Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric

Study Overview
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Brief Summary
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Introduction: Estrogen hormonal therapy associated or not with progestagen is the standard therapy for the treatment of hot flushes. However some women are not candidates for hormone replacement therapy for medical reasons or for choice. Main goal: Reducing the number of hot flushes per week Materials and Methods: A double-blind sulpiride versus placebo that includes selected randomized patients which show symptoms of menopause. The study will be conducted at HC Porto Alegre (Brazil) for 8 weeks of intervention. The expected result is a significant reduction in the number of hot flushes/day evaluated by daily questionnaires

Detailed Description
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It will be held 4 visits. The V0 (first one) to implement the consent form, review the inclusion and exclusion criteria and laboratory exams and deliver the diary book of hot flushes. The V1 (second visit) randomization and provide medication for the first 30 days. The V2 (third visit) to make the record diary of hot flushes already filled, to deliver new specifications and to provide medication for the last 30 days. The V3 (fourth visit) to evaluate the record diary of hot flushes already completed and to make a final evaluation of the study.

Official Title
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Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric: a Double-blind Randomized Clinical Trial

Conditions
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Menopausal Syndrome, Hot Flashes

Intervention / Treatment
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* Drug: Sulpiride use
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women in postmenopausal women with at least five moderate to intense hot flushes per day Exclusion Criteria: Use of hormone replacement therapy or psychiatric drugs for at least 3 months Hypersensitivity to sulpiride Current or history of prolactin dependent tumor Treating breast cancer or treated Diagnosed or suspected pheochromocytoma Current use of levodopa Abnormal heart rhythm (QT prolongation, bradycardia low 55 beats per minute) Hypokalemia and other serious electrolyte disturbances Current or treated stroke Pregnancy or breastfeeding
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sulpiride use<br>50mg sulpiride once a day use for 60 days | Drug: Sulpiride use<br>* 50mg sulpiride once a day use for 60 days<br>* Other names: Sulpirida;|
| Placebo Comparator: Placebo<br>50mg placebo once a day use for 60 days | Drug: Placebo<br>* 50mg placebo once a day use for 60 days<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity records of hot flushes | Daily diary of symptoms | From baseline to eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, nonhormonal treatment, sulpiride