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Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric

Primary Purpose

Menopausal Syndrome, Hot Flashes

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Sulpiride use

Placebo

About this trial

This is an interventional treatment trial for Menopausal Syndrome focused on measuring Menopause, nonhormonal treatment, sulpiride

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sulpiride use

Placebo

Arm Description

50mg sulpiride once a day use for 60 days

50mg placebo once a day use for 60 days

Outcomes

Primary Outcome Measures

Number and severity records of hot flushes

Daily diary of symptoms

Secondary Outcome Measures

Full Information

NCT ID

NCT02749747

First Posted

April 13, 2016

Last Updated

January 11, 2019

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT02749747

Brief Title

Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menopausal Syndrome, Hot Flashes

Keywords

Menopause, nonhormonal treatment, sulpiride

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sulpiride use

Arm Type

Active Comparator

Arm Description

50mg sulpiride once a day use for 60 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

50mg placebo once a day use for 60 days

Intervention Type

Drug

Intervention Name(s)

Sulpiride use

Other Intervention Name(s)

Sulpirida

Intervention Description

50mg sulpiride once a day use for 60 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar pill

Intervention Description

50mg placebo once a day use for 60 days

Primary Outcome Measure Information:

Title

Number and severity records of hot flushes

Description

Daily diary of symptoms

Time Frame

From baseline to eight weeks

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Celeste Osorio Wender

Organizational Affiliation

Federal University of Rio Grande do Sul

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Clínicas de Porto Alegre

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035903

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

12700780

Citation

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.

Results Reference

background

PubMed Identifier

17934658

Citation

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.

Results Reference

background

PubMed Identifier

17160304

Citation

De Lorenzi DR, Baracat EC, Saciloto B, Padilha I Jr. [Factors related to quality of life in post-menopause]. Rev Assoc Med Bras (1992). 2006 Sep-Oct;52(5):312-7. doi: 10.1590/s0104-42302006000500017. Portuguese.

Results Reference

background

Citation

Wender, M.C. et al. Consenso Brasileiro de Terapêutica Hormonal da Menopausa. SOBRAC - Leitura Médica. 2014.

Results Reference

background

Citation

Oderich, C. L., Wender, M.C. Climatério. Revista Brasileira de Medicina. 69, 2012.

Results Reference

background

PubMed Identifier

26271251

Citation

Sussman M, Trocio J, Best C, Mirkin S, Bushmakin AG, Yood R, Friedman M, Menzin J, Louie M. Prevalence of menopausal symptoms among mid-life women: findings from electronic medical records. BMC Womens Health. 2015 Aug 13;15:58. doi: 10.1186/s12905-015-0217-y.

Results Reference

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PubMed Identifier

25754617

Citation

Boardman HM, Hartley L, Eisinga A, Main C, Roque i Figuls M, Bonfill Cosp X, Gabriel Sanchez R, Knight B. Hormone therapy for preventing cardiovascular disease in post-menopausal women. Cochrane Database Syst Rev. 2015 Mar 10;2015(3):CD002229. doi: 10.1002/14651858.CD002229.pub4.

Results Reference

result

PubMed Identifier

16414336

Citation

Loprinzi CL, Stearns V, Barton D. Centrally active nonhormonal hot flash therapies. Am J Med. 2005 Dec 19;118 Suppl 12B:118-23. doi: 10.1016/j.amjmed.2005.09.045.

Results Reference

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PubMed Identifier

26124682

Citation

Carroll DG, Lisenby KM, Carter TL. Critical appraisal of paroxetine for the treatment of vasomotor symptoms. Int J Womens Health. 2015 Jun 18;7:615-24. doi: 10.2147/IJWH.S50804. eCollection 2015.

Results Reference

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PubMed Identifier

22870045

Citation

Umland EM, Falconieri L. Treatment options for vasomotor symptoms in menopause: focus on desvenlafaxine. Int J Womens Health. 2012;4:305-19. doi: 10.2147/IJWH.S24614. Epub 2012 Jul 5.

Results Reference

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PubMed Identifier

21072305

Citation

Pachman DR, Jones JM, Loprinzi CL. Management of menopause-associated vasomotor symptoms: Current treatment options, challenges and future directions. Int J Womens Health. 2010 Aug 9;2:123-35. doi: 10.2147/ijwh.s7721.

Results Reference

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PubMed Identifier

4408939

Citation

Bruscky SB, Caldeira MV, Bueno JR. [Clinical trial with sulpiride]. Arq Neuropsiquiatr. 1974 Sep;32(3):234-9. doi: 10.1590/s0004-282x1974000300010. No abstract available. Portuguese.

Results Reference

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PubMed Identifier

24569618

Citation

Simon JA, Chandler J, Gottesdiener K, Lazarus N, He W, Rosenberg E, Wagner JA, Denker AE. Diary of hot flashes reported upon occurrence: results of a randomized double-blind study of raloxifene, placebo, and paroxetine. Menopause. 2014 Sep;21(9):938-44. doi: 10.1097/GME.0000000000000218.

Results Reference

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Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric

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