Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric: a Double-blind Randomized Clinical Trial
| Registry | NCT02749747 |
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| Status | Completed |
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| Phase | Phase 3 |
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| Study type | Interventional; randomized, parallel, masking: triple, treatment |
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| Enrollment | 28 (Actual) |
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| Sponsor | Hospital de Clinicas de Porto Alegre (Other) |
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| Conditions | Menopausal Syndrome, Hot Flashes |
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| Interventions | Sulpiride use, Placebo (Drug) |
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| Dates | start 2014-06-01, primary completion 2017-10-01, completion 2017-12-01, first posted 2016-04-25, last updated 2019-01-14 |
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| Locations | 1 site in Brazil |
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Related Papers Related Patents Related Grants Related Experts
All trials for Menopausal Syndrome All trials for Hot Flashes All trials of Sulpiride use All trials of Placebo
-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
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Sulpiride use | Active comparator | Drug: Sulpiride use | 50mg sulpiride once a day use for 60 days |
| Placebo | Placebo comparator | Drug: Placebo | 50mg placebo once a day use for 60 days |
- Sulpiride use (Drug), also known as Sulpirida: 50mg sulpiride once a day use for 60 days
- Placebo (Drug), also known as Sugar pill: 50mg placebo once a day use for 60 days
+Outcome measures
Primary outcomes
- Number and severity records of hot flushes [From baseline to eight weeks]: Daily diary of symptoms
+Eligibility
Sex: Female, accepts 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
+Locations (1)
| Facility | City | Country | Status |
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| Hospital de Clínicas de Porto Alegre | Porto Alegre, Rio Grande do Sul | Brazil | |
+Publications
- 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 12700780
- 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 17934658
- 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 17160304
- Wender, M.C. et al. Consenso Brasileiro de Terapêutica Hormonal da Menopausa. SOBRAC - Leitura Médica. 2014.
- Oderich, C. L., Wender, M.C. Climatério. Revista Brasileira de Medicina. 69, 2012.
- Results publication: 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 26271251
- Results publication: 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 25754617
- Results publication: 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 16414336
- Results publication: 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 26124682
- Results publication: 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 22870045
- Results publication: 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 21072305
- Results publication: 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 4408939
- Results publication: 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 24569618
+Investigators