Leiomyoma (Fibroid)

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 collecting real-world data on the Cerene Cryotherapy Device, which was approved by the FDA in 2019 for treating heavy menstrual bleeding in premenopausal women who have completed childbearing. This observational study aims to compare outcomes from routine clinical use of the Cerene device with results from previous pivotal studies, helping to understand its effectiveness and safety in everyday practice. Participants in this registry will have received treatment with the Cerene device as part of their standard medical care. The study does not involve any additional active interventions beyond this treatment. Data collection includes patient and physician surveys covering demographics, quality of life, procedural details, and clinical outcomes following the Cerene treatment. Women will participate for about 13 months, starting from enrollment and continuing through a 12-month follow-up after treatment. During this time, surveys will be completed at multiple points to assess re-intervention rates, quality of life, site of service, physician feedback, and cost analysis. The study concludes after the last participant completes her one-year follow-up visit.

Researchers are evaluating whether acupuncture, specifically the Dragons protocol, can help reduce chronic pelvic pain in women aged 21 to 65. This study focuses on non-endometriosis pelvic pain and includes women both with and without a history of sexual assault. The Dragons protocol acupuncture aims to address both physical pain and emotional trauma by combining external and internal acupuncture treatments to reprocess traumatic memories and potentially calm the nervous system. Participants will first undergo 4 weeks of standard pain care such as physical therapy, psychotherapy, or usual medical management. Then, the same women will receive acupuncture treatments once weekly for 4 weeks using the Dragons protocol. The acupuncture involves placing needles on both the back external dragons and front internal dragons of the body during each session, aiming to balance traumatic memories and pain responses. Throughout the study, participants will complete pain assessments using the Defense and Veterans Pain Rating Scale DVPRS and the Female Genitourinary Pain Index GUPI at multiple visits from week 0 to week 11. Women with a history of sexual trauma will also complete the PTSD Checklist for DSM-5 PCL-5 to evaluate changes in PTSD symptoms. Visits include screening, baseline, weekly acupuncture sessions, and follow-ups, some of which may be virtual. Researchers will monitor pain levels and quality of life to understand the impact of the acupuncture treatment.

Researchers are evaluating the effects of two investigational herbal supplements, Elix Cycle Balance and Elix Daily Harmony, on symptoms related to uterine fibroids and the quality of life in women aged 20 to 45. This 24-week, single-arm, open-label virtual study involves 42 participants who have reported moderate to severe menstrual discomfort linked to fibroids. The study aims to understand how these supplements affect symptom severity and health-related quality of life over time. Participants will self-administer Elix Cycle Balance and Elix Daily Harmony daily for 24 weeks. Each morning, about 1-2 hours after their first meal, they will mix and consume 3 droppers full of Elix Daily Harmony and 6 droppers full of Elix Cycle Balance in water at room temperature or warm. There is no placebo or comparison group, and all participants receive the same herbal supplements throughout the study. During the trial, participants will complete validated questionnaires at baseline and at regular intervals Week 4, 8, 12, 16, 20, and 24 to assess the severity of fibroid-related symptoms and changes in quality of life. Researchers will monitor symptom changes and quality of life domains through these scheduled assessments. The total participant involvement lasts 24 weeks, with no additional treatment or follow-up periods beyond this timeframe.

Researchers are examining new clinical, therapeutic, and prognostic findings to improve treatment models and develop a new algorithm for therapy in patients with uterine neoplasms, including cervical cancer, endometrial cancer, and uterine sarcoma. This observational study focuses on both operable and inoperable uterine malignancies to optimize predictive and therapeutic approaches. The study is sponsored by University Hospital Tuebingen and aims to enhance understanding and management of these cancers. The study involves analysis of circulating tumor cells CTC and disseminating tumor cells DTC, detection of Human Papilloma Virus HPV, Douglas cytology, DNA analysis in blood, proteomic analysis, and sentinel lymph node detection. These diagnostic tests are conducted to gather detailed information about the tumors and their spread. Participants with operable tumors may undergo laparoscopic, robot-assisted, or open radical gynecological surgery as part of their primary therapy. Participants will be involved in various assessments over a 12-month period, including cytology, proteomic, and DNA analyses, as well as urodynamic tests measuring nerve conduction velocity, cystomanometry, urethral pressure profiles, and uroflowmetry before and after surgery. These evaluations help monitor treatment effects and disease progression. The study requires participants to provide informed consent and to be willing and able to complete all study-specific procedures during the observation period.

