Kristof Chwalisż

ORCID: 0000-0002-0833-0114 · 47 papers in corpus
review 2023
Clinical development of the GnRH agonist leuprolide acetate depot
F&S reports ·doi:10.1016/j.xfre.2022.11.011

Leuprolide acetate is the first GnRH agonist that entered clinical development after the discovery of the native GnRH. Several long-acting depot formulations of leuprolide acetate (ranging from 1-month to 6-month intramuscular injections) h…

review 2023
Clinical development of the oral gonadotropin-releasing hormone antagonist elagolix
F&S reports ·doi:10.1016/j.xfre.2023.02.002

Elagolix is the first oral gonadotropin-releasing hormone antagonist that entered clinical development and received regulatory approval for the management of women with endometriosis and heavy menstrual bleeding associated with uterine fibr…

review 2019
Clinical evaluation of the oral gonadotropin-releasing hormone-antagonist elagolix for the management of endometriosis-associated pain
Pain management ·doi:10.2217/pmt-2019-0010

Endometriosis is an estrogen-dependent chronic inflammatory disease associated with pelvic pain symptoms that are often severe, mainly dysmenorrhea, nonmenstrual pelvic pain and dyspareunia. This condition is also associated with peripheral…

rct 2019
Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory Women
The Journal of clinical endocrinology and metabolism ·doi:10.1210/clinem/dgz086

CONTEXT: Elagolix is an oral gonadotropin-releasing hormone (GnRH) antagonist recently approved for the treatment of endometriosis-associated pain and being developed for heavy menstrual bleeding associated with uterine fibroids. OBJECTIVE…

other 2018
Development and Validation of the Endometriosis Daily Pain Impact Diary Items to Assess Dysmenorrhea and Nonmenstrual Pelvic Pain
Reproductive sciences (Thousand Oaks, Calif.) ·doi:10.1177/1933719118789509

Daily diary-based dysmenorrhea and nonmenstrual pelvic pain impact items were developed and validated to measure efficacy in endometriosis clinical trial settings. Items were developed across 3 stages of qualitative research, and their psyc…

2018
Efficacy and safety of elagolix in a subgroup of women with uterine fibroids and adenomyosis: results from a phase 2 trial
·doi:10.1016/j.fertnstert.2018.07.186
2018
Efficacy and Safety of Elagolix in a Subgroup of Women with Uterine Fibroids and Adenomyosis: Results from a Phase 2 Trial
·doi:10.1016/j.jmig.2018.09.175
2018
Estradiol Levels are Differentially Suppressed by Elagolix Compared to Leuprolide Acetate
·doi:10.1016/j.jmig.2018.09.090
2018
Long-term Effect of Elagolix on Bone Mineral Density in Women with Endometriosis-Associated Pain [38G]
·doi:10.1097/01.aog.0000533387.12236.72

INTRODUCTION: To evaluate the long-term effect of elagolix, an oral, non-peptide GnRH antagonist, on bone mineral density (BMD) in two 6-month (M) extension studies (Elaris EM-III and IV) of the pivotal, 6M, phase 3 studies (12M overall tre…

rct 2018
Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies
Obstetrics and gynecology ·doi:10.1097/aog.0000000000002675

OBJECTIVE: To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain. METHODS: Elaris Endometriosis (EM)-III and -IV were exte…

2018
Long-Term Safety and Efficacy of Elagolix Treatment in Women With Endometriosis-Associated Pain [11OP]
·doi:10.1097/01.aog.0000533299.54528.7c

INTRODUCTION: Long-term safety and efficacy of elagolix, an oral, non-peptide GnRH antagonist for the management of endometriosis-associated pain, was evaluated in two 6-month (M) extension studies (Elaris EM-III and IV) of the pivotal, 6M,…

2018
Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist
·doi:10.1530/ey.15.15.6

We highlight this paper for 3 reasons. First, remarkably there are few robust data on effective treatment options for endometriosis. Subcutaneous GnRH antagonists are sometimes used off-label, but with very limited evidence. Secondly, the c…

2017
Long-term effect of elagolix on bone mineral density: results from two phase 3 extension studies in women with endometriosis-associated pain
·doi:10.1016/j.fertnstert.2017.07.292
2017
Long-term effect of elagolix on the endometrium: results from two phase 3 extension studies in women with endometriosis-associated pain
·doi:10.1016/j.fertnstert.2017.07.147
2017
Long-Term Effect of Elagolix on the Endometrium: Results from Two Phase 3 Extension Studies in Women with Endometriosis-Associated Pain
·doi:10.1016/j.jmig.2017.08.051
2017
Long-term safety and efficacy of elagolix treatment in women with endometriosis-associated pain: primary results from two phase 3 extension studies
·doi:10.1016/j.fertnstert.2017.07.293
2017
Long-Term Safety and Efficacy of Elagolix Treatment in Women with Endometriosis-Associated Pain: Primary Results From Two Phase 3 Extension Studies
·doi:10.1016/j.jmig.2017.08.078
2017
Maintenance of endometriosis-associated pain reduction and quality of life improvement in phase 3 extension studies with elagolix
·doi:10.1016/j.fertnstert.2017.07.294
2017
O-GYN-MD-126 Primary Efficacy and Safety Results from Two Double-Blind, Randomized, Placebo-Controlled Studies Of Elagolix, an Oral Gonadotropin-Releasing Hormone Antagonist, in Women With Endometriosis-Associated Pain
·doi:10.1016/j.jogc.2017.03.067
rct 2017
Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist
·doi:10.1056/nejmoa1700089

Copyright © 2017 Massachusetts Medical Society. BACKGROUND Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, …

2016
Elagolix, an oral gonadotropin-releasing hormone antagonist, for the management of endometriosis-associated pain: safety and efficacy results from two double-blind, randomized, placebo-controlled studies
·doi:10.1016/j.fertnstert.2016.07.780
2016
The effect of elagolix on the endometrium: safety results from two randomized, placebo-controlled studies in women with endometriosis-associated pain
·doi:10.1016/j.fertnstert.2016.07.274
2016
The impact of elagolix on quality of life in women with endometriosis-associated pain: results from two randomized, placebo-controlled studies using the endometriosis health profile questionnaire
·doi:10.1016/j.fertnstert.2016.07.271
2016
Use of elagolix for the management of endometriosis-associated pain: secondary efficacy results from two randomized, placebo-controlled studies
·doi:10.1016/j.fertnstert.2016.07.774
rct 2015
Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist: Results from a Phase 2, Randomized Controlled Study
·doi:10.5301/je.5000211

Purpose Elagolix is a novel, oral GnRH antagonist that dose-dependently suppresses estradiol levels. This study evaluated safety and efficacy of elagolix vs. leuprorelin acetate (LA) and placebo in women with endometriosis-associated pain. …