Comparing Levonorgestrel-releasing intrauterine system (Mirena) and medroxyprogesterone acetate as a therapy for endometrial hyperplasia

Abstract

Background: This study was designed to evaluate the comparison of insertion of levonorgestrel (LNG)-releasing intrauterine system versus oral medroxyprogesterone acetate on endometrial hyperplasia in a randomized controlled trial. Materials and Methods: A total of 60 women with the initial histopathological diagnosis of endometrial hyperplasia in two groups received LNG or medroxyprogesterone (10 mg/d orally) for 12 days a month for 3 months). Endometrial biopsy was obtained for all patients after 3 months of treatment. Response to treatment was defined based on the histopathology of the post treatment pipelle endometrial specimens in three categories of resolution, persistence and progression. Results: Treatment response rate in patients in the LNG group was 89.3% (25 of 28 patients), versus 70.4% (19 of 27 patients) in patients in the medroxyprogesterone group. The rate of persistence was 10.7% (3 of 28 patients) and 22.2% (6 of 27 patients) in LNG and medroxyprogesterone groups respectively. No progression of endometrial hyperplasia observed in any of the patients in LNG group, but progression of endometrial hyperplasia was observed in 7.4% (2 of 27 patients) in the medroxyprogesterone group. There was no statistically significant difference between groups regarding the response to treatment ( P = 0.15). Side effects such as bloating, weight gain, fatigue and hair loss were comparable between the groups ( P > 0.05). Hirsutism was significantly more in the medroxyprogesterone group than LNG group ( P = 0.013). Conclusion: Results showed that the use of LNG for treating endometrial hyperplasia for 3 months was associated with high-treatment response rate and the low proportion of patients with progression compared to the use of medroxyprogesterone.

Baseline Serum HE4 But Not Tissue HE4 Expression Predicts Response to the Levonorgestrel-Releasing Intrauterine System in Atypical Hyperplasia and Early Stage Endometrial Cancer

“…The strengths of this study are that the design was prospective, and patients were selected consecutively, which minimised bias. In addition, 68% of AH/Stage Ia EEC patients responded to the LNG-IUS by 12 months, with AH showing a higher response rate compared to Stage I EEC, similar to previous studies [7][8][9][10][11] supporting that the sample is representative of the background patient population. Baseline serum HE4 was also positively associated with patient age, BMI, menopause, in agreement with previous studies [17,18,[22][23][24]30,31].…”

“…Studies have shown that oral progestogens can reverse AH and Stage Ia EEC in 70-75% patients by 12 months [2][3][4][5][6]. Further studies have shown that the levonorgestrel-releasing intrauterine system (LNG-IUS) produces fewer systemic side effects and regression rates of 84-100% in AH [7][8][9][10][11] and 68% in stage I EEC [12]. This has led to increased use of the LNG-IUS compared to oral progestogens as a conservative therapy.…”

Progestin Intrauterine Devices and Metformin: Endometrial Hyperplasia and Early Stage Endometrial Cancer Medical Management

“…A RCT of 60 participants in total, compared EH treatment with the 52 mg-IUD/10–20 mcg-LNG-14t to MPA 10 mg orally daily for 12 days monthly for 3-months [ 20 ]. The 52 mg-IUD/10–20 mcg-LNG-14t achieved an 89.3% regression rate without any cases of disease progression, whereas cyclic MPA had a 70.4% regression rate with 7.4% disease progression [ 20 ].…”

“…A RCT of 60 participants in total, compared EH treatment with the 52 mg-IUD/10–20 mcg-LNG-14t to MPA 10 mg orally daily for 12 days monthly for 3-months [ 20 ]. The 52 mg-IUD/10–20 mcg-LNG-14t achieved an 89.3% regression rate without any cases of disease progression, whereas cyclic MPA had a 70.4% regression rate with 7.4% disease progression [ 20 ]. While hirsutism occurred significantly more often in the MPA group, p = 0.013, this study, which did not use intent to treat analysis, was underpowered for the 18.9 percentage-point regression rate difference to achieve statistically significance [ 20 ].…”

“…Oral and depo progestin administration can reduce tamoxifen's efficacy without preventing endometrial polyps, endometrial cyst, and leiomyoma formation [ 23 ]. Oral and depo progestin administration are associated with systemic adverse effects: Acne, cyclic breast symptoms, deep venous thrombosis, edema, fatigue, gastrointestinal symptoms including altered appetite and nausea, hirsutism, irritability, sleep dysfunction, and weight gain [ 12 , 18 , 20 , 21 , 23 ]. High doses of megestrol acetate (80 to 400 mg) or MPA (500 to 1000 mg) achieve endometrial response but have adherence reducing increased adverse effects [ 17 ].…”