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Disfonksiyonel uterin kanamanın tedavisinde mikronize vajinal progesteron ile oral didrogestronun karşılaştırılması: etkinlikleri ve lipid profili üzerindeki etkileri

Year 2021, Volume: 46 Issue: 1, 32 - 38, 31.03.2021

Abstract

Amaç: Bu çalışmanın amacı, kısa süreli oral didrogesteron ile vajinal mikronize progesteronun etkinliğini karşılaştırmayı ve disfonksiyonel uterin kanamalı premenopozal kadınlarda lipid profili üzerindeki etkilerini belirlemeyi amaçlamaktadır.
Gereç ve Yöntem: Disfonksiyonel uterin kanaması olan toplam 70 premenopozal kadın, çalışmaya dahil edildi. 35 hastaya (Grup 1) 90 mg vajinal mikronize progesteron (% 8 jel), diğer 35 hastaya20 mg oral didrogesteron (Grup 2) almak üzere rastgele atandı. Grup 1 tedavisi, adet döngüsünün 17. ila 27. günü arasında her akşam üç döngü boyunca kendi kendine vajinal progesteron uygulamasından oluşuyordu. Grup 2'deki hastalar menstrüel siklusun 15. gününden başlayarak 10 gün süreyle günde iki kez 10 mg oral didrogesteron ile üç döngü boyunca tedavi edildi.
Bulgular: Üç kür vajinal progesteron tedavisinden sonra vücut kitle indeksi anlamlı olarak artarken, oral didrogesteron tedavisi sonrası vücut kitle indeksi ve serum LDL konsantrasyonu anlamlı olarak arttı. Her iki grupta da tedavinin tamamlanmasından sonra sekretuar endometriumlu hasta sayısı anlamlı olarak arttı.
Sonuç: Mikronize progesteronun vajinal uygulaması, disfonksiyonel uterin kanamasının tedavisinde oral progestinlere bir alternatif olabilir. Vajinal mikronize progesteron tedavisi oral progestin tedavisi kadar etkili görünmektedir ve aynı zamanda kolay uygulama avantajına sahip olduğu ve lipid profili üzerinde hiçbir yan etkisi olmadığı görülmektedir.

References

  • Referans1.Davidson BR, Dipiero CM, Govoni KD, Littleton SS, Neal JL. Abnormal uterine bleeding during the reproductive years. J Midwifery Womens Health. 2012; 57(3): 248-54.
  • Referans2.Tsai MC, Goldstein SR. Office diagnosis and management of abnormal uterine bleeding. Clin Obstet Gynecol. 2012; 55(3): 635-50.
  • Referans3.Bitzer J, Heikinheimo O, Nelson AL, Calaf-Alsina J, Fraser IS. Medical management of heavy menstrual bleeding: a comprehensive review of the literature. Obstet Gynecol Surv. 2015; 70(2): 115-30.
  • Referans4.Hillard PA. Menstrual suppression: current perspectives. Int J Womens Health. 2014; 6: 631-7.
  • Referans5.Schindler AE. Progestational effects of dydrogesterone in vitro, in vivo and on the human endometrium. Maturitas. 2009; 65 Suppl. 1: S3-11.
  • Referans6.Karakus S, Kiran G, Ciralik H. Efficacy of micronised vaginal progesterone versus oral dydrogestrone in the treatment of irregulardysfunctional uterine bleeding: a pilot randomised controlled trial. Aust N Z J Obstet Gynaecol. 2009; 49(6): 685-8.
  • Referans7.Royer PA, Jones KP. Progestins for contraception: modern delivery systems and novel formulations. Clin Obstet Gynecol. 2014; 57(4): 644-58.
  • Referans8.Kostova P, Zlatkov V. Clinical study on the effect of vaginal administration of micronized progesterone at dysfunctional uterinebleeding in premenopause. Akush Ginekol (Sofiia). 2009; 48(2): 3-7.
  • Referans9.Deligeoroglou E, Creatsas G. Menstrual disorders. Endocr Dev 2012; 22: 160-70.
  • Referans10.Hickey M, Higham JM, Fraser I. Progestogens with or without estrogen for irregular uterine bleeding associated with anovulation. Cochrane Database Syst Rev. 2012: 12; 9: CD001895.
  • Referans11.Paulson RJ, Collins MG, Yankov VI. Progesterone pharmacokinetics and pharmacodynamics with 3 dosages and 2 regimens of an effervescent micronized progesterone vaginal insert. J Clin Endocrinol Metab. 2014; 99(11): 4241-9.
  • Referans12.Africander D, Verhoog N, Hapgood JP. Molecular mechanisms of steroid receptor-mediated actions by synthetic progestins used in HRT and contraception. Steroids. 2011; 76(7): 636-52.
  • Referans13.Sitruk-Ware R. Pharmacology of different progestogens: the special case of drospirenone. Climacteric. 2005; 8(3): 4-12.
  • Referans14.Fujiwara T. A multi-center, randomized, open-label, parallel group study of a natural micronized progesteronevaginal tablet as a luteal support agent in Japanese women undergoing assisted reproductive technology. Reprod Med Biol 2015;14(4): 185-193.
  • Referans15.Coomarasamy A, Williams H, Truchanowicz E, Seed PT, Small R, Quenby S, et al. A Randomized Trial of Progesterone in Women with Recurrent MiscarriagesN Engl J Med 2015; 373(22): 2141-8.
  • Refarans16.Fernández-Murga L, Hermenegildo C, Tarín JJ, García-Pérez MÁ, Cano A. Endometrial response to concurrent treatment with vaginal progesterone and transdermal estradiol. Climacteric 2012;15(5): 455-9.
  • Referans17.Di Carlo C, Tommaselli GA, Gargano V, Savoia F, Bifulco G, Nappi C. Transdermal estradiol and oral or vaginal natural progesterone: bleeding patterns. Climacteric 2010; 13(5): 442-6.
  • Referans18.Nath A, Sitruk-Ware R. Different cardiovascular effects of progestins according to structure and activity. Climacteric 2009; 12(1): 96–101.
  • Referans19.Sitruk-Ware R, Nath A. Metabolic effects of contraceptive steroids. Rev Endocr Metab Disord 2011; 12(2): 63-75.
  • Referans20.Rafie S, Borgelt L, Koepf ER, Temple-Cooper ME, Lehman KJ. Novel oral contraceptive for heavy menstrual bleeding: estradiol valerate and dienogest. Int J Womens Health 2013; 5: 313-21.
  • Referans21.Spritzer PM, Vitola D, Vilodre LC, Wender MC, Reis FM, Ruschel S, et al.One year follow-up of hormone replacement therapy with percutaneous estradiol and low-dose vaginal natural progesterone in women with mild to moderate hypertension. Exp Clin Endocrinol Diabetes 2003; 111(5): 267–73.
  • Referans22.Bukowska H, Stanosz S, Zochowska E, Millo B, Sieja K, Chelstowski K, et al. Does the type of hormone replacement therapy affect lipoprotein (a), homocysteine, and C-reactive protein levels in postmenopausal women? Metabolism 2005;54(1): 72–8.
  • Referans23.Casanova G, Spritzer PM. Effects of micronized progesterone added to non-oral estradiol on lipids and cardiovascular risk factors in early postmenopause: a clinical trial. Lipids Health Dis 2012; 11: 133.

