Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Treatments: Sulpiride

Criteria

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