Uterine fibroids are benign smooth muscle tumors of the uterus that are part of a broader group including malignant tumors with varying severity. Magnetic resonance imaging MRI is commonly used to differentiate fibroids from malignant tumors, but it has limitations that can lead to inappropriate treatment. This study aims to validate a new minimally invasive biopsy technique called ultrasound-guided transuterine vaginal biopsy BVTE to improve preoperative diagnosis and avoid unnecessary or harmful surgeries for uterine smooth muscle tumors. The procedure involves performing the BVTE under general anesthesia on the day scheduled for myomectomy or hysterectomy. The biopsy targets the center of the tumor via a transuterine route to reduce the risk of spreading cancer cells, taking 4 to 5 samples per tumor with a maximum of three tumors sampled. After the biopsy, patients undergo the planned surgery during the same operation, and all surgical specimens are sent for anatomopathological analysis. Participants will be assessed through anatomopathological comparison of the biopsy samples with the reference surgical specimens throughout the study period of 43 months. Researchers will monitor intraoperative and postoperative complications using the Clavien-Dindo classification. This study evaluates the feasibility, safety, and diagnostic accuracy of the BVTE technique as part of current clinical practice for women requiring surgical treatment for uterine smooth muscle tumors.

Researchers are evaluating patient-reported pain, bleeding, and the efficiency of devices used during intrauterine device IUD insertions. This trial compares a new FDA-approved, atraumatic suction cervical stabilizer called Carevix with the standard single-tooth tenaculum, which is considered more traumatic. The study also looks at provider satisfaction and ease of use for these devices, focusing on differences in pain scores between patients who have never given birth nulliparous and those who have multiparous. Participants will be randomly assigned to receive either the Carevix device or the standard tenaculum during their IUD insertion procedure. Providers will perform the procedures using the assigned device, and participants will complete surveys about their pain experience and satisfaction immediately after the procedure. The study collects additional information on cultural background, previous contraceptive use, and reasons for choosing IUD insertion or anticipating removal. During the trial, participants will be evaluated for pain at several points before the procedure, during cervix grasping and traction, at IUD placement, and five minutes after completion. Providers will assess ease of device use, number of placement attempts, bleeding, and overall satisfaction right after the procedure. Patient satisfaction and bleeding cessation time will also be measured. The study runs from March 2026 to March 2027, with ongoing assessments during and immediately after the IUD insertion.

Researchers are evaluating the impact of Transvaginal Natural Orifice Transluminal Endoscopic Surgery vNOTES compared to conventional abdominal laparoscopy CAL for benign adnexal surgery in women aged 18 to 70. The study aims to confirm that vNOTES does not negatively affect womens sexual function after surgery, addressing concerns about vaginal scarring and its effects on sexual activity. Secondary goals include assessing vNOTES efficiency, complications, and the quality of histological analysis of surgical specimens. Participants will be randomly assigned to receive either the vNOTES or CAL surgical technique for procedures such as cystectomy, oophorectomy, salpingectomy, or tubal sterilization. Both approaches involve minimally invasive surgery, with vNOTES using the vaginal route and CAL using abdominal laparoscopy. The study also examines pain, hospital stay length, patient satisfaction, and surgical complications during and up to 30 days after surgery. Women in the study will complete questionnaires before surgery and at 3 and 6 months afterward to assess sexual function, couple satisfaction, and pain during sex. Medical and general data will be collected at enrollment, during hospitalization, and one month post-surgery. The main outcomes measured include quality of sexual life and postoperative recovery, while monitoring safety and the effectiveness of both surgical methods throughout the study period.

This research aims to understand awareness, knowledge, and help-seeking behaviors related to gynecological problems among women in Hong Kong. It focuses on patients with conditions like PCOS, endometriosis, miscarriage, or infertility, as well as the general public. The study addresses cultural and social factors that may influence womens health behaviors, especially where Western and Chinese values intersect and where health literacy may be limited. Participants include two groups gynecological patients aged 13 to 60 who have used or plan to use medical services for their conditions, and women aged 13 to 60 from the general public recruited online. Both groups will complete questionnaires designed to evaluate their understanding and behaviors regarding gynecological health issues. The study compares these groups to identify differences and barriers in seeking care. During the study, participants will provide information through questionnaires that explore their knowledge and actions related to PCOS, endometriosis, miscarriage, and infertility. Researchers will look at how social and cultural factors affect these behaviors over about one year. The study is observational, with no treatment involved, and aims to inform future strategies to improve womens health outcomes in Hong Kong.

Researchers are conducting a prospective, multicenter observational study to follow up on individuals treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. The study focuses on collecting data regarding the safety and performance of these particles over a six-month period. The study is sponsored by Merit Medical Systems, Inc. and involves adult women with symptomatic uterine fibroids suitable for embolization. The intervention being observed is the use of Bearing nsPVA Embolization Particles, which are irregularly-shaped, biocompatible particles made from polyvinyl alcohol. These particles are designed to block or reduce blood flow in targeted blood vessels through selective catheter placement. The study tracks outcomes following the use of this device in treating uterine fibroids, with no comparison groups or placebo treatments. Participants will be monitored for safety outcomes up to 30 days and effectiveness outcomes through six months after treatment. Data collection will include evaluations related to the devices performance and participant health status during follow-up visits. The overall participation duration includes the initial treatment and subsequent monitoring over half a year to assess treatment impact and safety.