Micronised vaginal progesterone versus oral dydrogestrone in the treatment of dysfunctional uterine bleeding: efficacy and effects on lipid profile

Year 2021, Volume: 46 Issue: 1, 32 - 38, 31.03.2021

Abstract

Purpose: The aim of this study was to compare the efficacy of short-course oral dydrogesterone versus vaginal micronized progesterone and to determine their effects on the lipid profile of the premenopausal women with dysfunctional uterine bleeding.
Materials and Methods: A total of 70 premenopausal women with dysfunctional uterine bleeding were randomly assigned to receive 90 mg of vaginal micronized progesterone (8% gel) (Group 1, n = 35) or 20 mg of oral dydrogesterone (Group 2, n = 35). The group 1 treatment consisted of self-application of vaginal progesterone, every other evening from the 17th to the 27th day of the menstrual cycle, for three cycles. The patients in Group 2 were treated with dydrogesterone 10 mg orally twice daily for 10 days, starting from the 15th day of the menstrual cycle, for three cycles.
Results: Body mass index increased significantly after three cycles of vaginal progesterone treatment whereas body mass index and serum LDL concentration increased significantly after three cycles of oral dydrogesterone treatment. The number of patients with secretory endometrium increased significantly after the completion of treatment in both groups.
Conclusion: Vaginal administration of micronized progesterone may be an alternative to oral progestins in the treatment of dysfunctional uterine bleeding. Vaginal micronized progesterone treatment seems to be as effective as oral progestin treatment and it also appears to have the advantage of easy application and no adverse effects on the lipid profile.

