drugset / Trial / NCT05346445
Comparison of Fluoxetine Versus Citalopram Therapy to Control Postmenopausal Vasomotor Syndrome
Completed
91 enrolled
Hospital Regional 1o de Octubre
National Polytechnic Institute, Mexico · collabUniversidad Nacional Autonoma de Mexico · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study determined the efficacy of non-hormonal therapy with citalopram compared to fluoxetine, for the treatment of menopausal symptoms in Mexican women with vasomotor syndrome (VMS) and urogenital syndrome.
Timeline
- Start
- 2021-01-20
- Primary completion
- 2021-11-20
- Completion
- 2021-12-20
Publications
- Background El Khoudary SR, McClure CK, VoPham T, Karvonen-Gutierrez CA, Sternfeld B, Cauley JA, Khalil N, Sutton-Tyrrell K. Longitudinal assessment of the menopausal transition, endogenous sex hormones, and perception of physical functioning: the Study of Women's Health Across the Nation. J Gerontol A Biol Sci Med Sci. 2014 Aug;69(8):1011-7. doi: 10.1093/gerona/glt285. Epub 2014 Jan 24.
- Background Jones CM, Boelaert K. The Endocrinology of Ageing: A Mini-Review. Gerontology. 2015;61(4):291-300. doi: 10.1159/000367692. Epub 2014 Nov 27.
- Background Blumel JE, Lavin P, Vallejo MS, Sarra S. Menopause or climacteric, just a semantic discussion or has it clinical implications? Climacteric. 2014 Jun;17(3):235-41. doi: 10.3109/13697137.2013.838948. Epub 2013 Nov 7.
- Background Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199-215. doi: 10.1038/nrendo.2017.180. Epub 2018 Feb 2.
- Background Kim MJ, Yim G, Park HY. Vasomotor and physical menopausal symptoms are associated with sleep quality. PLoS One. 2018 Feb 20;13(2):e0192934. doi: 10.1371/journal.pone.0192934. eCollection 2018.
- Background Sarrel P, Portman D, Lefebvre P, Lafeuille MH, Grittner AM, Fortier J, Gravel J, Duh MS, Aupperle PM. Incremental direct and indirect costs of untreated vasomotor symptoms. Menopause. 2015 Mar;22(3):260-6. doi: 10.1097/GME.0000000000000320.
- Background Avis NE, Crawford SL, Green R. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018 Dec;45(4):629-640. doi: 10.1016/j.ogc.2018.07.005. Epub 2018 Oct 25.
- Background Langer RD, Hodis HN, Lobo RA, Allison MA. Hormone replacement therapy - where are we now? Climacteric. 2021 Feb;24(1):3-10. doi: 10.1080/13697137.2020.1851183. Epub 2021 Jan 6.
- Background Deecher DC, Dorries K. Understanding the pathophysiology of vasomotor symptoms (hot flushes and night sweats) that occur in perimenopause, menopause, and postmenopause life stages. Arch Womens Ment Health. 2007;10(6):247-57. doi: 10.1007/s00737-007-0209-5. Epub 2007 Dec 12.
- Background De Franciscis P, Cobellis L, Fornaro F, Sepe E, Torella M, Colacurci N. Low-dose hormone therapy in the perimenopause. Int J Gynaecol Obstet. 2007 Aug;98(2):138-42. doi: 10.1016/j.ijgo.2007.04.008. Epub 2007 Jun 18.
- Background Stubbs C, Mattingly L, Crawford SA, Wickersham EA, Brockhaus JL, McCarthy LH. Do SSRIs and SNRIs reduce the frequency and/or severity of hot flashes in menopausal women. J Okla State Med Assoc. 2017 May;110(5):272-274.
- Background Kapoor E, Faubion S, Hurt RT, Fischer K, Schroeder D, Fokken S, Croghan IT. A selective serotonin receptor agonist for weight loss and management of menopausal vasomotor symptoms in overweight midlife women: a pilot study. Menopause. 2020 Nov;27(11):1228-1235. doi: 10.1097/GME.0000000000001599.
