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Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric

NCT02749747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-01-14

No results posted yet for this study

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

Conditions

Interventions

DRUG

Sulpiride use

50mg sulpiride once a day use for 60 days

DRUG

Placebo

50mg placebo once a day use for 60 days

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Maria Celeste Osorio Wender · Federal University of Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2017-10-31
Completion
2017-12-31

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02749747 on ClinicalTrials.gov