SUPPLEMENTPlacebo
1 capsule starch
Sponsors
Universidad Nacional Autonoma de Honduras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
parallel-group, efficacy, superiority, double-blind clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menopause Rating Score (MRS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of vasomotor symptoms | Since intervention until 12 weeks | Changes in the frequency of vasomotor symptoms, The incidence of vasomotor symptoms will be assessed at each visit |
| side effects | Since intervention until 12 weeks | incidence of side effects of paroxetine |
Countries
Honduras
Outcome results
None listed