- Background Ensrud KE, Joffe H, Guthrie KA, Larson JC, Reed SD, Newton KM, Sternfeld B, Lacroix AZ, Landis CA, Woods NF, Freeman EW. Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: a randomized controlled trial. Menopause. 2012 Aug;19(8):848-55. doi: 10.1097/gme.0b013e3182476099.
- Background Wroolie TE, Williams KE, Keller J, Zappert LN, Shelton SD, Kenna HA, Reynolds MF, Rasgon NL. Mood and neuropsychological changes in women with midlife depression treated with escitalopram. J Clin Psychopharmacol. 2006 Aug;26(4):361-6. doi: 10.1097/01.jcp.0000227699.26375.f8.
- Background Shams T, Firwana B, Habib F, Alshahrani A, Alnouh B, Murad MH, Ferwana M. SSRIs for hot flashes: a systematic review and meta-analysis of randomized trials. J Gen Intern Med. 2014 Jan;29(1):204-13. doi: 10.1007/s11606-013-2535-9. Epub 2013 Jul 26.
- Background Soares CN, Arsenio H, Joffe H, Bankier B, Cassano P, Petrillo LF, Cohen LS. Escitalopram versus ethinyl estradiol and norethindrone acetate for symptomatic peri- and postmenopausal women: impact on depression, vasomotor symptoms, sleep, and quality of life. Menopause. 2006 Sep-Oct;13(5):780-6. doi: 10.1097/01.gme.0000240633.46300.fa.
- Background Suvanto-Luukkonen E, Koivunen R, Sundstrom H, Bloigu R, Karjalainen E, Haiva-Mallinen L, Tapanainen JS. Citalopram and fluoxetine in the treatment of postmenopausal symptoms: a prospective, randomized, 9-month, placebo-controlled, double-blind study. Menopause. 2005 Jan-Feb;12(1):18-26. doi: 10.1097/00042192-200512010-00006.
- Background Barton DL, LaVasseur BI, Sloan JA, Stawis AN, Flynn KA, Dyar M, Johnson DB, Atherton PJ, Diekmann B, Loprinzi CL. Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes: NCCTG trial N05C9. J Clin Oncol. 2010 Jul 10;28(20):3278-83. doi: 10.1200/JCO.2009.26.6379. Epub 2010 May 24.
- Background Soares CN, Poitras JR, Prouty J, Alexander AB, Shifren JL, Cohen LS. Efficacy of citalopram as a monotherapy or as an adjunctive treatment to estrogen therapy for perimenopausal and postmenopausal women with depression and vasomotor symptoms. J Clin Psychiatry. 2003 Apr;64(4):473-9. doi: 10.4088/jcp.v64n0419.
- Background Rathnayake N, Lenora J, Alwis G, Lekamwasam S. Cross cultural adaptation and analysis of psychometric properties of Sinhala version of Menopause Rating Scale. Health Qual Life Outcomes. 2018 Aug 6;16(1):161. doi: 10.1186/s12955-018-0977-9.
- Background Jahangiry L, Parviz R, Mirghafourvand M, Khazaee-Pool M, Ponnet K. The psychometric properties of the Persian menopause rating scale. BMC Womens Health. 2020 Aug 12;20(1):172. doi: 10.1186/s12905-020-01027-0.
- Background Ajani K, Nimavat D, Vidja M, Moradiya A, Panchasara D, Bhalodiya S, Miyatra K, Tank KD. Translation, Reliability, and Validity Test of Gujarati Version of Menopause Rating Scale in Postmenopausal Women for Menopause-Related Symptoms. Indian J Community Med. 2021 Jan-Mar;46(1):40-44. doi: 10.4103/ijcm.IJCM_163_20. Epub 2021 Mar 1.
