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Clinical trials for Ulipristal acetate

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    15 result(s) found for: Ulipristal acetate. Displaying page 1 of 1.
    EudraCT Number: 2014-000964-16 Sponsor Protocol Number: 1311-BCN-138-DG Start Date*: 2015-03-30
    Sponsor Name:IVI Valencia
    Full Title: Uterine fibroids: Impact of ulipristal acetate 10 mg on ART results.
    Medical condition: Uterine Fibroids and Assisted Reproduction
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (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: 2015-001716-36 Sponsor Protocol Number: 6100 Start Date*: 2015-08-03
    Sponsor Name:HÔPITAUX UNIVERSITAIRES DE STRASBOURG
    Full Title: LONG TERM EFFECT AND TOLERANCE OF ULIPRISTAL ACETATE IN Charcot-Marie-TOOTH DISEASE TYPE 1A (UPACOMT)
    Medical condition: Charcot-Marie-Tooth disease type 1A
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10008414 Charcot-Marie-Tooth disease LLT
    Population Age: Adults Gender: Male
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001587-19 Sponsor Protocol Number: UHSM0315 Start Date*: 2015-07-15
    Sponsor Name:Manchester University NHS Foundation Trust
    Full Title: A pilot prevention study of the effects of the anti-progestin Ulipristal Acetate (UA) on surrogate markers of breast cancer risk
    Medical condition: We seek to investigate the breast cancer risk reducing properties of ulipristal acetate
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022891 - Investigations 10004746 Biopsy breast normal PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    20.0 10022891 - Investigations 10071224 Breast scan PT
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-001719-19 Sponsor Protocol Number: 2016:1 Start Date*: 2016-07-25
    Sponsor Name:Uppsala University
    Full Title: Selecitve progesterone receptor modulators for treatment of premenstrual dysphoric disorder. A randomized, double-blind, placebo controlled study.
    Medical condition: Premenstrual dysphoric disorder
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-005494-53 Sponsor Protocol Number: Start Date*: 2014-10-16
    Sponsor Name:Norfolk and Norwich University Hospitals NHS Foundation Trust
    Full Title: A Study of the Histopathological Changes within Ectopic Endometrial Tissue, in Subjects with Known Pelvic Endometriosis Following Treatment with Ulipristal Acetate, a Selective Progesterone Recepto...
    Medical condition: Endometriosis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10042613 - Surgical and medical procedures 10057902 Endometriosis ablation PT
    17.0 10038604 - Reproductive system and breast disorders 10014785 Endometriosis of pelvic peritoneum LLT
    17.0 10038604 - Reproductive system and breast disorders 10014788 Endometriosis related pain LLT
    17.0 10042613 - Surgical and medical procedures 10014779 Endometriosis in pelvis, excision LLT
    17.0 10038604 - Reproductive system and breast disorders 10014778 Endometriosis PT
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2011-005573-23 Sponsor Protocol Number: 2914-015 Start Date*: 2012-02-20
    Sponsor Name:Laboratoire HRA Pharma
    Full Title: A prospective, randomized, double-blind parallel-arm, placebo-controlled study to assess the effects on ovarian activity of a combined oral contraceptive pill when preceded by the intake of ellaOne...
    Medical condition: Contraception
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed) NL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-002283-41 Sponsor Protocol Number: 151032-002 Start Date*: 2017-09-11
    Sponsor Name:HRA Pharma
    Full Title: A prospective, randomized, parallel-group study to assess the effects on ovarian activity of ellaOne (ulipristal acetate 30 mg single dose) taken after three consecutive days of missed combined ora...
    Medical condition: Emergency contraception
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    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: 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: 2012-000036-26 Sponsor Protocol Number: PGL11-006 Start Date*: 2012-12-20
    Sponsor Name:PregLem S.A.
    Full Title: A Phase III, multicentre, randomized, double-blind clinical study, investigating the efficacy and safety of repeated 12-week courses of daily 5mg or 10mg doses of PGL4001 for the long-term manageme...
    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 ...
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10046801 Uterine myoma LLT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed) BE (Completed) HU (Completed) GB (Completed) CZ (Completed) LV (Completed) LT (Completed) PL (Prematurely Ended) IT (Completed)
    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: 2014-003408-65 Sponsor Protocol Number: Start Date*: 2016-08-26
    Sponsor Name:University of Edinburgh [...]
    1. University of Edinburgh
    2. NHS Lothian
    Full Title: Ulipristal acetate versus conventional management of heavy menstrual bleeding (HMB; including uterine fibroids): a randomised controlled trial and exploration of mechanism of action (UCON trial)
    Medical condition: Heavy menstrual bleeding
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10046784 Uterine fibroids LLT
    18.0 10038604 - Reproductive system and breast disorders 10027313 Menorrhagia PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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