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Menorrhagia clinical trials

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NCT ID: NCT05722444 Active, not recruiting - Menstruation; Heavy Clinical Trials

Sleep and Health Outcomes in Women With Heavy Menses

Start date: February 6, 2023
Phase: N/A
Study type: Interventional

This study will evaluate subjective sleep over three consecutive menstrual cycles (menses and non-menses) in females reporting heavy menstrual bleeding. Following a baseline phase of one menstrual cycle, study subjects will use a standardized nighttime feminine product during menstruation for their second cycle. For the third cycle, subjects will continue to use the standardized menstrual product with behavioral modification that includes refraining from those sleep behaviors used to avoid nighttime menstrual leakage.

NCT ID: NCT05445167 Active, not recruiting - Clinical trials for Uterine Fibroids (MeSH Heading: Leiomyoma)

A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain

Start date: October 11, 2022
Phase: Phase 3
Study type: Interventional

Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain

NCT ID: NCT05440383 Active, not recruiting - Clinical trials for Uterine Fibroids (MeSH Heading: Leiomyoma)

A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

Start date: October 11, 2022
Phase: Phase 3
Study type: Interventional

Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia

NCT ID: NCT04856306 Active, not recruiting - Clinical trials for Heavy Menstrual Bleeding

Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L

Magical
Start date: April 12, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT04778072 Active, not recruiting - Clinical trials for Iron Deficiency Anemia

A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects

Start date: October 8, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04477837 Active, not recruiting - Clinical trials for Heavy Menstrual Bleeding

Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants

Start date: October 15, 2020
Phase:
Study type: Observational [Patient Registry]

Prospective comparison of the incidence of heavy menstrual bleeding (HMB) in women of reproductive age treated with direct oral anticoagulants (DOACs)

NCT ID: NCT04267562 Active, not recruiting - Menorrhagia Clinical Trials

Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness

Start date: February 28, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03271489 Active, not recruiting - Uterine Fibroids Clinical Trials

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Start date: January 4, 2017
Phase: Phase 3
Study type: Interventional

This is phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study is double-blinded in the first year and an open-label for the next three years.

NCT ID: NCT02449304 Active, not recruiting - Clinical trials for Heavy Menstrual Bleeding

Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device

Start date: March 2015
Phase: Phase 4
Study type: Interventional

All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy that persists despite treatment with recommended pharmacological agents(1,2), who have no desire to preserve their fertility and are willing to have an endometrial ablation will be invited to participate. Eligible women with HMB will undergo radiofrequency G4 endometrial ablation in either an inpatient or outpatient setting according to their preference. Outcomes will be assessed by administering postal questionnaires to measure menstrual bleeding symptoms including rates of amenorrhoea, dysmenorrhoea and life quality at baseline and at 6, and 12 months after ablative treatment. After the main study, there will be an additional evaluation of the long-term effects of outpatient ablative treatments of the endometrium by postal survey at 5 years.

NCT ID: NCT01979861 Active, not recruiting - Menorrhagia Clinical Trials

Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding

Start date: February 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)