Menopausal SyndromePhase 3NCT02749747
Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric
A Phase 3 study testing Sulpiride use in people with Menopausal Syndrome and Hot Flashes, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Syndrome, Hot Flashes
- What is being tested?
- Sulpiride use
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Dec 2017
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy women in postmenopausal women with at least five moderate to intense hot flushes per day
Who cannot join
- 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
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- Abnormal heart rhythm (QT prolongation, bradycardia low 55 beats per minute)
- Hypokalemia and other serious electrolyte disturbances
- Current or treated stroke
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
About this study
Official title: Sulpiride Versus Placebo for Reducting Hot Flushes During Climacteric: a Double-blind Randomized Clinical Trial
- 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
Read the 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.
- Conditions
- Menopausal Syndrome, Hot Flashes
- Being tested
- Sulpiride use, Placebo
- Keywords
- Menopause, nonhormonal treatment, sulpiride
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulpiride useDrug
Also called Sulpirida
50mg sulpiride once a day use for 60 days
PlaceboDrug
Also called Sugar pill
50mg placebo once a day use for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Sulpiride use | Active comparator | 50mg sulpiride once a day use for 60 days Receives: Drug: Sulpiride use |
| Placebo | Placebo comparator | 50mg placebo once a day use for 60 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity records of hot flushes
Daily diary of symptoms
Measured: From baseline to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startJun 2014
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Menopausal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Celeste Osorio Wender, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749747
- Sponsor's protocol ID
- 14-0038
- Status last verified
- Jan 2018
- First submitted
- 13 Apr 2016
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 12700780Vilodre 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.
PubMed 17934658De 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.
PubMed 17160304Wender, 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.
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.
PubMed 26271251Boardman 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.
PubMed 25754617Loprinzi 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.
PubMed 16414336Carroll 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.
PubMed 26124682Umland 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.
PubMed 22870045Pachman 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.
PubMed 21072305Bruscky 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.
PubMed 4408939Simon 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.
PubMed 24569618