West New York

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

This research aims to explore the relationship between donor-derived cell-free DNA (DD-cfDNA) levels and human leukocyte antigen (HLA) antibodies in blood samples from heart transplant recipients. It also evaluates the Molecular Microscope4 Diagnostic System (MMDx) results from both indication and protocol biopsies to better understand heart transplant rejection. The study addresses limitations of the current standard, endomyocardial biopsy interpreted by histology, which can have high error rates due to variability among pathologists. The goal is to improve precision and accuracy in detecting rejection and injury in heart transplants. The study involves three diagnostic tests: the MMDx microarray test which analyzes gene expression in heart biopsies, the Prospera test that measures DD-cfDNA in patient blood using advanced sequencing technology, and a centralized measurement of HLA antibodies in blood. Researchers will collect 300 new biopsies and corresponding blood samples to compare DD-cfDNA levels with MMDx biopsy diagnoses of T cell-mediated rejection, antibody-mediated rejection, and tissue injury. HLA antibodies will also be assessed centrally to identify donor-specific antibodies. Participants will undergo biopsies and blood draws as part of their standard care, with samples analyzed using the three diagnostic methods. Researchers will measure and calibrate the DD-cfDNA test results against MMDx findings and HLA antibody data over periods up to 18 months. The study will report calibrated results for rejection and heart injury at 6 and 18 months, aiming to enhance transplant rejection monitoring. This study is an extension of a previous clinical trial and involves prospective collection of clinical and protocol biopsy samples.