The levonorgestrel‐releasing intrauterine system is associated with a reduction in dysmenorrhoea and dyspareunia, a decrease in <scp>CA</scp> 125 levels, and an increase in quality of life in women with suspected endometriosis

Purpose The aim of this prospective study was to evaluate quality of life (QoL) and sexual function of women affected by endometriosis pain treated with Dienogest (DNG) for 24 months. Patients and methods Fifty-four women constituted the study group and were given DNG 2 mg/daily; 38 women were given non-steroidal anti-inflammatory drugs (NSAIDs) and constituted the control group. To define endometriosis-associated pelvic pain, dysmenorrhea and dyspareunia the Visual Analogic Scale (VAS) was used. The Short Form-36 (SF-36), the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS) were used to assess the QoL, sexual function and the sexual distress, respectively. The study included five follow-ups at 3, 6, 12, 18 and 24 months. Results Slight improvements in chronic pelvic pain, dysmenorrhea and dyspareunia were observed in the study group at 3 months ( p <0.05) and improved more from 6 to 24 months of DNG treatment ( p <0.001). QoL improved with a similar trend: at 3 months the improvement was significant in several categories ( p <0.05), and from 6 to 24 months in all categories ( p <0.001). The FSFI score did not change at the 3 month follow-up ( p =not significant [NS]) but it improved from 6 to 24 months ( p <0.001). A similar trend was observed for the FSDS score ( p <0.001). No change was observed in the control group ( p =NS). Conclusion Long-term treatment with DNG 2 mg once-daily in women with endometriosis-associated pelvic pain may have positive effects on the QoL and sexual life, confirming the observations of the previous study on the first 6 months of treatment.

Section: Introductionmentioning

confidence: 99%

<p>Effects of long-term treatment with Dienogest on the quality of life and sexual function of women affected by endometriosis-associated pelvic pain</p>

Caruso¹,

Iraci²,

Cianci³

et al. 2019

JPR

“…Previously Vercellini et al [24] had published a pilot study using LNG-IUD versus expectant management after CS for symptomatic endometriosis with signi cant reduction of dysmenorrhea and risk of recurrence. Subsequently, other studies [9,[25][26][27][28][29][30][31][32] have also shown that LNG-IUD is an effective and well accepted treatment to reduce dyspareunia and dysmenorrhea and increase quality of life in women with suspected endometriosis. However, the long-term maintenance therapy using LNG-IUD after surgery was not effective for preventing endometrioma recurrence [30].…”

Section: Discussionmentioning

confidence: 99%

Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

Velasco

2020

Preprint

Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences.Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019).Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time.Details of trial registration: Eudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

“…Previously Vercellini et al [32] had published a pilot study using LNG-IUD versus expectant management after CS for symptomatic endometriosis with signi cant reduction of dysmenorrhea and risk of recurrence. Subsequently, other studies [9,[33][34][35][36][37][38][39][40] have also shown that LNG-IUD is an effective and well accepted treatment to reduce dyspareunia and dysmenorrhea and increase quality of life in women with suspected endometriosis. However, the longterm maintenance therapy using LNG-IUD after surgery was not effective for preventing endometrioma recurrence [38].…”

Section: Discussionmentioning

confidence: 99%

Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

Velasco

2020

Preprint

Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.