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Menorrhagia clinical trials

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NCT ID: NCT06064851 Recruiting - Clinical trials for Heavy Menstrual Bleeding

Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients

HMB/VWD
Start date: October 27, 2023
Phase: N/A
Study type: Interventional

The objectives of this study are to determine if transcutaneous auricular neurostimulation (tAN) can modulate hemostasis, improve perceived quality of life, and improve pain during the menstrual cycle of von Willebrand Disease (VWD) patients.

NCT ID: NCT05922657 Recruiting - Menorrhagia Clinical Trials

A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device

Progress
Start date: June 9, 2023
Phase:
Study type: Observational [Patient Registry]

Channel Medsystems, Inc., the manufacturer of the Cerene® Cryotherapy Device (Cerene), is initiating a prospective, observational registry, the Progress registry, to gather data during real world utilization of the Cerene® Cryotherapy Device (Cerene). The primary objective of this registry is to bridge the gap between clinical results and outcomes achieved and reported during the pivotal study of Cerene and those obtained during its real-world use.

NCT ID: NCT05862805 Recruiting - Clinical trials for Menstrual Bleeding, Heavy

PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis

Start date: July 12, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to learn more about the role of blood clotting factor proteins and cells in menstrual (period) bleeding. The investigators are hoping to identify differences in these proteins and cells in the menstrual blood of individuals with heavy periods compared to menstruating individuals who do not have heavy periods.

NCT ID: NCT05856838 Recruiting - Clinical trials for Menstrual Bleeding, Heavy

NovaSure Study: Endometrial Ablation in Women With Heavy Menstrual Bleeding

RAMBOS
Start date: November 24, 2023
Phase: N/A
Study type: Interventional

Heavy menstrual bleeding (HMB) affects 30% of women worldwide. It negatively influences physical activity, work productivity, sexual life and overall quality of life. In 2018, the FIGO (International Federation of Gynaecology and Obstetrics) revised its definition of AUB (FIGO-AUB system 1) and the classification of the underlying causes (FIGO-AUB system 2). It includes HMB, which is a subjective parameter and therefore patient determined. The FIGO-AUB system 2 describes the underlying causes of AUB through the acronym PALM-COEIN: Polyps, Adenomyosis, Leiomyomatosis, Malignancy, Coagulopathy, Endometrial, Iatrogenic and not otherwise specified. The National Institute for Health and Care Excellence (NICE) guideline on HMB recommends the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg as the treatment of first choice in women with no identified pathology, fibroids less than 3cm in diameter, which are not causing distortion of the uterine cavity, or adenomyosis. If a woman declines a LNG-IUS, non-hormonal (fibrinolytics or non-steroidal anti-inflammatory drugs (NSAIDs)) and other hormonal pharmacological treatments can be considered. If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, an endometrial ablation (EA) or hysterectomy can be an alternative option. The latter is a definitive solution, but it is an invasive option, with a risk of serious complications. An EA is a procedure that destroys the endometrium. It aims to reduce the menstrual flow, sometimes causing amenorrhea. Initially, it was performed through hysteroscopy. Later on, second-generation devices became available. NovaSure is an example of a second-generation EA device, using a bipolar radiofrequency impedance-controlled system that evaporates endometrial tissue. The EA procedure is a minimally invasive alternative to hysterectomy. It is known to result in amenorrhea in 50% of women, with satisfaction rates between 80-96% and reported reintervention rates around 10%. Moreover, it is feasible to perform the procedure using only local anaesthesia. The investigators aim to assess the patient acceptability and feasibility of NovaSure EA in an outpatient setting with a short observation (≤4 hours) This observational prospective cohort study will be performed in the Ghent University Hospital (Ghent), Leuven Catholic University Hospital (Leuven) and Turnhout General Hospital (Turnhout). The surgeon performing the procedure will be the same per institution. The duration of the study is estimated at 4 months.

NCT ID: NCT05820321 Recruiting - Physical Inactivity Clinical Trials

Effects of Dietary Nitrate Intake on Physical Performance of Middle-aged Women

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Through a randomized, crossover, triple-blind, placebo-controlled clinical trial, 15 physically inactive hypertensive women will participate a 8-day trial, each with two intervention protocols: 1) placebo and 2) beetroot; in which will ingest beet juice with or without NO3 in its composition with a 8-day washout interval.

NCT ID: NCT05685199 Recruiting - Clinical trials for Heavy Menstrual Bleeding

Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding

Start date: May 10, 2024
Phase:
Study type: Observational

In this study, researchers want to learn about the connection between heavy bleeding issues and joint hypermobility (loose joints). They want to know if these issues may indicate other connective tissue problems in girls and women with heavy menstrual bleeding who do not have a known cause. Primary Objective - Compare the severity of heavy menstrual bleeding (HMB) in women with and without Generalized joint Hypermobility Syndrome Disorder/hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using bleeding scores. Secondary Objectives - Compare the frequency of co-morbidities in women with and without G-HSD/hEDS.

NCT ID: NCT05620355 Recruiting - Uterine Fibroids Clinical Trials

Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.

Start date: December 16, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the superior efficacy versus placebo of BG2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

NCT ID: NCT05606146 Recruiting - Clinical trials for Heavy Menstrual Bleeding

IUB SEAD RED (Revolutionary Endometrial Ablation Device Study)

HMB
Start date: February 23, 2023
Phase: N/A
Study type: Interventional

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 a hysterectomy.

NCT ID: NCT05538689 Recruiting - Pelvic Pain Clinical Trials

Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)

SOUL
Start date: November 20, 2022
Phase: Phase 4
Study type: Interventional

In this project, the proposition is that the use of daily dosed Myfembree ( a combination of relugolix with estradiol and norethindrone acetate), FDA-approved medication to treat heavy menses fibroid-related symptoms, has the potential to delay the recurrence of fibroid symptoms, prolong the improved quality of life and delay the need for re-intervention after uterine sparing surgery versus the routine standard of care.

NCT ID: NCT05442827 Recruiting - Clinical trials for Uterine Fibroids With Menorrhagia

A Phase II/III Study of Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia With Uterine Fibroids

Start date: September 10, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Phase II:To explore the optimal effective dose of SHR7280 tablets in subjects with menorrhagia with uterine fibroids as a phase III treatment dose. Phase III:To evaluate the efficacy of the selected dose of SHR7280 compared with placebo in reducing menstrual bleeding in subjects with menorrhagic uterine fibroids in phase II studies.