References

  • Referans1.Davidson BR, Dipiero CM, Govoni KD, Littleton SS, Neal JL. Abnormal uterine bleeding during the reproductive years. J Midwifery Womens Health. 2012; 57(3): 248-54.
  • Referans2.Tsai MC, Goldstein SR. Office diagnosis and management of abnormal uterine bleeding. Clin Obstet Gynecol. 2012; 55(3): 635-50.
  • Referans3.Bitzer J, Heikinheimo O, Nelson AL, Calaf-Alsina J, Fraser IS. Medical management of heavy menstrual bleeding: a comprehensive review of the literature. Obstet Gynecol Surv. 2015; 70(2): 115-30.
  • Referans4.Hillard PA. Menstrual suppression: current perspectives. Int J Womens Health. 2014; 6: 631-7.
  • Referans5.Schindler AE. Progestational effects of dydrogesterone in vitro, in vivo and on the human endometrium. Maturitas. 2009; 65 Suppl. 1: S3-11.
  • Referans6.Karakus S, Kiran G, Ciralik H. Efficacy of micronised vaginal progesterone versus oral dydrogestrone in the treatment of irregulardysfunctional uterine bleeding: a pilot randomised controlled trial. Aust N Z J Obstet Gynaecol. 2009; 49(6): 685-8.
  • Referans7.Royer PA, Jones KP. Progestins for contraception: modern delivery systems and novel formulations. Clin Obstet Gynecol. 2014; 57(4): 644-58.
  • Referans8.Kostova P, Zlatkov V. Clinical study on the effect of vaginal administration of micronized progesterone at dysfunctional uterinebleeding in premenopause. Akush Ginekol (Sofiia). 2009; 48(2): 3-7.
  • Referans9.Deligeoroglou E, Creatsas G. Menstrual disorders. Endocr Dev 2012; 22: 160-70.
  • Referans10.Hickey M, Higham JM, Fraser I. Progestogens with or without estrogen for irregular uterine bleeding associated with anovulation. Cochrane Database Syst Rev. 2012: 12; 9: CD001895.
  • Referans11.Paulson RJ, Collins MG, Yankov VI. Progesterone pharmacokinetics and pharmacodynamics with 3 dosages and 2 regimens of an effervescent micronized progesterone vaginal insert. J Clin Endocrinol Metab. 2014; 99(11): 4241-9.
  • Referans12.Africander D, Verhoog N, Hapgood JP. Molecular mechanisms of steroid receptor-mediated actions by synthetic progestins used in HRT and contraception. Steroids. 2011; 76(7): 636-52.
  • Referans13.Sitruk-Ware R. Pharmacology of different progestogens: the special case of drospirenone. Climacteric. 2005; 8(3): 4-12.
  • Referans14.Fujiwara T. A multi-center, randomized, open-label, parallel group study of a natural micronized progesteronevaginal tablet as a luteal support agent in Japanese women undergoing assisted reproductive technology. Reprod Med Biol 2015;14(4): 185-193.
  • Referans15.Coomarasamy A, Williams H, Truchanowicz E, Seed PT, Small R, Quenby S, et al. A Randomized Trial of Progesterone in Women with Recurrent MiscarriagesN Engl J Med 2015; 373(22): 2141-8.
  • Refarans16.Fernández-Murga L, Hermenegildo C, Tarín JJ, García-Pérez MÁ, Cano A. Endometrial response to concurrent treatment with vaginal progesterone and transdermal estradiol. Climacteric 2012;15(5): 455-9.
  • Referans17.Di Carlo C, Tommaselli GA, Gargano V, Savoia F, Bifulco G, Nappi C. Transdermal estradiol and oral or vaginal natural progesterone: bleeding patterns. Climacteric 2010; 13(5): 442-6.
  • Referans18.Nath A, Sitruk-Ware R. Different cardiovascular effects of progestins according to structure and activity. Climacteric 2009; 12(1): 96–101.
  • Referans19.Sitruk-Ware R, Nath A. Metabolic effects of contraceptive steroids. Rev Endocr Metab Disord 2011; 12(2): 63-75.
  • Referans20.Rafie S, Borgelt L, Koepf ER, Temple-Cooper ME, Lehman KJ. Novel oral contraceptive for heavy menstrual bleeding: estradiol valerate and dienogest. Int J Womens Health 2013; 5: 313-21.
  • Referans21.Spritzer PM, Vitola D, Vilodre LC, Wender MC, Reis FM, Ruschel S, et al.One year follow-up of hormone replacement therapy with percutaneous estradiol and low-dose vaginal natural progesterone in women with mild to moderate hypertension. Exp Clin Endocrinol Diabetes 2003; 111(5): 267–73.
  • Referans22.Bukowska H, Stanosz S, Zochowska E, Millo B, Sieja K, Chelstowski K, et al. Does the type of hormone replacement therapy affect lipoprotein (a), homocysteine, and C-reactive protein levels in postmenopausal women? Metabolism 2005;54(1): 72–8.
  • Referans23.Casanova G, Spritzer PM. Effects of micronized progesterone added to non-oral estradiol on lipids and cardiovascular risk factors in early postmenopause: a clinical trial. Lipids Health Dis 2012; 11: 133.
There are 23 citations in total.

Details

Primary Language English
Subjects Obstetrics and Gynaecology
Journal Section Research
Authors

Abdullah Tok 0000-0003-0998-5531

Gülcan Akdemir 0000-0002-0934-0226

Alev Özer 0000-0002-0934-0226

Gürkan Kıran

Publication Date March 31, 2021
Acceptance Date October 28, 2020
Published in Issue Year 2021 Volume: 46 Issue: 1

Cite

MLA Tok, Abdullah et al. “Micronised Vaginal Progesterone Versus Oral Dydrogestrone in the Treatment of Dysfunctional Uterine Bleeding: Efficacy and Effects on Lipid Profile”. Cukurova Medical Journal, vol. 46, no. 1, 2021, pp. 32-38.