Hot Flashes Clinical Trial
Official title:
Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric: a Double-blind Randomized Clinical Trial
NCT number | NCT02749747 |
Other study ID # | 14-0038 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | December 2017 |
Verified date | January 2018 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- 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
Status | Completed |
Enrollment | 28 |
Est. completion date | December 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
Boardman HM, Hartley L, Eisinga A, Main C, Roqué 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;(3):CD002229. doi: 10.1002/14 — View Citation
Bruscky SB, Caldeira MV, Bueno JR. [Clinical trial with sulpiride]. Arq Neuropsiquiatr. 1974 Sep;32(3):234-9. Portuguese. — View 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. Review. — View 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. Portuguese. — View Citation
Loprinzi CL, Stearns V, Barton D. Centrally active nonhormonal hot flash therapies. Am J Med. 2005 Dec 19;118 Suppl 12B:118-23. — View Citation
Oderich, C. L., Wender, M.C. Climatério. Revista Brasileira de Medicina. 69, 2012.
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. — View 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. Epub 2003 Apr 1. Portuguese. — View 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. d — View 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/s12905-015-021 — View 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. — View Citation
Vilodre LC, Moretto M, Kohek MB, Spritzer PM. [Premature ovarian failure: present aspects]. Arq Bras Endocrinol Metabol. 2007 Aug;51(6):920-9. Review. Portuguese. — View Citation
Wender, M.C. et al. Consenso Brasileiro de Terapêutica Hormonal da Menopausa. SOBRAC - Leitura Médica. 2014.
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and severity records of hot flushes | Daily diary of symptoms | From baseline to eight weeks |
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