Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric

Phase 3

Completed

• Conditions: Menopausal Syndrome; Hot Flashes
• Interventions: Drug: Placebo; Drug: Sulpiride use

• Registration Number: NCT02749747
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

* 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

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-25
• Primary Completion: 2017-10
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	50mg placebo once a day use for 60 days
Sulpiride use	Sulpiride use	50mg sulpiride once a day use for 60 days

Primary Outcome Measures

Name	Time	Method
Number and severity records of hot flushes	From baseline to eight weeks	Daily diary of symptoms

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil