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PROGESTINS

Dydrogesterone after 60 years: a glance at the safety profile

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Pages 279-287 | Received 09 Jul 2021, Accepted 06 Dec 2021, Published online: 20 Dec 2021

References

  • Peng C, Huang Y, Zhou Y. Dydrogesterone in the treatment of endometriosis: evidence mapping and meta-analysis. Arch Gynecol Obstet. 2021;304(1):231–252.
  • ClinicalTrials.gov [Internet]. Oral dydrogesterone (OD) versus micronized vaginal progesterone (MVP) for luteal phase support (LPS) in IVF/ICSI. Brussel (Belgium): UZ Brussel; 2021 [cited 2021 Apr 22]. Available from https://clinicaltrials.gov/ct2/show/record/NCT03677336.
  • Griesinger G, Blockeel C, Tournaye H. Oral dydrogesterone for luteal phase support in fresh in vitro fertilization cycles: a new standard? Fertil Steril. 2018;109(5):756–762.
  • Stanczyk FZ, Hapgood JP, Winer S, et al. Progestogens used in postmenopausal hormone therapy: differences in their pharmacological properties, intracellular actions, and clinical effects. Endocr Rev. 2013;34(2):171–208.
  • Griesinger G, Tournaye H, Macklon N, et al. Dydrogesterone: pharmacological profile and mechanism of action as luteal phase support in assisted reproduction. Reprod Biomed Online. 2019;38(2):249–259.
  • Mirza FG, Patki A, Pexman-Fieth C. Dydrogesterone use in early pregnancy. Gynecol Endocrinol. 2016;32(2):97–106.
  • Canonico M, Fournier A, Carcaillon L, et al. Postmenopausal hormone therapy and risk of idiopathic venous thromboembolism: results from the E3N cohort study. ATVB. 2010;30(2):340–345.
  • Stevenson JC, Durand G, Kahler E, et al. Oral ultra-low dose continuous combined hormone replacement therapy with 0.5 mg 17β-oestradiol and 2.5 mg dydrogesterone for the treatment of vasomotor symptoms: results from a double-blind, controlled study. Maturitas. 2010;67(3):227–232.
  • Bergeron C, Nogales FF, Rechberger T, et al. Ultra low dose continuous combined hormone replacement therapy with 0.5mg 17beta-oestradiol and 2.5mg dydrogesterone: protection of the endometrium and amenorrhoea rate. Maturitas. 2010;66(2):201–205.
  • Kuba VM, Teixeira MA, Meirelles RM, et al. Dydrogesterone does not reverse the cardiovascular benefits of percutaneous estradiol. Climacteric. 2013;16(1):54–61.
  • Fournier A, Mesrine S, Dossus L, et al. Risk of breast cancer after stopping menopausal hormone therapy in the E3N cohort. Breast Cancer Res Treat. 2014;145(2):535–543.
  • Fournier A, Dossus L, Mesrine S, et al. Risks of endometrial cancer associated with different hormone replacement therapies in the E3N cohort, 1992-2008. Am J Epidemiol. 2014;180(5):508–517.
  • Xue W, Deng Y, Wang YF, et al. Effect of half dose and standard dose conjugated equine estrogens combined with natural progesterone or dydrogesterone on components of metabolic syndrome in healthy postmenopausal women: a randomized controlled. TriaL Chin Med J. 2016;129(23):2773–2779.
  • Piróg M, Jach R, Kacalska-Janssen O. Differential effect of the ultra-low dose and standard estrogen plus dydrogesterone therapy on thrombin generation and fibrinolysis in postmenopausal women. Acta Obstet Gynecol Scand. 2017;96(12):1438–1445.
  • Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of breast cancer: nested case-control studies using the QResearch and CPRD databases. BMJ. 2020;28:371.
  • Song Y, Xu W, Chatooah ND, et al. Comparison of low dose versus ultra-low dose hormone therapy in menopausal symptoms and quality of life in perimenopause women. Gynecol Endocrinol. 2020;36(3):252–256.
  • Tsiligiannis S, Wick-Urban BC, Stam JVD, et al. Efficacy and safety of a low-dose continuous combined hormone replacement therapy with 0.5 mg 17β-estradiol and 2.5 mg dydrogesterone in subgroups of postmenopausal women with vasomotor symptoms. Maturitas. 2020;139:20–26.
  • Salehpour S, Tamimi M, Saharkhiz N. Comparison of oral dydrogesterone with suppository vaginal progesterone for luteal-phase support in in vitro fertilization (IVF): a randomized clinical trial. Iran J Reprod Med. 2013;11(11):913–918.
  • Gopinath PM, Desai RR. Open-label observational study to determine the success rate of first cycle intra uterine insemination (IUI) involving luteal phase support with oral natural or synthetic progesterone. Int J Med Res Health Sci. 2014;3:933–936.
  • Tomic V, Tomic J, Klaic DZ, et al. Oral dydrogesterone versus vaginal progesterone gel in the luteal phase support: randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015;186:49–53.
  • Malhotra J, Krishnaprasad K. Open-label, prospective, investigator initiated study to assess the clinical role of oral Natural or Synthetic Progesterone During Stimulated IUI Cycles for Unexplained Infertility. J Clin Diagn Res. 2016;10(1):QC08.
  • Saharkhiz N, Zamaniyan M, Salehpour S, et al. A comparative study of dydrogesterone and micronized progesterone for luteal phase support during in vitro fertilization (IVF) cycles. Gynecol Endocrinol. 2016;32(3):213–217.
  • Nadarajah R, Rajesh H, Wong KY, et al. Live birth rates and safety profile using dydrogesterone for luteal phase support in assisted reproductive techniques. Singapore Med J. 2017;58(6):294–297.
  • Tournaye H, Sukhikh GT, Kahler E, et al. A phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Hum Reprod. 2017;32(5):1019–1027.
  • Griesinger G, Blockeel C, Sukhikh GT, et al. Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial. Hum Reprod. 2018;33:2212–2221.
  • Huang J, Xie Q, Lin J, et al. Neonatal outcomes and congenital malformations in children born after dydrogesterone application in progestin-primed ovarian stimulation protocol for IVF: a retrospective cohort study. Drug Des Devel Ther. 2019;13:2553–2563.
  • Yang DZ, Griesinger G, Wang W, et al. A phase III randomized controlled trial of oral dydrogesterone versus intravaginal progesterone gel for luteal phase support in in vitro fertilization (lotus II): results from the chinese mainland subpopulation. Gynecol Endocrinol. 2020;36(2):175–183.
  • Atzmon Y, Aslih N, Estrada D, et al. Comparable outcomes using oral dydrogesterone vs. micronized vaginal progesterone in frozen embryo transfer: a retrospective cohort study. Reprod Sci. 2021;28(7):1874–1881.
  • Ozer G, Yuksel B, Yucel Cicek OS, et al. Oral dydrogesterone vs. micronized vaginal progesterone gel for luteal phase support in frozen-thawed single blastocyst transfer in good prognosis patients. J Gynecol Obstet Hum Reprod. 2021;50(5):102030.
  • Chan DMK, Cheung KW, Ko JKY, et al. Use of oral progestogen in women with threatened miscarriage in the first trimester: a randomized double-blind controlled trial. Hum Reprod. 2021;36(3):587–595.
  • Siew JYS, Allen JC, Hui CYY, et al. The randomised controlled trial of micronised progesterone and dydrogesterone (TRoMaD) for threatened miscarriage. Eur J Obstet Gynecol Reprod Biol. 2018;228:319–324.
  • ClinicalTrials.gov. Duphaston in cycle regularization: post-marketing, prospective, multicenter, observational study; [Internet];c2012 [updated 2014 Dec 29; cited 2021 May 21].Available from: https://clinicaltrials.gov/ct2/show/NCT01525563.
  •  ClinicalTrials.gov. Treatment regimen in menstrual cycle regularization and persistence in routine clinical practice in Russia, Ukraine, Kazakhstan and Uzbekistan; [Internet]; c2012 [updated 2015 Dec 22; cited 2021 May 27]. Available from: https://clinicaltrials.gov/ct2/show/NCT01711216.
  • Podzolkova N, Tatarchuk T, Doshchanova A, et al. Dydrogesterone treatment for menstrual-cycle regularization in routine clinical practice: a multicenter observational study. Gynecol Endocrinol. 2016;32(3):246–249.
  • Trivedi N, Chauhan N, Vaidya V. Effectiveness, and safety of dydrogesterone in regularization of menstrual cycle: a post-marketing study. Gynecol Endocrinol. 2016;32(8):667–671.
  • Taniguchi F, Ota I, Iba Y, et al. The efficacy and safety of dydrogesterone for treatment of dysmenorrhea: an open label multicenter clinical study. J Obstet Gynaecol Res. 2019;45(1):168–175.
  • Qu D, Huang X, Yang Y. Combined effect of dydrogesterone and letrozole on humoral immune function, sex hormone levels and serology-related indices in patients with endometriosis. Trop J Pharm Res. 2019;18(2):415–419.
  • Khajehei M, Abdali K, Tabatabaee HR. A comparison between the efficacy of dydrogesterone and calcium plus vitamin D in improving women’s general health. Afr J Psychiatry. 2010;13(3):218–224.
  • Kaur KK, Allahbadia G, Singh M. Luteal phase support using oral dydrogesterone-a prospective treatment for future replacing micronized vaginal progesterone. Open Acc J Repro & Sexual Disord. 2018;1:97–102.
  • Dennerstein L, Morse C, Gotts G, et al. Treatment of premenstrual syndrome. A double-blind trial of dydrogesterone. J Affect Disord. 1979;1(2):77–92.