West New York

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months 4 years, followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry DXA. Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are investigating the relationship between donor-derived cell-free DNA DD-cfDNA levels, HLA antibodies in blood, and results from the Molecular Microscope Diagnostic System MMDx in heart transplant recipients. The study aims to improve accuracy in detecting rejection by comparing the new DD-cfDNA blood test Prospera with the MMDx microarray test and central HLA antibody measurements. This observational study builds on previous work and addresses the challenge of variability in traditional biopsy interpretations. Participants include heart transplant patients undergoing biopsies either for clinical reasons or as part of routine protocol monitoring, especially in high-risk cases. The study collects blood samples at the time of biopsies to measure DD-cfDNA and HLA antibodies, while biopsies are analyzed using the MMDx system. The study plans to include 300 additional biopsies and corresponding blood samples to calibrate the Prospera test against MMDx diagnoses of different types of rejection and tissue injury. During the study, participants will have biopsies and blood samples collected as part of their regular care. Researchers will analyze gene expression from biopsies and measure DD-cfDNA and HLA antibodies in blood samples. The primary outcomes involve calibrating the Prospera test for different rejection types and heart injury over 18 months. Secondary outcomes assess whether the blood test could replace biopsies. Safety and antibody status will also be monitored, with the study continuing through 2028.