Sulpiride Versus Placebo for Reducting Hot Flushes During... | NCT02749747

Studies
Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric

NCT02749747

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Completed

Last Update Posted

Jan 14, 2019Actual

Enrollment

28Actual

Phase

Phase 3

Conditions

Menopausal Syndrome
Hot Flashes

Interventions

Sulpiride use
Placebo

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Oct 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Apr 13, 2016

First Submission Date that Met QC Criteria

Apr 22, 2016

First Posted Date

Apr 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2019

Last Update Posted Date

Jan 14, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sulpiride use	Active Comparator	50mg sulpiride once a day use for 60 days	Drug: Sulpiride use
Placebo	Placebo Comparator	50mg placebo once a day use for 60 days	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sulpiride use	Drug	50mg sulpiride once a day use for 60 days	Sulpiride use

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number and severity records of hot flushes	Daily diary of symptoms	From baseline to eight weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Celeste Osorio Wender	Federal University of Rio Grande do Sul	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clínicas de Porto Alegre		Porto Alegre	Rio Grande do Sul	90035903	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12700780	Background	Pedro AO, Pinto Neto AM, Paiva LH, Osis MJ, Hardy E. [Age at natural menopause among Brazilian women: results from a population-based survey]. Cad Saude Publica. 2003 Jan-Feb;19(1):17-25. doi: 10.1590/s0102-311x2003000100003. Epub 2003 Apr 1. Portuguese.
17934658	Background	Vilodre LC, Moretto M, Kohek MB, Spritzer PM. [Premature ovarian failure: present aspects]. Arq Bras Endocrinol Metabol. 2007 Aug;51(6):920-9. doi: 10.1590/s0004-27302007000600005. Portuguese.

Type	Date	Date Unknown
Release	Oct 11, 2019
Reset	Nov 1, 2019

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013469	Sulpiride
D000073893	Sugars

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146