- Background Anagnostis P, Bitzer J, Cano A, Ceausu I, Chedraui P, Durmusoglu F, Erkkola R, Goulis DG, Hirschberg AL, Kiesel L, Lopes P, Pines A, van Trotsenburg M, Lambrinoudaki I, Rees M. Menopause symptom management in women with dyslipidemias: An EMAS clinical guide. Maturitas. 2020 May;135:82-88. doi: 10.1016/j.maturitas.2020.03.007. Epub 2020 Mar 16.
- Background Guthrie KA, Larson JC, Ensrud KE, Anderson GL, Carpenter JS, Freeman EW, Joffe H, LaCroix AZ, Manson JE, Morin CM, Newton KM, Otte J, Reed SD, McCurry SM. Effects of Pharmacologic and Nonpharmacologic Interventions on Insomnia Symptoms and Self-reported Sleep Quality in Women With Hot Flashes: A Pooled Analysis of Individual Participant Data From Four MsFLASH Trials. Sleep. 2018 Jan 1;41(1):zsx190. doi: 10.1093/sleep/zsx190.
- Background Belso N, Kiss K, Rihmer Z, Tuzko N, Toth SJ, Paulin F. Major depressive disorder and response to citalopram treatment in women attending menopause clinic. Int J Psychiatry Clin Pract. 2003;7(4):269-72. doi: 10.1080/13651500310003183.
- Background Freeman MP, Hill R, Brumbach BH. Escitalopram for perimenopausal depression: an open-label pilot study. J Womens Health (Larchmt). 2006 Sep;15(7):857-61. doi: 10.1089/jwh.2006.15.857.
- Background Soares CN, Thase ME, Clayton A, Guico-Pabia CJ, Focht K, Jiang Q, Kornstein SG, Ninan P, Kane CP, Cohen LS. Desvenlafaxine and escitalopram for the treatment of postmenopausal women with major depressive disorder. Menopause. 2010 Jul;17(4):700-11. doi: 10.1097/gme.0b013e3181d88962.
- Background Barton DL, Loprinzi CL, Novotny P, Shanafelt T, Sloan J, Wahner-Roedler D, Rummans TA, Christensen B, Dakhill SR, Martin LS. Pilot evaluation of citalopram for the relief of hot flashes. J Support Oncol. 2003 May-Jun;1(1):47-51.
- Background Defronzo Dobkin R, Menza M, Allen LA, Marin H, Bienfait KL, Tiu J, Howarth J. Escitalopram reduces hot flashes in nondepressed menopausal women: A pilot study. Ann Clin Psychiatry. 2009 Apr-Jun;21(2):70-6.
- Background Freedman RR, Kruger ML, Tancer ME. Escitalopram treatment of menopausal hot flashes. Menopause. 2011 Aug;18(8):893-6. doi: 10.1097/gme.0b013e31820ccae9.
- Background LaCroix AZ, Freeman EW, Larson J, Carpenter JS, Joffe H, Reed SD, Newton KM, Seguin RA, Sternfeld B, Cohen L, Ensrud KE. Effects of escitalopram on menopause-specific quality of life and pain in healthy menopausal women with hot flashes: a randomized controlled trial. Maturitas. 2012 Dec;73(4):361-8. doi: 10.1016/j.maturitas.2012.09.006. Epub 2012 Sep 30.
- Background Carpenter JS, Guthrie KA, Larson JC, Freeman EW, Joffe H, Reed SD, Ensrud KE, LaCroix AZ. Effect of escitalopram on hot flash interference: a randomized, controlled trial. Fertil Steril. 2012 Jun;97(6):1399-404.e1. doi: 10.1016/j.fertnstert.2012.03.001. Epub 2012 Apr 3.
- Background Joffe H, Guthrie KA, Larson J, Cohen LS, Carpenter JS, Lacroix AZ, Freeman EW. Relapse of vasomotor symptoms after discontinuation of the selective serotonin reuptake inhibitor escitalopram: results from the menopause strategies: finding lasting answers for symptoms and health research network. Menopause. 2013 Mar;20(3):261-8. doi: 10.1097/GME.0b013e31826d3108.
