Pleasant Grove

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 evaluating the effects of MELT-300 on procedural sedation in adults undergoing cataract extraction with lens replacement CELR. This Phase 3 clinical trial aims to compare MELT-300 with a placebo and an active comparator, sublingual midazolam, to assess the contribution of ketamine in the combined drug product. The study focuses on the effectiveness and safety of MELT-300 during and after cataract surgery. Participants will be randomly assigned to one of three groups MELT-300 a sublingual tablet containing 3 mg midazolam and 50 mg ketamine, midazolam alone 3 mg sublingual tablet, or a placebo tablet. They will receive a single dose of the assigned medication approximately 30 minutes before surgery without food or water. The surgery will be performed under topical anesthesia, and the study medication effects will be assessed before, during, and after the procedure. Participants will be admitted on the day of surgery and monitored throughout. Researchers will assess sedation levels, the need for additional sedation or pain medication, and the ability to complete surgery. Safety will be tracked through adverse event monitoring, vital signs, and physical exams at baseline, during surgery, and up to three days after medication. The primary outcome measured is the percentage of participants achieving successful procedural sedation at various time points on the day of surgery.

Researchers are evaluating whether the InTune product system can support attention, memory, focus, and other thinking skills in healthy adults aged 18 to 64. The study is designed as a double-blind, placebo-controlled, parallel, adaptive trial to rigorously assess this essential oil-based cognitive support system alongside cognitive training. This research addresses the need for well-controlled trials in a younger, actively performing population, as cognitive performance in this age group directly affects academic success, workplace productivity, and daily functioning. Participants will be randomly assigned to receive either the InTune products or placebo products that look and feel the same but lack active ingredients. The InTune system includes aromatic use of a nasal aroma stick containing a proprietary essential oil blend and topical application of a solid stick with 25% InTune essential oil blend plus additional botanical extracts. The placebo group uses similar aroma and topical sticks without the active essential oils. Aromatic use involves breathing from the aroma stick during cognitive testing, and topical use involves applying the stick before daily cognitive training. Participants will complete cognitive tests and questionnaires at the start and end of the study, including measures of memory performance, mental clarity, focus, and other cognitive scales. Researchers will monitor product experiences and any side effects. The primary outcome is a composite z-score assessed during a single 90-minute study visit. Secondary measures include patient-reported cognitive scales, visual analog scales for mental clarity and focus, and adverse events. Participation involves one study visit and daily use of the assigned products throughout the trial, with the study expected to complete by August 2026.

Researchers are evaluating the safety and effectiveness of Fertilo compared to Medicult IVM for in vitro maturation IVM of eggs in women aged 18 to 35. The study aims to determine if Fertilo leads to more ongoing pregnancies at 12 weeks gestation than the currently approved Medicult IVM system. This is a phase III randomized control trial sponsored by Gameto, Inc.