| Esmya (ulipristal acetate) / ASKA Pharma, Gedeon Richter, AbbVie, Perrigo Company |
NCT01569113 / 2011-005573-23: Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo. |
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| Completed | 4 | 76 | Europe | Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon), ellaOne + Microgynon 30, placebo + ethinylestradiol/levonorgestrel, Microgynon 30 | HRA Pharma | Emergency Contraception | 08/12 | 08/12 | | |
2014-002832-15: Ulipristal versus Gonadotropin-releasing hormone agonists prior to laparoscopic fibroid removal: a double blind randomized controlled trial Ulipristal versus Gonadotropine-releasing hormoon agonists voorafgaand aan laparoscopische myoom verwijdering: een dubbelblind gerandomiseerd onderzoek |
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| Completed | 4 | 99 | Europe | Tablet, Powder and solvent for suspension for injection, Esmya, Lucrin | VU university medical center, Gedeon Richter | 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 laparoscopically because of a faster recovery and cosmetical benefits, although the succes of a laparoscopic approach is dependent on the size of the fibroid(s) and the difficulty of dissection. Myomen van de uterus komen veel voor. Het toepassen van een myoomenucleatie is de gouden standaard: alleen hiermee worden het myoom (de myomen) volledig verwijderd. Minimaal invasieve behandelingen worden steeds vaker toegepast. De laparoscopische myoomenucleatie wordt bij voorkeur uitgevoerd ivm het voordeel voor de patient ten aanzien van herstel en cosmetisch resultaat. Het succes van laparoscopisch opereren wordt echter bepaald door de grootte van het myoom en het chirurgische klievingsvlak., Uterine fibroids are very common. Sometimes removal is necessary, preferably by laparoscopy, although this is only possible when the fibroids are not too big. Myomen (vleesbomen) van de baarmoeder komen veel voor. Soms is het noodzakelijk om deze myomen te verwijderen, bij voorkeur met een kijkoperatie, maar dan kan alleen als de myomen niet te groot zijn., Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | | | | |
| Completed | 4 | 34 | US | LNG-EC, Levonorgestrel (LNG) emergency contraceptive (EC), Next Choice One Dose, UPA-EC, Ulipristal acetate (UPA) emergency contraceptive (EC), ella | Columbia University | Contraception | 12/15 | 02/17 | | |
NCT02440750: Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women |
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| Unknown status | 4 | 50 | NA | operative hysteroscopy, Dienogest, Visanne, Ulipristal acetate, Esmya | University of Cagliari | Uterine Fibroids | 04/17 | 06/17 | | |
NCT02213081: Ulipristal for Endometriosis-related Pelvic Pain |
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| Completed | 4 | 1 | US | Ulipristal, Ulipristal Acetate, Ella | Northwestern University | Endometriosis | 11/16 | 12/16 | | |
| Unknown status | 4 | 73 | Europe | ulipristal acetate, Esmya | University Magna Graecia | Infertility | 06/17 | 09/17 | | |
NCT02577601: Impact of Combined Hormonal Contraceptives on UPA |
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| Completed | 4 | 36 | US | Ulipristal Acetate, UPA, Ella, Levonorgestrel (LNG)/Ethinyl estradiol birth control pill, portia (generic), birth control pills | Oregon Health and Science University, Society of Family Planning | Contraception | 06/17 | 06/17 | | |
| Unknown status | 4 | 100 | Europe | GnRHa, Lucrin, Ulipristal, Esmya | Amsterdam UMC, location VUmc | Fibroids | 07/17 | 11/17 | | |
NCT02361905: Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas |
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| Unknown status | 4 | 42 | Europe | ulipristal acetate, Esmya, Leuprolide acetate, Enantone 11.25 | University Magna Graecia | Fibroid | 09/17 | 09/17 | | |
NCT02357563: Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation |
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| Unknown status | 4 | 110 | Europe | ulipristal acetate, Esmya, Leuprolide acetate, Enantone 11.25 | University Magna Graecia | Fibroid | 09/17 | 09/17 | | |
NCT02361879: Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma |
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| Unknown status | 4 | 146 | Europe | ulipristal acetate, Esmya, Leuprolide acetate, Enantone 11.25 | University Magna Graecia | Fibroid | 09/17 | 09/17 | | |
