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Menorrhagia clinical trials

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NCT ID: NCT06452342 Not yet recruiting - Clinical trials for Venous Thromboembolism

TRanEXamic Acid to Decrease Heavy Menstrual Bleeding in Individuals Anticoagulated for Venous Thromboembolism Pilot Study

T-REX HMB
Start date: June 2024
Phase: Phase 4
Study type: Interventional

T-REX HMB is a pilot randomized controlled trial (RCT) designed to assess the feasibility of a full trial comparing tranexamic acid (TXA) to placebo in decreasing HMB in premenopausal individuals anticoagulated for VTE. Strong data supports TXA as an effective and safe agent at decreasing HMB in the general population, but its use in those with VTE has been limited by a lack of data for its efficacy in anticoagulated individuals and theoretical concerns of its prothrombotic effects.

NCT ID: NCT06205095 Not yet recruiting - Clinical trials for Von Willebrand Diseases

A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients With VWD

EMPOWER
Start date: June 2024
Phase: Phase 3
Study type: Interventional

The EMPOWER trial is a pilot multi-center, placebo-controlled (normal saline), double-blind (patient and outcome assessor), crossover, 2-year randomized trial in female outpatients with von Willebrand disease (VWD) and heavy menstrual bleeding to determine trial feasibility and viability, and to explore assay sensitivity of the proposed efficacy clinical outcomes for a definitive randomized controlled trial

NCT ID: NCT06122363 Enrolling by invitation - Clinical trials for Heavy Menstrual Bleeding

Impact of Incomplete Endometrial Ablation

Start date: March 1, 2023
Phase:
Study type: Observational

The aim of the proposed protocol is to study the impact of incomplete endometrial ablation on the PBAC score, reintervention, satisfaction, controlled bleeding and dysmenorrhea at 24 months after Novasure endometrial ablation, in women with heavy menstrual bleeding treated at Máxima Medical Centre Veldhoven, in The Netherlands.

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: NCT05916469 Not yet recruiting - Clinical trials for Heavy Menstrual Bleeding

Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

HMB-BD
Start date: July 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this multicenter prospective observational study and registry of U.S. adolescents and young adults with heritable bleeding disorders is to determine the bleeding outcomes, satisfaction, hemostatic parameter changes, and patient reported quality of life after 6 months of use of either of two commonly used hormonal treatments for menstrual suppression - levonorgestrel intrauterine device (LNG-IUD) and norethindrone acetate (NETA). Under this application we will compare the two treatments and compare outcomes after LNG-IUD treatment results to a control group without a bleeding disorder, with the goal of determining the benefits and expected outcomes of these treatment options for this population.

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: NCT05788172 Completed - Anemia Clinical Trials

Measuring Menstrual Iron Loss Using the Iron Isotope Dilution Technique

MBL_Loss
Start date: March 1, 2023
Phase:
Study type: Observational

It is very difficult to quantify menstrual blood loss, the reference method is a tedious one. This is a problem, as it is not conducive to objectively measuring menstrual blood loss and understanding the contribution of menstrual iron loss to iron deficiency anemia. With this study, the investigators aim to investigate iron loss during the menstrual cycle and aim to validate a much simpler technique.