Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric

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

Timeline

Start

2014-06

Primary completion

2017-10

Completion

2017-12

Publications

• 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.
• 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.
• Background 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.
• Background 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.
• Results 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 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 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 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 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 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 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 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.

Drugs

Indications

No indication recorded.