Abstract
Purpose
Dienogest has recently been marketed as a medical treatment for endometriosis. Given the recent introduction on the market of Dienogest, little data are available regarding its effectiveness in routine clinical practice.
Methods
The study is an observational, single-center, cohort study. Eligible was women with a surgical diagnosis of endometriosis dating back <24 months or a clinical/instrumental diagnosis of endometriosis and endometriosis-associated pelvic pain score of at least 40 mm on a 100-mm visual analog scale (VAS) at start of treatment and who had been taking Dienogest 2 mg once daily treatment at the time of study entry for no more than 30 days, consecutively observed between September 2013 to September 2014. In accordance with routine practice, women came back for clinical assessment and evaluation of pain after 1 (V1), 3 (V2), and 12 (V3) months.
Results
A total of 132 women were enrolled in the study. A total of 21 of the enrolled patients were released from the study during follow-up due to adverse effects. The mean pelvic pain VAS score at baseline was 8.9 (SD 1.3). The corresponding values were 6.7 (SD 3.2) and 5.7 (SD 3.7) for dyspareunia and dyschezia. The mean VAS scores progressively and significantly decreased to 0.9 (SD 1.6) for pelvic pain, 1.4 (SD 2.1) for dyspareunia and 0.2 (SD 0.9) for dyschezia, respectively, 12 months after start of treatment.
Conclusion
This study confirms that in routine clinical practice, Dienogest 2 mg is an effective and well-tolerated treatment for endometriosis-related pain in women with endometriosis.
Similar content being viewed by others
References
Andres Mde P, Lopes LA, Baracat EC, Podgaec S (2015) Dienogest in the treatment of endometriosis: systematic review. Arch Gynecol Obstet 292:523–529
Doyle JO, Missmer SA, Laufer MR (2009) The effect of combined surgical-medical intervention on the progression of endometriosis in an adolescent and young adult population. J Pediatr Adolesc Gynecol 22:257–263
Exacoustos C, Malzoni M, Di Giovanni A, Lazzeri L, Tosti C, Petraglia F, Zupi E (2014) Ultrasound mapping system for the surgical management of deep infiltrating endometriosis. Fertil Steril 102(143–150):e142
Fawzy M, Mesbah Y (2015) Comparison of dienogest versus triptorelin acetate in premenopausal women with adenomyosis: a prospective clinical trial. Arch Gynecol Obstet 292:1267–1271
Friedl F, Riedl D, Fessler S, Wildt L, Walter M, Richter R, Schussler G, Bottcher B (2015) Impact of endometriosis on quality of life, anxiety, and depression: an Austrian perspective. Arch Gynecol Obstet 292:1393–1399
Harada T, Momoeda M, Taketani Y, Aso T, Fukunaga M, Hagino H, Terakawa N (2009) Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis–a randomized, double-blind, multicenter, controlled trial. Fertil Steril 91:675–681
Hudelist G, English J, Thomas AE, Tinelli A, Singer CF, Keckstein J (2011) Diagnostic accuracy of transvaginal ultrasound for non-invasive diagnosis of bowel endometriosis: systematic review and meta-analysis. Ultrasound Obstet Gynecol 37:257–263
Kohler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO (2010) A dose-ranging study to determine the efficacy and safety of 1, 2, and 4 mg of dienogest daily for endometriosis. Int J Gynaecol Obstet 108:21–25
Leyland N, Casper R, Laberge P, Singh SS, SOGC (2010) Endometriosis: diagnosis and management. J Obstet Gynaecol Can 32:S1–S32
Luciano DE, Luciano AA (2011) Management of endometriosis-related pain: an update. Womens Health (Lond) 7:585–590
Luisi S, Parazzini F, Angioni S, Arena S, Beretta P, Candiani M, Cela V, Fedele L, Litta P, Maiorana A, Nappi L, Porpora MG, Rosati M, Zullo F, Tosti C, Petraglia F (2015) Dienogest treatment improves quality of life in women with endometriosis. J Endometr Pelvic Pain Disord 7(4):124–128
Momoeda M, Harada T, Terakawa N, Aso T, Fukunaga M, Hagino H, Taketani Y (2009) Long-term use of dienogest for the treatment of endometriosis. J Obstet Gynaecol Res 35:1069–1076