NCT02601196: IVF Outcome Following Treatment With Ulipristal Acetate for Myomatous Uterus After at Least One IVF Failure |
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| Unknown status | 4 | 20 | NA | Ulipristal acetate | Sheba Medical Center | Women With Leiomyoma After at Least One Unsuccessful IVF Treatment | 01/18 | 01/18 | | |
| Completed | 4 | 40 | Europe | ellaOne, Levora, Tablet, ellaOne, Levora | HRA Pharma, HRA Pharma | Emergency contraception, Emergency contraception, Body processes [G] - Metabolic Phenomena [G03] | | | | |
NCT03186586: Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena |
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| Unknown status | 4 | 32 | RoW | Ulipristal acetate, Placebo | University of Campinas, Brazil | Heavy Menstrual Bleeding, Abnormal Bleeding | 07/18 | 07/18 | | |
2017-005120-16: Ulipristal versus surgery for symptomatic uterine fibroids Ulipristal (een medicijn) versus operatieve behandeling bij symptomatische vleesbomen in de baarmoeder. |
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| Not yet recruiting | 4 | 179 | Europe | Esmya, Tablet, Esmya | Amsterdam UMC, Location VUmc, ZonMW | 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 fibroids entirely. Ulipristal, a selective progesterone receptor modulator, was introduced in 2012 as a new revolutionary (long-term) treatment for symptomatic uterine fibroids. It claims to make invasive treatment unnecessary. Myomen van de uterus komen veel voor. (Laparoscopische) myomectomie is de gouden standaard, gezien het feit dat de myomen in geheel wordt verwijderd. Ulipristal, een selectieve progesteron receptor modulator, is in 2012 op de markt gekomen als een nieuwe, revolutionaire (lange termijn) behandeling voor symptomatische uterine myomen. Het claimt invasieve behandeling te kunnen voorkomen., Uterine fibroids are very common. Sometimes surgical removal is necessary. However, ulipristal, a new medicine for treatment of symptomatic fibroids, claims to make invasive treatment unnecessary. Myomen (vleesbomen) van de baarmoeder komen veel voor. Soms is chirugische verwijdering noodzakelijk. Ulipristal is een nieuw medicijn dat beweert chirurgische behandeling te kunnen voorkomen., Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | | | | |
NCT03325868: Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis |
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| Withdrawn | 4 | 0 | US | Ulipristal Acetate, Fibristal | Vanderbilt University Medical Center | Adenomyosis, Heavy Uterine Bleeding, Dysmenorrhea | 05/19 | 05/19 | | |
NCT04989400: Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion |
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| Completed | 4 | 24 | RoW | Ulipristal Acetate, Misoprostol | Ain Shams University | Induction of Second Trimester Abortion | 10/19 | 01/20 | | |
| Terminated | 4 | 31 | RoW | Ulipristal acetate, Esyma, Placebo pills, Ferrous sulphate, Ferasul, Tranexamic Acid, Transamin | Queen Mary Hospital, Hong Kong | Fibroid | 03/20 | 03/20 | | |
NCT04132349: Ulipristal Acetate in Symptomatic Uterine Fibroid |
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| Terminated | 4 | 25 | RoW | Ulipristal Acetate 5 mg, Esmya | Mỹ Äức Hospital | Uterine Fibroid, Heavy Menstrual Bleeding | 04/20 | 04/20 | | |
NCT03537768: Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg |
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| Terminated | 4 | 532 | US | Ulipristal Acetate, Ella, Levonorgestrel, Plan B, Plan B (double dose) | Kimberly Myer, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Contraception | 04/22 | 04/22 | | |
| Withdrawn | 4 | 0 | NA | Mifeprex® (Mifepristone 200 mg), Misoprostol 800 mcg, ella® (ulipristal acetate emergency contraception 30 mg), AccuHome® Pregnancy OTC Test | University of California, San Francisco | Early Abortion | 01/21 | 01/21 | | |
| Completed | 4 | 70 | RoW | Ulipristal Oral Tablet, Uterine artery embolization | Ain Shams Maternity Hospital | Uterine Fibroid | 03/21 | 03/21 | | |
NCT05674513: Disparities in Emergency Contraceptive Metabolism Dictate Efficacy |
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| Recruiting | 4 | 140 | US | Ulipristal acetate | Oregon Health and Science University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Contraceptive Usage | 12/26 | 12/27 | | |
