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Clinical trials for Uterine Leiomyoma

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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    26 result(s) found for: Uterine Leiomyoma. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2013-003945-40 Sponsor Protocol Number: BAY1002670/15788 Start Date*: 2014-05-07
    Sponsor Name:Bayer HealthCare AG
    Full Title: A randomized, parallel-group, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of different doses of BAY 1002670 in subjects with uterine fibroids over 3 months
    Medical condition: Women, 18 to 50 years old, with uterine fibroids documented by transvaginal or abdominal ultrasound at screening with at least 1 uterine fibroid with largest diameter >=3.0 cm and heavy menstrual b...
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10046784 Uterine fibroids LLT
    16.1 100000004864 10016628 Fibroids LLT
    16.1 100000004864 10022794 Intramural leiomyoma of uterus LLT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed) FI (Completed) NO (Completed) HU (Completed) CZ (Completed) BE (Completed) ES (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2017-005022-38 Sponsor Protocol Number: T366/2017 Start Date*: 2018-06-13
    Sponsor Name:Turku University Hospital
    Full Title: Oxytocin in mr guided focused ultrasound treatment (MRI-HIFU)
    Medical condition: women with uterine fibroids or adenomyosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10016628 Fibroids LLT
    20.0 10038604 - Reproductive system and breast disorders 10056268 Adenomyosis PT
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002997-38 Sponsor Protocol Number: BAY1002670/15787 Start Date*: 2018-01-10
    Sponsor Name:Bayer AG
    Full Title: A randomized, parallel-group, double-blind and open-label, placebo-controlled, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids
    Medical condition: Leiomyoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10016628 Fibroids LLT
    21.1 100000004864 10046784 Uterine fibroids LLT
    21.1 100000004864 10022794 Intramural leiomyoma of uterus LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-019810-26 Sponsor Protocol Number: 1968 Start Date*: 2011-09-09
    Sponsor Name:King's College Hospital Foundtion NHS Trust
    Full Title: A randomised controlled trial to investigate the effects of the use of pre-operative GnRH analogue and intra-operative mechanical tourniquet for myomectomy on surgical blood loss, future fertility ...
    Medical condition: Uterine Fiboids
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10046784 Uterine fibroids LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-005641-19 Sponsor Protocol Number: ENG K001 GF / EC 406 Start Date*: Information not available in EudraCT
    Sponsor Name:Takeda Pharma GmbH
    Full Title: 3 Months, Open-Label, Parallel-Group Study of the Pharmacodynamics, Pharmacokinetics and Safety of TAP-144SR 1-month Depot Gelatin-Free vs. Gelatin-Containing Formulation in Female Patients with Ut...
    Medical condition: Uterine fibroids (Uterus myomatosus)
    Disease: Version SOC Term Classification Code Term Level
    8.0 10046784 LLT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004822-41 Sponsor Protocol Number: BAY1002670/16953 Start Date*: 2017-07-13
    Sponsor Name:Bayer AG
    Full Title: An open-label, parallel-group, randomized, multicenter study to assess the safety and efficacy of vilaprisan in subjects with uterine fibroids versus standard of care
    Medical condition: Women, 18 years or older, diagnosis of uterine fibroid(s) documented by ultrasound at screening and/or during a uterine preserving procedure within 3 months prior to screening in subjects with high...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10016628 Fibroids LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed) FI (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2021-000452-19 Sponsor Protocol Number: 20-OBE2109-007 Start Date*: 2021-04-29
    Sponsor Name:ObsEva S.A.
    Full Title: A long-term follow-up study to assess bone mineral density in subjects with uterine fibroids completing the Phase 3 studies of linzagolix, PRIMROSE 1 or PRIMROSE 2
    Medical condition: Treatment of heavy menstrual bleeding associated with uterine fibroids.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10046784 Uterine fibroids LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Completed) PL (Completed) LV (Completed) BG (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2008-001804-22 Sponsor Protocol Number: PGL07-021 Start Date*: 2008-10-16
    Sponsor Name:PregLem S.A.
    Full Title: A Phase III, randomized, parallel group, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of PGL4001 (ulipristal) versus placebo for pre-operative treatment of...
    Medical condition: Uterine myoma are benign, monoclonal, hormone sensitive, smooth muscle tumors of the uterus. It is the most common tumor of the female reproductive tract in pre-menopausal women and mostly asympto...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10046801 Uterine myoma LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed) HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-001805-40 Sponsor Protocol Number: PGL07-022 Start Date*: 2008-07-28
    Sponsor Name:PregLem S.A.
    Full Title: A Phase III, randomised, parallel group, double-blind, double-dummy, active comparator -controlled, multi-center study to assess the efficacy and safety of PGL4001 (ulipristal) versus GnRH-agonist ...
