Pleasant Grove

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.

Researchers are evaluating the efficacy and safety of MELT-300, a sublingual tablet containing midazolam and ketamine, for procedural sedation in adults undergoing cataract extraction with lens replacement (CELR). This Phase 3, randomized, double-masked, placebo-controlled study includes an active comparator, sublingual midazolam, to assess the contribution of ketamine in MELT-300. The study aims to compare MELT-300 with placebo and midazolam to understand sedation effectiveness, time to sedation, and safety concerns during cataract surgery. Participants will be randomly assigned to one of three groups: MELT-300, midazolam alone, or placebo. Each participant will receive one sublingual tablet 30 (±5) minutes before surgery, without food or water, just prior to the administration of topical ocular anesthetic gel. The study involves a single day of treatment and surgery, with sedation evaluated before, during, and at the end of the surgery. Participants will be admitted on Day 1 for surgery and medication administration. Researchers will monitor sedation success, need for rescue medications, and surgery completion. Safety assessments, including monitoring adverse events, vital signs, and physical exams, will occur at baseline, during surgery, postoperatively on Day 1, and on Day 3 (±1 day). Approximately 528 adults aged 18 to 65 will participate, with follow-up to assess both efficacy and safety outcomes.

Researchers are studying the safety and effectiveness of Fertilo, a new engineered ovarian support cell treatment, compared to the currently approved Medicult IVM system for in vitro maturation (IVM) of eggs. This phase III trial focuses on women aged 18 to 35 who are candidates for IVF, aiming to see if Fertilo can improve the number of ongoing pregnancies at 12 weeks gestation. The study addresses infertility by comparing these two methods of maturing eggs outside the body before IVF procedures. Participants are randomly assigned to one of two groups. In one group, eggs surrounded by helper cells (cumulus oocyte complexes) are cultured in Fertilo for 30 hours. In the other group, similar eggs are cultured using the Medicult IVM system for the same duration. Both treatments are designed to support the maturation of immature eggs in the lab before fertilization. Throughout the study, participants undergo assessments including eligibility screening, ovarian imaging, hormone level measurement, and semen analysis for partners. Researchers track pregnancy outcomes up to 12 weeks gestation to measure ongoing pregnancy rates. The study also monitors safety and treatment effects, with embryo use planned within two months after cryopreservation. Participation involves regular visits and evaluations to ensure accurate and comprehensive data collection over the course of the treatment and early pregnancy period.

Researchers are evaluating the safety of daily disposable MiSight 1 Day soft contact lenses in children aged 8 to 12 years with myopia. This post-approval study aims to confirm the safety of these lenses in the intended US patient population. Safety data from a previous MiSight 1 Day study will also be used to supplement this evaluation. Participants will wear MiSight 1 Day lenses daily for three years. The study focuses on children interested in wearing contact lenses for about 10 hours per day, 6 days per week. During this time, subjects will be monitored to assess the incidence of microbial keratitis and other safety outcomes. Throughout the study, children will undergo regular eye exams to check visual acuity and eye health, ensuring they remain free from infections or complications. Parent or guardian consent and assent from the child will be obtained, and medical records will be reviewed to track outcomes related to contact lens safety over the three-year period.

Researchers are evaluating the safety and effectiveness of a drug called PF-07220060 combined with letrozole compared to other approved treatments (palbociclib, ribociclib, or abemaciclib with letrozole) in adults with breast cancer that is hormone receptor-positive and HER2-negative. This cancer has spread locally or to other parts of the body and has not been treated with systemic anti-cancer therapy for advanced or metastatic disease. The study is a Phase 3, open-label, randomized trial involving multiple centers. Participants will be randomly assigned to receive either PF-07220060 plus letrozole or the investigator's choice of one of the approved CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) combined with letrozole. The treatments are given as drugs with letrozole serving as endocrine therapy. The study compares these treatments in terms of how well they control the cancer and their safety profiles. Participants will visit the study clinic regularly for monitoring during treatment. Researchers will assess how long participants live without their disease worsening or dying from any cause, which is the main outcome measured up to about four years. The study team will monitor each participant's health and response to treatment through these visits to gather information about treatment effects and safety.