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Leiomyoma clinical trials

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NCT ID: NCT03211481 Completed - Uterine Fibroid Clinical Trials

Design of an Intra-operative Blood Conservation Pathway at Open Myomectomy

Start date: June 13, 2017
Phase:
Study type: Observational

Uterine fibroids are benign uterine masses that can be removed through a surgical procedure called a myomectomy. Myomectomy is often associated with a significant amount of blood loss for the patient. The large volume of blood lost can increase post-operative complications and lead patients to require blood replacement (blood transfusion). To reduce the amount of blood lost during the surgical procedure and the need for blood transfusions, interventions such as medications and surgical techniques have been used. While evidence in the literature exists for these techniques, there is no standardized approach to this problem in clinical practice. The objective of this study is to create a novel intra-operative blood conservation pathway, using a modified Delphi expert consensus approach, to decrease the amount of blood lost during myomectomy. The current study is expected to benefit patients undergoing myomectomy through an improved surgical experience, reduction in blood transfusion rates, and reduction in associated complications.

NCT ID: NCT03103087 Completed - Uterine Fibroid Clinical Trials

LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Start date: June 14, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.

NCT ID: NCT03092999 Completed - Leiomyoma Clinical Trials

Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)

Start date: March 28, 2017
Phase: Phase 1
Study type: Interventional

Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)

NCT ID: NCT03072446 Completed - Uterine Fibroid Clinical Trials

Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.

Start date: April 24, 2017
Phase: N/A
Study type: Interventional

The purpose of this post-market study is to evaluate UFE agents for the treatment of symptomatic uterine fibroids, using Gel-Bead compared to four other commonly used embolic agents.

NCT ID: NCT03070951 Completed - Uterine Fibroids Clinical Trials

Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

PRIMROSE 2
Start date: May 23, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

NCT ID: NCT03070899 Completed - Uterine Fibroids Clinical Trials

Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

PRIMROSE 1
Start date: April 20, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

NCT ID: NCT03049735 Completed - Uterine Fibroid Clinical Trials

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Start date: April 26, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.

NCT ID: NCT03021720 Completed - Uterine Fibroid Clinical Trials

Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial

SPARQLE
Start date: November 2016
Phase: N/A
Study type: Interventional

Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of life with femoral versus radial arterial access

NCT ID: NCT03009812 Completed - Myoma;Uterus Clinical Trials

Transverse vs Longitudinal Incision in Myomectomy

Start date: January 2017
Phase: N/A
Study type: Interventional

The Aim of the study is to compare between transverse and longitudinal uterine incision in abdominal myomectomy regarding intraoperative blood loss.

NCT ID: NCT02997787 Completed - Inflammation Clinical Trials

New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma

Start date: January 2016
Phase: N/A
Study type: Observational

Both pelvic masses and preoperative diagnosis of them have still continued as an important investigation subject. It is important to discriminate the diagnoses of leiomyoma and adenomyosis before operation especially among infertile patients. Neoplasms can alter systemic or local immune response in their originating area.Neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) can be readily determined by using of complete blood counter test (CBC). A high NLR has been shown in systemic inflammation, some gynecologic and gastrointestinal cancers and some cardiovascular diseases. The investigators aim to investigate using new inflammation markers, NLR and PLR, whether they are useful to discriminate between adenomyosis and leiomyoma. As far as is known, there have been no previous reports about the association among NLR, PLR, adenomyosis and leiomyoma.