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Uterine Fibroids clinical trials

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NCT ID: NCT05026502 Terminated - Uterine Fibroids Clinical Trials

A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules

REACH
Start date: October 5, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT03400956 Terminated - Uterine Fibroids Clinical Trials

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)

Start date: January 24, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids

NCT ID: NCT03400943 Terminated - Uterine Fibroids Clinical Trials

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)

Start date: January 17, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo. The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

NCT ID: NCT03240523 Terminated - Uterine Fibroids Clinical Trials

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

ASTEROID 5
Start date: July 31, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to describe the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal. The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids.

NCT ID: NCT02811159 Terminated - Uterine Fibroids Clinical Trials

An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

Start date: July 26, 2016
Phase: Phase 2
Study type: Interventional

To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] and meet eligibility criteria.

NCT ID: NCT02425878 Terminated - Uterine Fibroids Clinical Trials

Ulipristal Acetate 10 mg and Asisted Reproduction

Start date: October 19, 2015
Phase: Phase 3
Study type: Interventional

Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable intramural fibroids not distorting the uterine cavity within a program OVD, after administration of uPA in a dose of 10 mg orally daily for 12 weeks

NCT ID: NCT01998854 Terminated - Uterine Fibroids Clinical Trials

Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation

Start date: February 2013
Phase: N/A
Study type: Observational

Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system. Particular attention will be directed to recording safety outcomes including incidence of uterine cavity synechiae. In addition, information on quality of life will be collected. Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.

NCT ID: NCT01842789 Terminated - Uterine Fibroids Clinical Trials

Post Market Evaluation of Acessa With TAG

TAG
Start date: April 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to test both user preference and speed of targeting with the use of the Acessa System with Targeting Animation Guidance (TAG).

NCT ID: NCT01834703 Terminated - Uterine Fibroids Clinical Trials

Uterine Artery Embolization(UAE) Versus High-Intensity-Focused-Ultrasound(HIFU) for Treatment of Uterine Fibroids

Start date: May 2009
Phase: N/A
Study type: Interventional

This study aimed to evaluate the clinical effectiveness and adverse effects of Uterine Artery Embolization (UAE), High-Intensity-Focused-Ultrasound (HIFU) in treating patients with uterine fibroid.

NCT ID: NCT01786226 Terminated - Uterine Fibroids Clinical Trials

Mifepristone to Treat Uterine Fibroids

Start date: March 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period. The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.