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Completed

NCT Number: NCT02749747

Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric

* 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

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Key information

Conditions

Menopausal Syndrome Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulpiride use

Drug

50mg sulpiride once a day use for 60 days

Other names: Sulpirida

Placebo

Drug

50mg placebo once a day use for 60 days

Other names: Sugar pill

Primary outcomes

  1. Number and severity records of hot flushes

    Time frame: From baseline to eight weeks

    Daily diary of symptoms

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2016
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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