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Leiomyoma clinical trials

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NCT ID: NCT03757975 Recruiting - Fibroid Uterus Clinical Trials

Impact of Hysterectomy on Quality of Life and Urethral Length

Start date: July 1, 2018
Phase:
Study type: Observational

To establish the impact of hysterectomy on sexual function, urethral length and quality of life

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: NCT03744507 Completed - Endometriosis Clinical Trials

Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

Start date: August 3, 2018
Phase:
Study type: Observational

The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.

NCT ID: NCT03699176 Withdrawn - Uterine Fibroids Clinical Trials

Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

ASTEROID 7
Start date: October 27, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study is 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 are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

NCT ID: NCT03586947 Not yet recruiting - Clinical trials for Vitamin D Deficiency

Association Between Vitamin D and the Risk of Uterine Fibroids

ABVDATROUF
Start date: September 15, 2018
Phase: N/A
Study type: Interventional

The aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could reduce the risk of uterine fibroids in reproductive stage women.

NCT ID: NCT03584529 Not yet recruiting - Clinical trials for Vitamin D Deficiency

Association Between Vitamin D and the Development of Uterine Fibroids

Start date: September 15, 2018
Phase: N/A
Study type: Interventional

the aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could inhibit the growth of uterine fibroids in reproductive stage women.

NCT ID: NCT03570879 Not yet recruiting - Myoma;Uterus Clinical Trials

Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.

MYMOTE-1
Start date: May 1, 2022
Phase:
Study type: Observational

Laparoscopic myomectomy represents the fertility-sparing gold standard approach for the management of subserosal and intramural uterine myomas: this technique allows faster recovery, less complications and improved surgical outcomes than laparotomy. Despite these validated cornerstones of minimally invasive gynecology, the best approach for specimen retrieval is still debated. Among these approaches, surgical specimen retrieval after laparoscopic myomectomy could be performed by mini-laparotomy, by power morcellation using morcellator inserted through one of the ancillary trocars, or by transvaginal extraction through an endobag inserted at level of the posterior vaginal fornix (between the utero-sacral ligaments). Unfortunately, mini-laparotomy has poor esthetic outcome and does not conform the current standards of minimally invasive surgery. In addition, on 24 November 24 2014 the Food and Drug Administration updated a Safety Communication about Power Morcellation, warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids, due to the risk of spreading an unsuspected uterine sarcoma within the abdomen and pelvis. Considering this scenario, transvaginal extraction may represents a feasible approach for specimen retrieval. In this view, the current study aims to retrospectively compare surgical outcomes in women that underwent laparoscopic myomectomy with subsequent power morcellation (before the issuing of the abovementioned Safety Communication by the Food and Drug Administration) or transvaginal extraction (after the issuing of the abovementioned Safety Communication by the Food and Drug Administration) of the surgical specimens.

NCT ID: NCT03550703 Recruiting - Leiomyoma Clinical Trials

Open Label Immunotherapy of Myoma

V3-myoma
Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches up to 80%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.

NCT ID: NCT03535610 Completed - Uterine Leiomyoma Clinical Trials

Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

EMBOSOFT I
Start date: August 13, 2018
Phase: N/A
Study type: Interventional

To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).

NCT ID: NCT03533907 Completed - Infertility, Female Clinical Trials

Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate.

Start date: November 1, 2013
Phase:
Study type: Observational

The investigators analyzed a group of infertile women treated with Ulipristal Acetate (UA) for uterine fibroids at the Humanitas Fertility Center. All the patients' data were extracted from the Fertility Center external-audit-anonymized electronic research query system.