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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxetine | Experimental | 20mg Paroxetine once daily for 12 weeks |
|
| Placebo | Placebo Comparator | 1 placebo capsule containing starch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paroxetine | Drug | 20 mg PO daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Menopause Rating Score (MRS) | 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. | Since intervention until 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of vasomotor symptoms | Changes in the frequency of vasomotor symptoms, The incidence of vasomotor symptoms will be assessed at each visit | Since intervention until 12 weeks |
| side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo A. Gutierrez Ramirez | Universidad Nacional Autonoma de Honduras | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Hondureño de Seguridad Social | Tegucigalpa | Francisco Morazán Department | 11101 | Honduras |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38561208 | Background | 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. |
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It is not necessary, none of the 18 HIPAA identifiers will be placed
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| D013213 | Starch |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005936 | Glucans |
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parallel-group, efficacy, superiority, double-blind clinical trial
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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.
| Dietary Supplement |
1 capsule starch |
|
|
incidence of side effects of paroxetine
| Since intervention until 12 weeks |
| D001704 |
| Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |