Promestriene: Evaluation of the impact on serum estradiol levels in women with breast cancer and genitourinary syndrome of menopause. Armenia, Colombia, 2017-2018

Promestrieno: evaluación del impacto en los niveles séricos de estradiol, en mujeres con cáncer de mama y síndrome genitourinario de la menopausia. Armenia,Colombia, 2017-2018 Promestrieno: evaluación del impacto en los niveles séricos de estradiol, en mujeres con cáncer de mama y síndrome genitourinario de la menopausia. Armenia,Colombia, 2017-2018

Published 2022-12-05


https://doi.org/10.30554/archmed.22.2.4036.2022
Open | Download
HTML (Spanish) XML (Spanish) epub (Spanish) PDF (Spanish) FLIP
Issue
Vol. 22 No. 2 (2022): .
Section
Artículos de Investigación
How to Cite
Espitia De La Hoz, F. J. (2022). Promestriene: Evaluation of the impact on serum estradiol levels in women with breast cancer and genitourinary syndrome of menopause. Armenia, Colombia, 2017-2018: Promestrieno: evaluación del impacto en los niveles séricos de estradiol, en mujeres con cáncer de mama y síndrome genitourinario de la menopausia. Armenia,Colombia, 2017-2018. Archivos De Medicina , 22(2). https://doi.org/10.30554/archmed.22.2.4036.2022
Download Citation
Endnote/Zotero/Mendeley (RIS) BibTeX
DOI

https://doi.org/10.30554/archmed.22.2.4036.2022
Dimensions
PlumX

How to Cite

Espitia De La Hoz, F. J. (2022). Promestriene: Evaluation of the impact on serum estradiol levels in women with breast cancer and genitourinary syndrome of menopause. Armenia, Colombia, 2017-2018: Promestrieno: evaluación del impacto en los niveles séricos de estradiol, en mujeres con cáncer de mama y síndrome genitourinario de la menopausia. Armenia,Colombia, 2017-2018. Archivos De Medicina , 22(2). https://doi.org/10.30554/archmed.22.2.4036.2022

Download Citation

license
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Objective: To assess the variations in serum estradiol levels in women with breast cancer and genitourinary syndrome of menopause, after the administration of local intravaginal promestriene.

Materials and methods: Randomized, double-blind, controlled clinical trial. 92 women older than 40 years, treated for HER2-positive breast cancer, resident in Armenia, Colombia; with symptoms of genitourinary syndrome of menopause (SGUM), six months after completing oncological therapy; between March 2017 and March 2018. Postmenopausal status was defined as 12 months of amenorrhea or 6 months of amenorrhea with serum FSH levels ≥ 40 mIU / mL or estradiol <30 pg / mL. Two groups were assigned: group "A" (n = 45, promestriene) and group "B" (n = 47, placebo). Those in group "A" received 10 mg intravaginally, per day, for 21 consecutive days, continuing 10 mg weekly for three months, then every 2 weeks until the end of the study. Those in group "B" received placebo in the same way. The serum concentration of estradiol, sex hormone transporter globulin, free and total testosterone, as well as follicle-stimulating hormone and lute-stimulating hormone (at the start of therapy, then every three months, and at the end of the study at twelve months) were measured.

Results: The mean age was 55.26 ± 5.28 years. Sociodemographic characteristics were similar in both groups, p> 0.05. At the beginning of the study, there were no differences regarding the concentration of estradiol 29.37 ± 8.46 pg / mL (promestriene group); 28.29 ± 7.38 pg / mL (placebo group), p> 0.05. At the end of the study, the results showed no statistically significant differences between both groups: 33.16 ± 7.53 pg / mL versus 30.75 ± 6.93 pg / mL, respectively (p> 0.05).

Conclusions: Local hormonal therapy with promestriene, in the treatment of genitourinary syndrome of menopause, in women with a history of breast cancer, provides clinical evidence of its efficacy and safety, with a negligible impact on estradiol serum levels.

Article visits 341 | PDF visits 222

Downloads

Download data is not yet available.
  1. Bibliografía
  2. Ghoncheh M, Pournamdar Z, Salehiniya H. Incidence and Mortality and Epidemiology of Breast Cancer in the World. Asian Pac J Cancer Prev. 2016; 17(S3):43-6. DOI: https://doi.org/10.7314/apjcp.2016.17.s3.43
  3. Espitia-De La Hoz FJ, De León-Ospina D. Evaluación de la Función sexual en mujeres con cáncer de mama, en el Quindío. Avances En Salud. 2019; 3(2):8-17. DOI: https://doi.org/10.21897/25394622.1754
  4. Fisher B, Costantino JP, Wickerham DL, Cecchini RS, Cronin WM, Robidoux A, Bevers TB, et al. Tamoxifen for the prevention of breast cancer: current status of the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Natl Cancer Inst. 2005; 97(22):1652-62. DOI: https://doi.org/10.1093/jnci/dji372
  5. Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Nikšić M, et al. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018; 391(10125):1023-75. DOI: https://doi.org/10.1016/S0140-6736(17)33326-3
  6. Furr BJ, Jordan VC. The pharmacology and clinical uses of tamoxifen. Pharmacol Ther. 1984; 25(2):127-205. DOI: https://doi.org/10.1016/0163-7258(84)90043-3
  7. Espitia-De La Hoz FJ. Prevalence of genitourinary syndrome of menopause and impact on sexuality of women in Quindío (Colombia), 2013-2016. Rev Colomb Obstet Ginecol.2018; 69(4):249-59. DOI: http://dx.doi.org/10.18597/rcog.3111
  8. Espitia-De La Hoz FJ, Orozco Gallego H. Abordaje diagnóstico y terapéutico del síndrome genitourinario en la menopausia; actualización. Rev Med UCR. 2017; 117:67-84. DOI: https://doi.org/10.15517/rmucr.v11i2.34580
  9. Palacios S, Nappi RE, Bruyniks N, Particco M, Panay N; EVES Study Investigators. The European Vulvovaginal Epidemiological Survey (EVES): prevalence, symptoms and impact of vulvovaginal atrophy of menopause. Climacteric. 2018; 21(3):286-91. DOI: https://doi.org/10.1080/13697137.2018.1446930
  10. Moral E, Delgado JL, Carmona F, Caballero B, Guillán C, González PM, et al. Genitourinary syndrome of menopause. Prevalence and quality of life in Spanish postmenopausal women. The GENISSE study. Climacteric. 2018; 21(2):167-73. DOI: https://doi.org/10.1080/13697137.2017.1421921
  11. The NAMS 2017 Hormone Therapy Position Statement Advisory Panel. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause: The Journal of The North American Menopause Society 2017; 24:728-53. DOI: https://doi.org/10.1097/GME.0000000000000921
  12. Kratz A, Ferraro M, Sluss PM, Lewandrowski KB. Case records of the Massachusetts General Hospital. Weekly clinicopathological exercises. Laboratory reference values. N Engl J Med. 2004; 351(15):1548-63. DOI: https://doi.org/ 10.1056/NEJMcpc049016
  13. Blümel JE, Binfa L, Cataldo P, Carrasco A, Izaguirre H, Sarrá S. Índice de función sexual femenina: un test para evaluar la sexualidad de la mujer. Rev Chil Obstet Ginecol. 2004; 69(2):118-25. DOI: http://dx.doi.org/10.4067/S0717-75262004000200006
  14. Espitia-De La Hoz FJ. Prevalence and characterisation of sexual dysfunctions in women, in 12 colombian cities, 2009-2016. Rev Colomb Obstet Ginecol. 2018; 69 (1):9-21. DOI: http://dx.doi.org /10.18597/rcog.3035
  15. Espitia-De La Hoz FJ. Evaluación de la prevalencia de disfunción sexual en mujeres médicos, del Eje Cafetero colombiano, en etapa de climaterio. Arch Med (Manizales). 2017; 17(1):70-7. DOI: https://doi.org/10.30554/archmed.17.1.1897.2017
  16. World Medical Association (WMA). WMA Declaration of Helsinki – Ethical principles for medical research involving human subjects. Fortaleza: 64th WMA General Assembly; 2013.
  17. Colombia. Ministerio de Salud. Resolución 8430 de 1993 (oc-tubre 4): Por la cual se establecen las normas científicas, técnicas y administrativas para la investigación en salud. Bogotá D.C.: octubre 4 de 1993.
  18. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002; 106(25):3143-3421.
  19. Palacios S, Cancelo MJ. Clinical update on the use of ospemifene in the treatment of severe symptomatic vulvar and vaginal atrophy. Int J Womens Health. 2016; 8:617-26. DOI: https://doi.org/10.2147/IJWH.S110035
  20. Espitia-De La Hoz FJ, Orozco Gallego H. Evaluación de la eficacia de la combinación de dos terapias estrogénicas locales más un lubricante vaginal, para el control de los síntomas del síndrome genitourinario de la menopausia. Revista Investigaciones Andina. 2018; 21(38):167-83. DOI: https://doi.org/10.33132/01248146.998
  21. De Aloysio D, Pennacchioni P, Bonino S. Rational use of vaginal promestriene. Ital J Obstet Gynecol 1995; 9:533–8.
  22. Santos I, Clissold S. Urogenital disorders associated with oestrogen deficiency: the role of promestriene as topical oestrogen therapy. Gynecological Endocrinology, September. 2010; 26(9): 644–51. DOI: http://dx.doi.org/10.3109/09513591003767948
  23. Trinkaus M, Chin S, Wolfman W, et al. Should urogenital atrophy in breast cancer survivors be treated with topical estrogens? Oncologist 2008; 13:222-231. DOI: 10.1634/theoncologist.2007-0234
  24. Biglia N, Bounous VE, Sgro LG, D'Alonzo M, Pecchio S, Nappi RE. Genitourinary Syndrome of Menopause in Breast Cancer Survivors: Are We Facing New and Safe Hopes? Clin Breast Cancer. 2015; 15(6):413-20. DOI: 10.1016/j.clbc.2015.06.005
  25. Ponzone R, Biglia N, Jacomuzzi ME, Maggiorotto F, Mariani L, Sismondi P. Vaginal oestrogen therapy after breast cancer: is it safe? Eur J Cancer. 2005; 41(17):2673-81. DOI: 10.1016/j.ejca.2005.07.015
  26. Wolff JP, Cachelou R, Guéritée N. Absence of systemic hormonal effects in an oestradiol diether topically active on the vaginal mucosa. Maturitas 1982; 4(4):239-46. DOI: https://doi.org/10.1016/0378-5122(82)90054-8
  27. Kabir F, Jahan N, Sultana N, Akter R. Lipid Profile Status In Surgical Menopause. Journal of Bangladesh Society of Physiologist, 6(2):127-133. DOI: https://doi.org/10.3329/jbsp.v6i2.9763
  28. Del Pup L. Management of vaginal dryness and dyspareunia in estrogen sensitive cancer patients. Gynecol Endocrinol 2012; 28:740–5. DOI: http://dx.doi.org/10.3109/09513590.2011.652717
  29. Pfeiler G, Glatz C, Königsberg R, Geisendorfer T, Fink-Retter A, Kubista E, Singer CF, Seifert M. Vaginal estriol to overcome side-effects of aromatase inhibitors in breast cancer patients. Climacteric. 2011; 14(3):339-44. DOI: 10.3109/13697137.2010.529967
  30. Biglia N, Peano E, Sgandurra P, Moggio G, Panuccio E, Migliardi M, et al. Low-dose vaginal estrogens or vaginal moisturizer in breast cancer survivors with urogenital atrophy: a preliminary study. Gynecol Endocrinol. 2010; 26(6):404-12. DOI: 10.3109/09513591003632258
  31. Melisko ME, Goldman M, Rugo HS. Amelioration of sexual adverse effects in the early breast cancer patient. J Cancer Surviv. 2010; 4:247–55. DOI: https://doi.org/10.1007/s11764-010-0130-1
  32. Palacios Gil Antunano S, Peralta J, Mujica I, Fernandez Villoria E. Assessing estradiol diether systemic effects in premenopausal and postmenopausal women. Presented at the 19th National Congress of Gynecology, 22–24 October, Oviedo, Spain; 1987.
  33. Romanini C, Villani L, Pasqua M, Gaglione R, Fischetti C, Fornara CF. Traitement prolonge´ de la vaginite atrophique par promestriene. Resultats et tolerance. Gynecologie 1980; 31:627–31.
  34. Wurch TA, Lumbroso M, Becker JF. Getting evidence of the lack of systemic effect promestriene used at high doses. Gynecocology 1988; 39:101–3.
  35. Bonneton A, Dechaud H, Fleury MC, Colau JC, Pugeat M. Lack of influence of promestriene vaginally administered on circulating levels of hormones and estrogen dependent hepatic proteins in postmenopausal women. Gynecocology 1992; 43:45–8.
  36. Vors J, Muller P. Trophicité vaginale et Colpotrophine. Med Gen 1975; 1 November 1.
  37. Campana G, Di Grancesco. Sindrome climaterica: esperienze cliniche con il promestriene [Climacteric syndrome: clinical experiences using promestriene]. Ann Ostet Ginecol Med Perinat. 1976; 97(3):189-97.
  38. Villani L, Romanini C, Fornara CF, et al. Trophic disorders in gynecology seniors. Clinical aspects, index vulvar pathology, vaginal and cervical. Action promestriene. Medicine and 3rd Age 1978; 1:315–21.
  39. Sun AJ, Lin SQ, Jing LH, Wang ZY, Ye JL, Zhang Y. Safety of promestriene capsule used in postmenopausal atrophic vaginitis. Zhonghua Fu Chan Ke Za Zhi. 2009; 44(8):593-6.
  40. Pompei L de Melo, Fernandes CE, Melo NR. Promestrieno no tratamento da atrofia vulvovaginal: revisão sistemática / Promestriene for treatment of vulvovaginal atrophy: a systematic review. Femina. 2010; 38(7):359-65.

Information

Keywords

QR code

Sistema OJS 3.4.0.10 - Metabiblioteca |