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INTRODUCTION: This study was designed to evaluate the feasibility and effectiveness of hysteroscopy in the management of symptoms related to endometrial polyps and submucous leiomyomas in women using a levonorgestrel-releasing intrauterine system (LNG-IUS). MATERIAL AND METHODS: Twenty-three LNG-IUS users presenting with endometrial polyps and/or submucous leiomyomas and irregular uterine bleeding were recruited for hysteroscopic examination and surgery. Intrauterine pathology was investigated and treated by hysteroscopic resection with the LNG-IUS in situ, and the effect of the procedure on symptoms was evaluated after three to six months. RESULTS: Intrauterine pathology was successfully resected by hysteroscopy in 23 (100.0%) out of 23 cases. Following hysteroscopy, 18 (78.3%) women reported amenorrhea, one (4.3%) regular spotting, three (13.0%) irregular spotting and one (4.3%) patient resumed normal menstrual cycle. We conclude that 19 (82.6%) patients were postoperatively asymptomatic. All procedures were uncomplicated and 4 (17.4%) were carried out without general anesthesia as office procedures. CONCLUSION: Endometrial polyps and submucous leiomyomas can develop in LNG-IUS users, and this can cause irregular uterine bleeding. Hysteroscopic resection of these pathologies is a feasible method in the clinical management of symptoms.

MeSH
děložní krvácení MeSH
leiomyom * farmakoterapie chirurgie MeSH
levonorgestrel terapeutické užití MeSH
lidé MeSH
nádory dělohy * farmakoterapie chirurgie MeSH
nitroděložní tělíska hormonální * MeSH
polypy * farmakoterapie chirurgie MeSH
Check Tag
lidé MeSH
ženské pohlaví MeSH
Publikační typ
časopisecké články MeSH

Článek

Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2

European journal of obstetrics, gynecology and reproductive biology. 2020 ; 252 (-) : 7-14. [pub] 20200531

Eur J Obstet Gynecol Reprod Biol
ISSN 1872-7654
Medvik
Zdroj

OBJECTIVE: To assess the efficacy of vilaprisan compared with placebo in the management of the symptoms of uterine fibroids (UF), with a secondary objective to provide a descriptive comparison with ulipristal acetate. STUDY DESIGN: The randomized, parallel-group, double-blind, placebo- and active-controlled, multicenter ASTEROID 2 trial assessed the efficacy and safety of vilaprisan versus placebo and ulipristal acetate for two 12-week treatment periods in women with ≥1 UF experiencing heavy menstrual bleeding (HMB). The primary endpoint compared the efficacy of vilaprisan with placebo at 12 weeks, assessed as the absence of bleeding/spotting by bleeding diary. Secondary endpoints compared the efficacy of vilaprisan with ulipristal acetate. Results of the first 12-week treatment period are reported here. RESULTS: Women (mean age 42.5 years) were enrolled from 1 June 2015. At baseline, mean menstrual blood loss per 28 days was 214.1 mL and the volume of the three largest UF was 106.2 mL. In total, 155 women completed the initial 12-week treatment period. Complete absence of bleeding/spotting until the end of the 12-week treatment period was achieved by 62.9 % of women receiving vilaprisan versus 0.0 % with placebo (p < .001); 55.4 % of women treated with ulipristal acetate reported absence of bleeding/spotting. The predefined HMB response (<80 mL and >50 % reduction from baseline during the last 28 days of treatment) was observed in 95.7 % of subjects treated with vilaprisan and 86.5 % of subjects treated with ulipristal acetate. Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group. No safety concerns, including multiple laboratory parameters, were identified. CONCLUSION: Daily administration of vilaprisan 2 mg induced amenorrhea, controlled bleeding, decreased UF size, and was well tolerated in women with HMB associated with UF. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number: NCT02465814 https://clinicaltrials.gov/ct2/show/NCT02465814.