Skip to main content
Top
Published in: Archives of Gynecology and Obstetrics 4/2018

01-10-2018 | General Gynecology

Long-term treatment of endometriosis with dienogest: retrospective analysis of efficacy and safety in clinical practice

Author: Thomas Römer

Published in: Archives of Gynecology and Obstetrics | Issue 4/2018

Login to get access

Abstract

Purpose

Endometriosis is a debilitating disease with high recurrence rates requiring long-term management. Progestins such as dienogest are used empirically when first symptoms occur and post-surgery to reduce recurrence. This retrospective, practice-based study assessed the efficacy and safety of dienogest in women with endometriosis treated for at least 60 months.

Methods

37 women (age 39 ± 8 years) with laparoscopically diagnosed endometriosis received dienogest 2 mg orally once daily. Endometriosis-associated pelvic pain (EAPP) was measured on a 0–100 mm visual analog scale at baseline and every 12 months. Laboratory measures of lipid and liver metabolism, hemostatic and hormonal parameters were investigated in a subgroup of 15 women. Adverse events including bleeding disturbances and depressive symptoms were recorded.

Results

In 22 women, dienogest was begun after laparoscopy; median EAPP score was 70 mm pre-surgery and 10, 10, 20, 20, and 20 mm, respectively, after 12, 24, 36, 48, and 60 months of dienogest treatment. Another 15 women began dienogest without prior surgery; median EAPP score was 80 mm pretreatment and 20, 20, 30, 30, and 30 mm, respectively, after 12, 24, 36, 48, and 60 months. All laboratory parameters remained within the normal range. Mean serum estradiol was 28 ± 12 pg/ml after 60 months. Seven women experienced spotting episodes and four women presented with phases of depressed mood, which could all be clinically managed.

Conclusions

Long-term (60-month) treatment with dienogest 2 mg once-daily in women with endometriosis effectively reduced EAPP and avoided pain recurrence post-surgery. Dienogest was well tolerated and adverse effects were clinically managed.
Literature
1.
go back to reference Koninckx PR, Meuleman C, Demeyere S, Lesaffre E, Cornillie FJ (1991) Suggestive evidence that pelvic endometriosis is a progressive disease, whereas deeply infiltrating endometriosis is associated with pelvic pain. Fertil Steril 55(4):759–765CrossRef Koninckx PR, Meuleman C, Demeyere S, Lesaffre E, Cornillie FJ (1991) Suggestive evidence that pelvic endometriosis is a progressive disease, whereas deeply infiltrating endometriosis is associated with pelvic pain. Fertil Steril 55(4):759–765CrossRef
5.
go back to reference Dunselman GA, Vermeulen N, Becker C, Calhaz-Jorge C, D’Hooghe T, De Bie B, Heikinheimo O, Horne AW, Kiesel L, Nap A, Prentice A, Saridogan E, Soriano D, Nelen W, European Society of Human Reproduction and Embryology (2014) ESHRE guideline: management of women with endometriosis. Hum Reprod 29(3):400–412. https://doi.org/10.1093/humrep/det457 CrossRefPubMed Dunselman GA, Vermeulen N, Becker C, Calhaz-Jorge C, D’Hooghe T, De Bie B, Heikinheimo O, Horne AW, Kiesel L, Nap A, Prentice A, Saridogan E, Soriano D, Nelen W, European Society of Human Reproduction and Embryology (2014) ESHRE guideline: management of women with endometriosis. Hum Reprod 29(3):400–412. https://​doi.​org/​10.​1093/​humrep/​det457 CrossRefPubMed
9.
go back to reference Leyland N, Casper R, Laberge P, Singh SS, SOCG (2010) Endometriosis: diagnosis and management. J Obstet Gynaecol Can 32(7 Suppl 2):S1–S32CrossRef Leyland N, Casper R, Laberge P, Singh SS, SOCG (2010) Endometriosis: diagnosis and management. J Obstet Gynaecol Can 32(7 Suppl 2):S1–S32CrossRef
15.
go back to reference Katsuki Y, Takano Y, Futamura Y, Shibutani Y, Aoki D, Udagawa Y, Nozawa S (1998) Effects of dienogest, a synthetic steroid, on experimental endometriosis in rats. Eur J Endocrinol 138(2):216–226CrossRef Katsuki Y, Takano Y, Futamura Y, Shibutani Y, Aoki D, Udagawa Y, Nozawa S (1998) Effects of dienogest, a synthetic steroid, on experimental endometriosis in rats. Eur J Endocrinol 138(2):216–226CrossRef
34.
37.
go back to reference Revised American society for reproductive medicine classification of endometriosis: 1996 (1997). Fertil Steril 67(5):817–821 Revised American society for reproductive medicine classification of endometriosis: 1996 (1997). Fertil Steril 67(5):817–821
39.
go back to reference Lang J, Zhang X, Zhou Y, Di W, Gude K, Dong L (2017) Efficacy and safety of dienogest in Chinese women with endometriosis: a 24-week, multicenter, randomized, placebo-controlled study with 28-week open-label phase. Presented at the 13th World Congress on Endometriosis, Vancouver, Canada, 17–20 May 2017 Lang J, Zhang X, Zhou Y, Di W, Gude K, Dong L (2017) Efficacy and safety of dienogest in Chinese women with endometriosis: a 24-week, multicenter, randomized, placebo-controlled study with 28-week open-label phase. Presented at the 13th World Congress on Endometriosis, Vancouver, Canada, 17–20 May 2017
41.
go back to reference Vercellini P, Fedele L, Pietropaolo G, Frontino G, Somigliana E, Crosignani PG (2003) Progestogens for endometriosis: forward to the past. Hum Reprod Update 9(4):387–396CrossRef Vercellini P, Fedele L, Pietropaolo G, Frontino G, Somigliana E, Crosignani PG (2003) Progestogens for endometriosis: forward to the past. Hum Reprod Update 9(4):387–396CrossRef
43.
go back to reference Lorencatto C, Petta CA, Navarro MJ, Bahamondes L, Matos A (2006) Depression in women with endometriosis with and without chronic pelvic pain. Acta Obstet Gynecol Scand 85(1):88–92CrossRef Lorencatto C, Petta CA, Navarro MJ, Bahamondes L, Matos A (2006) Depression in women with endometriosis with and without chronic pelvic pain. Acta Obstet Gynecol Scand 85(1):88–92CrossRef
46.
go back to reference Barbieri RL (1992) Hormone treatment of endometriosis: the estrogen threshold hypothesis. Am J Obstet Gynecol 166(2):740–745CrossRef Barbieri RL (1992) Hormone treatment of endometriosis: the estrogen threshold hypothesis. Am J Obstet Gynecol 166(2):740–745CrossRef
Metadata
Title
Long-term treatment of endometriosis with dienogest: retrospective analysis of efficacy and safety in clinical practice
Author
Thomas Römer
Publication date
01-10-2018
Publisher
Springer Berlin Heidelberg
Published in
Archives of Gynecology and Obstetrics / Issue 4/2018
Print ISSN: 0932-0067
Electronic ISSN: 1432-0711
DOI
https://doi.org/10.1007/s00404-018-4864-8

Other articles of this Issue 4/2018

Archives of Gynecology and Obstetrics 4/2018 Go to the issue