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Menorrhagia clinical trials

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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: NCT04205266 Recruiting - Clinical trials for Anemia, Iron Deficiency

IV Iron vs Oral Iron for Treatment of Anemia in Women With Abnormal Uterine Bleeding

Start date: February 14, 2020
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04132349 Terminated - Uterine Fibroid Clinical Trials

Ulipristal Acetate in Symptomatic Uterine Fibroid

Start date: October 23, 2019
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT03886220 Completed - Uterine Fibroids Clinical Trials

A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Start date: April 12, 2019
Phase: Phase 4
Study type: Interventional

The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.

NCT ID: NCT03794895 Completed - Clinical trials for Women's Health: Amenorrhea/Dysmenorrhea

Prediction of Response to IUCD Associated Menorrhagia Using Doppler

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Studying the efficacy of uterine artery doppler in predicting response to mefenamic acid in women having IUCD associated menorrhagia

NCT ID: NCT03751800 Completed - Menorrhagia Clinical Trials

A Study Run at Multiple Study Sites to Test Whether the SAMANTA Questionnaire That is Used to Diagnose Heavy Menstrual Bleeding (HMB), Can Also be Used to Assess Changes of Severity of HMB in Women With HMB Who Are Treated During 12 Months With a Chronic Hormonal Treatment

SAMIRA
Start date: December 12, 2018
Phase:
Study type: Observational

A study run at multiple study sites in Spain to test whether the SAMANTA questionnaire that is used to diagnose heavy menstrual bleeding (HMB), can also be used to assess changes of severity of HMB in women with HMB who are treated during 12 months with a chronic hormonal treatment. Patients that are treated with chronic hormonal treatment as Levonorgestrel (trade name Mirena) or with a combination of estradiol valerate and dienogest (trade name Qlaira) or with Medroxyprogesterone acetate (trade name Progevera) and any new hormonal treatment marketed in Spain that has the indication for HMB in routine gynaecological practice are observed for 12 months in this study or for a shorter period in time in case of withdrawal. The study aims also to describe the overall satisfaction of women with their chronic hormonal treatment for HMB and how the women think their menstrual bleeding has changed. In addition the study aims to describe the changes of the score that is derived from the SAMANTA questionnaire in relation to Quality of Life. Quality of Life is measured with the SF36v2 questionnaire. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.

NCT ID: NCT03751124 Completed - Uterine Fibroids Clinical Trials

Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Start date: October 16, 2018
Phase: Phase 3
Study type: Interventional

The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients with uterine fibroids who have completed a total of 52 weeks of treatment, including a 24-week treatment period in a parent study (study MVT-601-3001 or MVT-601-3002) and a 28-week treatment period in the open-label extension study (MVT-601-3003), and who meet the definition of responder, defined as a patient who demonstrates a menstrual blood loss of < 80 mL and at least a 50% reduction from parent study baseline menstrual blood loss volume on the alkaline hematin analysis of the feminine products returned at Week 48 in the extension study.

NCT ID: NCT03725306 Not yet recruiting - Menorrhagia Clinical Trials

Librata Endometrial Ablation Device Treatment to Reduce Menstrual Blood Loss

LEADER
Start date: January 1, 2019
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the endometrial ablation device Librata in reducing menstrual blood loss at 12 months post-treatment when used in pre‑menopausal women with menorrhagia due to benign causes for whom childbearing is complete.

NCT ID: NCT03704454 Recruiting - Menopause Clinical Trials

The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This is a pilot study to test whether PYC can improve climacteric symptoms for women who have experienced either surgically or medically induced menopause as part of their treatment for breast or gynecologic cancers.

NCT ID: NCT03670680 Recruiting - Menorrhagia Clinical Trials

Efficiency of Lina LibrataTM System

THERMOLIB
Start date: October 16, 2018
Phase: N/A
Study type: Interventional

Menometrorrhagia is the first cause of consultation in gynecology. Etiology of menometrorrhagia is varied, but in majority of cases no underlying pathology is found, they are said functional idiopathic menometrorrhagia . In case of failure of medical treatment, for women who do not wish to preserve reproduction possibilities, a surgical treatment by endometrectomy (destruction of the uterine endometrial epithelial) can be proposed. Currently, a new system, Lina LibrataTM is available on the market. This system allows destructing endometrial membrane with a balloon which offer several advantages compared to present used system. Specially, it does not require dilatation of uterus's cervix and it reduces the pain. The investigator make hypothesis that the use of the system Lina LibrataTM does not cause pain and can be thus used under local anesthetic in ambulatory surgery. With the aim of developing ambulatory care, the main objective of this prospective monocentric study is to estimate the efficiency of Lina LibrataTM system in the treatment of functional idiopathic menometrorrhagia. Secondary objectives are to estimate the pain during the procedure, the rate of per and post-complications and quality of life.