- Background Diem SJ, LaCroix AZ, Reed SD, Larson JC, Newton KM, Ensrud KE, Woods NF, Guthrie KA. Effects of pharmacologic and nonpharmacologic interventions on menopause-related quality of life: a pooled analysis of individual participant data from four MsFLASH trials. Menopause. 2020 Oct;27(10):1126-1136. doi: 10.1097/GME.0000000000001597.
- Background Freeman EW, Guthrie KA, Caan B, Sternfeld B, Cohen LS, Joffe H, Carpenter JS, Anderson GL, Larson JC, Ensrud KE, Reed SD, Newton KM, Sherman S, Sammel MD, LaCroix AZ. Efficacy of escitalopram for hot flashes in healthy menopausal women: a randomized controlled trial. JAMA. 2011 Jan 19;305(3):267-74. doi: 10.1001/jama.2010.2016.
- Background Davari-Tanha F, Soleymani-Farsani M, Asadi M, Shariat M, Shirazi M, Hadizadeh H. Comparison of citalopram and venlafaxine's role in treating sleep disturbances in menopausal women, a randomized, double-blind, placebo-controlled trial. Arch Gynecol Obstet. 2016 May;293(5):1007-13. doi: 10.1007/s00404-015-3900-1. Epub 2015 Oct 5.
- Background Shirazi M, Jalalian MN, Abed M, Ghaemi M. The Effectiveness of Melissa Officinalis L. versus Citalopram on Quality of Life of Menopausal Women with Sleep Disorder: A Randomized Double-Blind Clinical Trial. Rev Bras Ginecol Obstet. 2021 Feb;43(2):126-130. doi: 10.1055/s-0040-1721857. Epub 2021 Jan 19.
- Background Molaie M, Darvishi B, Jafari Azar Z, Shirazi M, Amin G, Afshar S. Effects of a combination of Nigella sativa and Vitex agnus-castus with citalopram on healthy menopausal women with hot flashes: results from a subpopulation analysis. Gynecol Endocrinol. 2019 Jan;35(1):58-61. doi: 10.1080/09513590.2018.1499086. Epub 2018 Aug 21.
- Background Valdes-Sustaita B, Lopez-Rubalcava C, Gonzalez-Trujano ME, Garcia-Viguera C, Estrada-Camarena E. Aqueous Extract of Pomegranate Alone or in Combination with Citalopram Produces Antidepressant-Like Effects in an Animal Model of Menopause: Participation of Estrogen Receptors. Int J Mol Sci. 2017 Dec 19;18(12):2643. doi: 10.3390/ijms18122643.
- Background Zhou J, Wang X, Feng L, Xiao L, Yang R, Zhu X, Shi H, Hu Y, Chen R, Boyce P, Wang G. Venlafaxine vs. fluoxetine in postmenopausal women with major depressive disorder: an 8-week, randomized, single-blind, active-controlled study. BMC Psychiatry. 2021 May 19;21(1):260. doi: 10.1186/s12888-021-03253-8.
- Rios-Espinosa A, Cruz-Luna M, Garmendia-Gallardo C, Hernandez-Castanon MY, Hernandez-Hernandez VY, Sanchez-Tinoco PM, Bajonero-Dominguez A, Vergara Lope-Nunez JA, Alvarez-Perez MA, Gonzalez-Quiroz JL, Loranca-Moreno P, Ocampo-Godinez JM. Citalopram improves vasomotor syndrome and urogenital syndrome of menopause in Mexican women: a randomized clinical trial. Arch Gynecol Obstet. 2022 Dec;306(6):2035-2045. doi: 10.1007/s00404-022-06732-9. Epub 2022 Aug 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Citalopram | Small molecule | 20 mg | Oral |
| Comparator | Fluoxetine | Small molecule | 20 mg | Oral |
Indications
No indication recorded.