View clinical trials related to Heavy Menstrual Bleeding.
Filter by:Uterine Fibroids (UF) are noncancerous (benign) tumors that commonly occur in up to 80% of women of reproductive age. Symptoms can include heavy menstrual bleeding (HMB), low back pain, urinary frequency and urgency, gastrointestinal symptoms, and fatigue. In participants with UF, this study will prospectively assess changes in patient-reported quality of life and patient-reported effectiveness in controlling HMB when treated with elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules (elagolix + E2/NETA). Around 200 adult premenopausal female participants in the United States with a diagnosis of HMB associated with UF and are prescribed elagolix + E2/NETA by their physicians as per standard of care will be enrolled in this direct-to-patient observational study for up to 6 months. Participants will have been prescribed elagolix + E2/NETA within the last 30 days prior to enrollment and will continue to take elagolix + E2/NETA throughout study participation. There may be a higher burden for participants in this study compared to standard of care. Electronic patient reported outcomes (ePROs) will be collected at baseline, 1, 3 and 6 months to assess the impact of Elagolix + E2/NETA on patient-reported quality of life.
Iron deficiency anemia affects over half of girls and young women with heavy periods and is the most common cause of anemia worldwide. Most girls with heavy periods who also have iron deficiency anemia are prescribed iron to take by mouth every day by their doctor. There are some studies showing that taking iron every other day may actually help the iron be absorbed into the bloodstream better. This study is trying to compare how taking iron every other day compares to taking iron daily for treatment of anemia. The goal of this clinical research study is to learn which of the two methods of care will be the best way for girls and young women with iron deficiency anemia to take iron supplementation.
One of the AUB symptoms, heavy menstrual bleeding (HMB), can lead to iron deficiency and iron deficiency anemia and in acute and severe cases, can necessitate emergency medical care. This study's focus is on the symptom of HMB which has a number of benign causes. The investigative device, the IUB SEAD™, is a novel spherical endometrial ablation device developed to allow for simple, office-based chemical EA to treat benign causes of the symptom of HMB. The suggested procedure is expected to be simpler than the currently available EA methods and yet should still reduce the need for hysterectomy.
This is a prospective cohort study comparing the novel FDA-approved oral GnRH antagonist ORIAHNN (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) to uterine artery embolization (UAE) or myomectomy (abdominal, laparoscopic, or hysteroscopic) for treatment of heavy menstrual bleeding due to leiomyomas. Uterine leiomyomas, also called fibroids, are hormone-dependent growths in the uterine muscle that are common in reproductive-age women (1). Leiomyomas can often lead to heavy menstrual bleeding. Definitive treatment for abnormal uterine bleeding due to leiomyomas is hysterectomy, but for patients who desire uterine conservation, a variety of treatment options exist. Regulation of menses with combined oral contraceptives or progestin only oral formulations are generally considered first line treatment but are not curative or effective for many patients. Another treatment option is a myomectomy, which is the surgical resection or removal of myomas. Myomectomy can be performed via hysteroscopy or laparoscopy, or by a vaginal or an abdominal approach. The route of removal depends on myoma location and patient symptoms. Another treatment option is Uterine fibroid or uterine artery embolization (UFE/UAE). UAE is a minimally invasive procedure where permanent particles are delivered to and block/embolize the blood supply to the myoma via a fluoroscopy directed arterial catheter. This typically leads to a decrease in fibroid size and associated bleeding (2). ORIAHNN, an oral GnRH antagonist that was FDA-approved in 2020, has demonstrated significant decrease in myoma-associated heavy menstrual bleeding compared to placebo (1) but has not been compared to other standard of care interventions. The primary objective of this study is to compare this novel medication to the common AUB-L treatments UAE and Myomectomy.
A randomized, placebo controlled, parallel group, double blind study to compare the 3-month adherence and efficacy of Active Iron in subjects with or at-risk of iron deficiency and a history of intolerance to oral iron. Subjects with intolerance and treatment failure due to oral iron (male and female subjects, aged 18 to 55 years, with mild to moderate iron deficiency, with or without anaemia) are eligible. Sixty subjects are randomised into three groups (14 mg elemental iron, 25mg elemental iron and 50mg elemental iron daily). The primary objective is to assess adherence/persistence (including using pill counts). Secondary objectives are to assess gastrointestinal tolerability, haematological efficacy and health related quality of life.
Prospective comparison of the incidence of heavy menstrual bleeding (HMB) in women of reproductive age treated with direct oral anticoagulants (DOACs)
To determine if uterine cavity length on transabdominal pelvic ultrasound corresponds to uterine cavity length at time of IUD insertion. If transabdominal pelvic ultrasound is validated as a tool for measuring uterine cavity length, it can be used to guide physicians and subsequently patients in IUD insertion planning.
The EASE Clinical Trial is prospective, multi-center, single-arm (open-label), non-randomized, clinical trial to evaluate the Minitouch Endometrial Ablation System ("Minitouch System") in premenopausal women with menorrhagia.
This study investigates whether intravenous (IV) iron [Feraheme (ferumoxytol) injection)] is a better treatment than oral iron pills (ferrous sulfate) for correcting anemia in women who have heavy menstrual bleeding and anemia. Investigators will study whether women's blood counts respond better, respond more quickly, and if women prefer the IV treatment or the oral treatment. Women who have heavy menstrual bleeding and anemia will be randomly assigned to receive treatment with either oral iron pills or IV iron infusions. Investigators will then check whether and how quickly the anemia improves, and survey participants on how satisfied they were with the treatment.
This study evaluates the effectiveness and safety of ulipristal acetae (UPA) in women with symptomatic uterine fibroids. Those who fulfilled inclusion/exclusion criteria will be treated UPA at daily dose of 5mg.