Shebley M

No ORCID on file · 10 papers in corpus · active 2020-2024

Study types

  • article 2
  • other 2
  • rct 1
  • review 1

Condition tags

  • endometriosis 5
rct 2024
Bioequivalence of Elagolix/Estradiol/Norethindrone Acetate Fixed-Dose Combination Product: Phase 1 Results in Healthy Pre- and Postmenopausal Women
Clinical pharmacology in drug development ·doi:10.1002/cpdd.1399

Fixed-dose combination (FDC) therapies can enhance patient convenience and adherence to prescribed treatment regimens. Elagolix is a novel oral gonadotropin-releasing hormone receptor antagonist approved for management of moderate to severe…

2023
Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome.
F&S reports ·doi:10.1016/j.xfre.2023.02.007

ObjectiveEvaluate the efficacy and safety of elagolix, a GnRH antagonist, to treat polycystic ovarian syndrome (PCOS).DesignA phase 2, multicenter, double-blind, randomized, placebo-controlled trial.SettingOutpatient and academic medical ce…

other 2023
Virtual Bioequivalence Assessment of Elagolix Formulations Using Physiologically Based Pharmacokinetic Modeling
The AAPS journal ·doi:10.1208/s12248-023-00794-6

In lieu of large bioequivalence studies and exposing healthy postmenopausal women to additional drug exposure for elagolix coadministered with hormonal add-back therapy, physiologically based pharmacokinetic (PBPK) modeling was used with in…

2022
Effects of elagolix on the pharmacokinetics of omeprazole and its metabolites in healthy premenopausal women.
Clinical and translational science ·doi:10.1111/cts.13247

This study evaluated the effect of repeated doses of elagolix on the pharmacokinetics (PK) of omeprazole and its metabolites in healthy premenopausal female subjects. Adult premenopausal female subjects (N = 20) received a single oral dose …

2022
Physiologically based pharmacokinetic modeling and simulations to inform dissolution specifications and clinical relevance of release rates on elagolix exposure.
Biopharmaceutics & drug disposition ·doi:10.1002/bdd.2315

The aim of this analysis was to use a physiologically based pharmacokinetic (PBPK) model to predict the impact of changes in dissolution rates on elagolix exposures and define clinically relevant acceptance criteria for dissolution. Varying…

other 2021
A Personalized Medicine Approach Using Clinical Utility Index and Exposure-Response Modeling Informed by Patient Preferences Data
CPT: pharmacometrics & systems pharmacology ·doi:10.1002/psp4.12570

Selection of a personalized dose for an individual patient can be informed by the patient's preferences, translated as weights on each of the clinically relevant safety and efficacy drug attributes, based on results from a brief patient pre…

review 2021
Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life
Journal of women's health (2002) ·doi:10.1089/jwh.2020.8989

Bone mineral density (BMD) changes during the life span, increasing rapidly during adolescence, plateauing in the third decade of life, and subsequently entering a phase of age-related decline. In women, menopause leads to accelerated bone …

2021
Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women.
Clinical and translational science ·doi:10.1111/cts.13006

Decline of bone mineral density (BMD) during menopause is related to increased risk of fractures in postmenopausal women, however, this relationship in premenopausal women has not been established. To quantify this relationship, real-world …

article 2021
Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis
Clinical and translational science ·doi:10.1111/cts.13040

Abstract Elagolix is a novel, oral gonadotropin‐releasing hormone receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis and heavy menstrual bleeding associated with uterine fibroids. Consi…

article 2020
Drug–Drug Interaction Studies of Elagolix with Oral and Transdermal Low-Dose Hormonal Add-Back Therapy
Clinical pharmacokinetics ·doi:10.1007/s40262-020-00921-y

Background and objectiveElagolix is an oral, non-peptide, gonadotropin-releasing hormone receptor antagonist. It is approved for the treatment of moderate-to-severe pain associated with endometriosis and is being investigated for the treatm…