NCT02749747

Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Menopausal Syndrome
• Hot Flashes

Interventions

Type	Name	Description
DRUG	Sulpiride use	50mg sulpiride once a day use for 60 days
DRUG	Placebo	50mg placebo once a day use for 60 days

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2016-04-25
• Last updated: 2019-01-14

Locations

1 site across 1 country: Brazil