NCT02749747

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2018

Enrollment Period

3.3 years

First QC Date

April 13, 2016

Last Update Submit

January 11, 2019

Conditions

Menopausal SyndromeHot Flashes

Keywords

Menopausenonhormonal treatmentsulpiride

Outcome Measures

Primary Outcomes (1)

  • Number and severity records of hot flushes

    Daily diary of symptoms

    From baseline to eight weeks

Study Arms (2)

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

Sulpiride useDRUG

50mg sulpiride once a day use for 60 days

Also known as: Sulpirida
Sulpiride use
PlaceboDRUG

50mg placebo once a day use for 60 days

Also known as: Sugar pill
Placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy women in postmenopausal women with at least five moderate to intense hot flushes per day

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Publications (13)

  • 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.

    PMID: 12700780BACKGROUND

  • 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.

    PMID: 17934658BACKGROUND

  • 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.

    PMID: 17160304BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 26271251RESULT

  • 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.

    PMID: 25754617RESULT

  • 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.

    PMID: 16414336RESULT

  • 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.

    PMID: 26124682RESULT

  • 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.

    PMID: 22870045RESULT

  • 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.

    PMID: 21072305RESULT

  • 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.

    PMID: 4408939RESULT

  • 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.

    PMID: 24569618RESULT

MeSH Terms

Conditions

Hot Flashes

Interventions

SulpirideSugars

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCarbohydrates

Study Officials

  • Maria Celeste Osorio Wender

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 25, 2016

Study Start

June 1, 2014

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

January 14, 2019

Record last verified: 2018-01

Locations

BR(1)