Moore J, Copley S, Morris J, Lindsell D, Golding S, Kennedy S (2002) A systematic review of the accuracy of ultrasound in the diagnosis of endometriosis. Ultrasound Obstet Gynecol 20:630–634
Muzii L, di Tucci C, Achilli C, Benedetti Panici P (2015) Continuous versus cyclic oral contraceptives for endometriosis: any conclusive evidence? Arch Gynecol Obstet 292:477–478
Petraglia F, Hornung D, Seitz C, Faustmann T, Gerlinger C, Luisi S, Lazzeri L, Strowitzki T (2012) Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment. Arch Gynecol Obstet 285:167–173
Savelli L, Manuzzi L, Pollastri P, Mabrouk M, Seracchioli R, Venturoli S (2009) Diagnostic accuracy and potential limitations of transvaginal sonography for bladder endometriosis. Ultrasound Obstet Gynecol 34:595–600
Streuli I, de Ziegler D, Santulli P, Marcellin L, Borghese B, Batteux F, Chapron C (2013) An update on the pharmacological management of endometriosis. Expert Opin Pharmacother 14:291–305
Strowitzki T, Faustmann T, Gerlinger C, Seitz C (2010) Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol 151:193–198
Strowitzki T, Marr J, Gerlinger C, Faustmann T, Seitz C (2010) Dienogest is as effective as leuprolide acetate in treating the painful symptoms of endometriosis: a 24-week, randomized, multicentre, open-label trial. Hum Reprod 25:633–641
Troncon JK, Poli-Neto OB, Nogueira AA, Rosa ESJC (2015) Continuous or cyclic contraceptives for endometriosis: a question still without an answer. Arch Gynecol Obstet 292:481–482
Vercellini P, Pietropaolo G, De Giorgi O, Pasin R, Chiodini A, Crosignani PG (2005) Treatment of symptomatic rectovaginal endometriosis with an estrogen-progestogen combination versus low-dose norethindrone acetate. Fertil Steril 84:1375–1387
Vercellini P, Somigliana E, Consonni D, Frattaruolo MP, De Giorgi O, Fedele L (2012) Surgical versus medical treatment for endometriosis-associated severe deep dyspareunia: I. Effect on pain during intercourse and patient satisfaction. Hum Reprod 27:3450–3459
Vercellini P, Bracco B, Mosconi P, Roberto A, Alberico D, Dhouha D, Somigliana E (2016) Norethindrone acetate or dienogest for the treatment of symptomatic endometriosis: a before and after study. Fertil Steril 105(734–743):e733
Zorbas KA, Economopoulos KP, Vlahos NF (2015) Continuous versus cyclic oral contraceptives for the treatment of endometriosis: a systematic review. Arch Gynecol Obstet 292:37–43
Petraglia F, Hornung D, Seitz C, Faustmann T, Gerlinger C, Luisi S, Lazzeri L, Strowitzki T (2012) Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment. Arch Gynecol Obstet 285(1):167–173. doi:10.1007/s00404-011-1941-7 (epub 2011 Jun 17)
Fawzy Mesbah (2015) Comparison of dienogest versus triptorelin acetate in premenopausal women with adenomyosis: a prospective clinical trial. Arch Gynecol Obstet 292(6):1267–1271. doi:10.1007/s00404-015-3755-5 (Epub 2015 May 20)
Author information
Authors and Affiliations
Contributions
AM: project development. DI: data collection or management and manuscript writing/editing. FP: data analysis. WA: manuscript writing/editing. AM: manuscript writing/editing. LG: manuscript writing/editing. LA: project development.
Corresponding author
Ethics declarations
Conflict of interest
FP received fee by Bayer SpA for participation to Editorial Board. The other authors declare that they are no conflict of interest. All authors have full control of all primary data and that they agree to allow the Journal to review their data if requested.
Ethical approval
This article does not contain any studies with human participants or animals performed by any of the authors.
Rights and permissions
About this article
Cite this article
Maiorana, A., Incandela, D., Parazzini, F. et al. Efficacy of dienogest in improving pain in women with endometriosis: a 12-month single-center experience. Arch Gynecol Obstet 296, 429–433 (2017). https://doi.org/10.1007/s00404-017-4442-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00404-017-4442-5