    Medical condition: Uterine myomas are benign, monoclonal, hormone sensitive, smooth muscle tumors of the uterus. It is the most common tumor of the female reproductive tract in pre-menopausal women and mostly asympt...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10046801 Uterine myoma LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) ES (Completed) AT (Completed) FR (Completed) IT (Completed) PL (Completed) DE (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004221-41 Sponsor Protocol Number: BAY1002670/17541 Start Date*: Information not available in EudraCT
    Sponsor Name:Bayer HealthCare AG
    Full Title: A randomized, parallel-group, double-blind placebo-controlled and open label active-controlled, multi-center study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids
    Medical condition: Leiomyoma
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10046784 Uterine fibroids LLT
    17.1 100000004864 10016628 Fibroids LLT
    17.1 100000004864 10022794 Intramural leiomyoma of uterus LLT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed) DE (Completed) PT (Completed) NL (Completed) GB (Completed) FI (Completed) AT (Completed) CZ (Completed) HU (Completed) LT (Completed) BE (Completed) ES (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-005120-16 Sponsor Protocol Number: 62638 Start Date*: 2018-11-02
    Sponsor Name:Amsterdam UMC, Location VUmc
    Full Title: Ulipristal versus standard surgical treatment in symptomatic uterine fibroids
    Medical condition: Uterine fibroids are very common during reproductive years in women. Minimally invasive treatments are emerging. Myomectomy is the gold standard, preferably laparoscpically, because it removes the ...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10046784 Uterine fibroids LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-000082-37 Sponsor Protocol Number: M12-813 Start Date*: 2013-12-23
    Sponsor Name:Abbvie Deutschland GmbH & Co. KG
    Full Title: A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids
    Medical condition: Heavy menstrual bleeding associated with uterine fibroids
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10046784 Uterine fibroids LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-004425-41 Sponsor Protocol Number: ESN364-UF-02 Start Date*: 2015-01-21
    Sponsor Name:Euroscreen S.A
    Full Title: A Phase IIa, Double-Blind, Placebo-Controlled, Study of ESN364 Administered for 12 Weeks to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Women Presenting With ...
    Medical condition: Uterine Fibroids
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10046784 Uterine fibroids LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001465-33 Sponsor Protocol Number: PGL11-024 Start Date*: 2012-07-09
    Sponsor Name:PregLem S.A.
    Full Title: A Phase III, multicentre, extension study investigating the efficacy and safety of repeated intermittent 3-month courses of open-label administration of ulipristal acetate, in subjects with symp...
    Medical condition: Uterine myomas are benign, monoclonal, hormone-sensitive, smooth muscle tumours of the uterus. They are the most common tumour of the female reproductive tract in pre-menopausal women and mostly a...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10046801 Uterine myoma LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) AT (Completed) ES (Ongoing) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-019497-32 Sponsor Protocol Number: PGL09-027 Start Date*: 2010-11-09
    Sponsor Name:PregLem S.A.
    Full Title: A Phase III, multicentre, clinical study investigating the efficacy and safety of three successive periods of 3-month open-label PGL4001 treatment, each followed by ten days of double-blind treatme...
    Medical condition: Uterine myomas are benign, monoclonal, hormone-sensitive, smooth muscle tumours of the uterus. They are the most common tumour of the female reproductive tract in pre-menopausal women and mostly as...
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10046801 Uterine myoma LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) PL (Completed) AT (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-002832-15 Sponsor Protocol Number: 49916 Start Date*: 2014-12-17
    Sponsor Name:VU university medical center
    Full Title: Ulipristal versus Gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy: a double blind randomized controlled trial
    Medical condition: Uterine fibroids are very common during reproductive years in women. Minimally invasive treatments are emerging. Myomectomy is the gold standard which removes the fibroids entirely, preferably lapa...
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10046784 Uterine fibroids LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-017222-39 Sponsor Protocol Number: MIFLIT09 Start Date*: 2010-09-09
    Sponsor Name:Laboratorios Litaphar S.A.
    Full Title: Ensayo clínico aleatorizado, doble ciego, doble enmascarado, multicéntrico para evaluar la eficacia y seguridad de 5 mg de mifepristona oral comparado con triptorelina IM administrados durante 4 me...
    Medical condition: fibroma uterino
    Disease: Version SOC Term Classification Code Term Level
    9 10046787 Uterine fibromyoma LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002855-48 Sponsor Protocol Number: BAY1002670/15789 Start Date*: 2017-07-12
    Sponsor Name:Bayer AG
    Full Title: A randomized, parallel-group, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids
    Medical condition: Leiomyoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10046784 Uterine fibroids LLT
    20.0 100000004864 10016628 Fibroids LLT
    20.0 100000004864 10022794 Intramural leiomyoma of uterus LLT
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed) SE (Completed) CZ (Completed) HU (Prematurely Ended) FI (Completed) AT (Prematurely Ended) NO (Prematurely Ended) DE (Completed) ES (Prematurely Ended) GB (GB - no longer in EU/EEA) DK (Completed) BE (Completed) SK (Completed) LT (Completed) NL (Prematurely Ended) PT (Completed) BG (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-018999-25 Sponsor Protocol Number: PGL09-026 Start Date*: 2010-07-13
    Sponsor Name:PregLem S.A.
    Full Title: Estudio multicéntrico de fase III para investigar la eficacia y la seguridad del tratamiento abierto de 3 meses con PGL4001, seguido de un periodo aleatorizado, doble ciego y controlado con placebo...
    Medical condition: Los miomas uterinos son tumores benignos, monoclonales y sensibles a las hormonas, del músculo liso del útero. Son los miomas que aparecen con más frecuencia en el aparato reproductor femenino en l...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10046801 Uterine myoma LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed) PL (Completed) AT (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003310-74 Sponsor Protocol Number: MVT-601-3003 Start Date*: 2018-03-21
    Sponsor Name:Myovant Sciences GmbH
    Full Title: LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered with Low-Dose Estradiol and Norethindrone Ace...
    Medical condition: heavy menstrual bleeding associated with uterine fibroids
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004872 10027331 Menstrual flow altered LLT
    21.1 100000004864 10046783 Uterine fibroid LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) BE (Completed) CZ (Completed) PL (Prematurely Ended) IT (Completed)
    Trial results: (No results available)
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