Chronic Pelvic Pain

This research aims to evaluate knee joint position sense, pain, and dynamic balance in females with primary dysmenorrhea, a common menstrual condition affecting many adolescent girls and women of reproductive age. The study is observational and focuses on young adult females aged 18 to 25 years. It addresses a gap in understanding how primary dysmenorrhea impacts physical therapy-relevant factors such as knee joint function and balance. Participants will be grouped based on their dysmenorrhea severity: those with no or mild symptoms and those with moderate to severe symptoms. There is no intervention applied during the study; instead, measurements are taken to compare these groups. The study observes participants during their menstrual cycle at specific times to assess balance and knee joint sense. During the study, researchers will measure overall stability indexes including antero-posterior and medio-lateral stability, as well as knee joint position sense and pain on the first and fourth days of menstruation. These assessments will help understand the effects of primary dysmenorrhea on physical balance and knee function. The total study duration includes these menstrual cycle assessments, with no additional intervention or treatment.

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are investigating why some men with Benign Prostatic Hyperplasia (BPH), a common condition causing urinary problems due to prostate enlargement, do not respond to the typical treatment drug Finasteride. The study focuses on understanding resistance to this treatment and hopes to use noninvasive methods like MRI to detect prostate inflammation and predict which patients will not benefit from Finasteride, allowing for alternative treatments in the future. Men eligible for the study will receive Finasteride as standard care for BPH symptoms, particularly those with moderate urinary symptoms and a prostate size over 40cc. Participants will undergo prostate MRIs and biopsies, along with blood and urine tests, before starting treatment. They will be monitored every six months with symptom assessments and have follow-up MRIs at three years to track changes in prostate size and inflammation, while tissue samples will be analyzed for gene expression and hormonal levels. Throughout the study, participants will attend clinic visits to evaluate urinary symptoms and treatment response, with a key assessment at 12 months to measure the effect of Finasteride. Researchers will collect detailed data including MRI scans, prostate tissue analyses, and hormone tests to understand treatment resistance. The study aims to improve how BPH is managed by identifying patients unlikely to respond to current therapy, with monitoring continuing over several years to gather comprehensive information.

Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled, 4-way cross-over trial to study the effects of pudafensine on vulvodynia, specifically provoked vestibulodynia. The goal is to evaluate the safety and efficacy of a single dose of pudafensine in reducing pain in the vaginal vestibule. This study aims to better understand how pudafensine affects vestibular pain threshold in patients with this condition. Participants receive single doses of pudafensine or placebo in a randomized sequence across four treatment periods. The study includes three different doses of pudafensine and one placebo group, with each participant experiencing all four treatments at different times. The crossover design allows comparison of the drug's impact versus placebo within the same individuals. During the study, participants undergo the Vestibular Pain Threshold Test to measure pain changes in the vaginal vestibule. This evaluation continues through study completion, averaging about one year. Safety and pain response are monitored throughout the trial. Participants are women aged 18 to 65 diagnosed with vulvodynia, and the study excludes those with certain other vulvar or pelvic conditions that could affect pain assessment.

Researchers are evaluating the effects of vipoglanstat on non-menstrual pelvic pain (NMPP) related to endometriosis in women aged 18 to 44 years. This Phase 2 trial aims to assess how well vipoglanstat works and its safety in treating moderate to severe pain caused by endometriosis. The study is sponsored by Gesynta Pharma AB and is designed as a randomized, double-blind, placebo-controlled trial.

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 GenSci048 for treating moderate to severe pain associated with endometriosis in pre-menopausal women. This randomized, double-blind, placebo-controlled Phase IIa study aims to assess the safety and effectiveness of GenSci048 in relieving endometriosis-related pain. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. and focuses on women aged 18 to 49 who have been diagnosed with endometriosis within the past 10 years. Participants will receive either GenSci048 or a placebo by subcutaneous injection every four weeks. The treatment period includes regular dosing and monitoring over several months. Researchers will compare changes in pain levels, including menstrual pain and non-menstrual pelvic pain, using a numeric rating scale from baseline through week 24 and up to 52 weeks for secondary outcomes. During the study, participants will attend scheduled visits for assessments of pain, use of rescue medications, and overall health evaluations. Safety will be monitored through adverse event reporting for up to approximately 56 weeks. Pain changes will be measured with standardized scales, and participants will be asked about their impressions of change at multiple time points. Total participation may last over one year, including treatment and follow-up periods.

Researchers are evaluating a dietary intervention in women with endometriosis to see if it improves pain and quality of life. This randomized, controlled study compares the effects of a whole food plant-based diet against continuing a usual diet over 12 weeks. The study aims to understand how diet may affect symptoms in women diagnosed with endometriosis. Participants are randomly assigned to either follow the whole food plant-based diet or remain on their usual diet for the 12-week period. The study includes two groups: one receiving the dietary intervention and the other serving as a control group continuing their normal eating habits. The intervention is monitored throughout the study duration to assess its impact. During the study, participants will attend visits and follow procedures to track their health and adherence to the assigned diet. Researchers will measure total pain scores after 12 weeks as the primary outcome. Participants will also be monitored for safety and compliance during the study period, which lasts approximately three months.

Researchers are studying women with dysmenorrhea, a condition involving painful periods, to see if they have a stronger musculoskeletal and autonomic nervous system response to painful internal stimuli compared to women without this pain. The study also aims to explore how interoceptive awareness, or the ability to sense internal body signals, might affect this relationship. This investigation seeks to better understand pain perception and related body changes in women with this condition. The study involves two groups: women with moderate to severe menstrual pain and age-matched controls with mild or no pain. Participants will attend two sessions: one for information and preparation, including tracking their menstrual cycle and heart rate variability (HRV) daily for 30 days, and a lab session where they will receive a controlled visceral pain stimulus. During the lab visit, hip mobility and muscle strength will be measured before and after the pain stimulus, and HRV will be recorded throughout. Participants will fill out questionnaires, perform daily HRV measurements with a phone app, and attend a lab session where detailed physical and physiological assessments occur. The study will measure changes in hip range of motion, muscle strength, and heart rate variability immediately after the pain stimulus. It will also assess interoceptive awareness during testing. The total participation includes daily monitoring for about a month and a single lab visit, with safety and comfort maintained throughout.

Researchers are evaluating STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in adults with advanced solid tumors that are antigen-rich. This open-label, multicenter Phase 1/2 study aims to assess the safety, tolerability, and preliminary clinical activity of STAR0602 in participants with unresectable, locally advanced, or metastatic solid tumors where standard therapies are not effective or suitable. The study has two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine safety, the maximum tolerated dose, and the recommended dose for Phase 2. In Phase 2, participants receive STAR0602 at the established recommended dose to further evaluate safety and clinical activity. Clinical activity is measured by tumor response rates, duration of response, disease control, and progression-free survival. Participants will receive STAR0602 infusions in cycles lasting 28 days. Researchers will monitor safety by tracking dose-limiting toxicities, adverse events, and serious adverse events for up to three years. Tumor responses and survival outcomes are also assessed over this period. Pharmacokinetic measures and anti-drug antibody formation will be evaluated at specified cycles. The total study duration and follow-up can extend up to three years to gather comprehensive safety and activity data.