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Ulipristal

Generic Name
Ulipristal
Brand Names
Ella, Ellaone, Esmya, ellaOne
Drug Type
Small Molecule
Chemical Formula
C28H35NO3
CAS Number
159811-51-5
Unique Ingredient Identifier
6J5J15Q2X8
Background

Ulipristal is a selective progesterone receptor modulator used for the purposes of emergency contraception (Ella) and for the treatment of uterine fibroids (Fibristal). It is a derivative of 19-norprogesterone and has both antagonistic and partial agonist activity at the progesterone receptor. It also binds to glucocorticoid receptor, however compared to mifepristone (a progesterone receptor antagonist), ulipristal is more tolerable and has lower glucocorticoid activity and better binding affinity.

Ulipristal is currently recommended as first line therapy for emergency contraception, due to improved efficacy and similar side effect profile as compared to the traditional use of levonorgestrel or the Yuzpe regimen. The exact mechanism of action for ulipristal is still currently debated, though there is evidence that it functions by inhibiting ovulation. A recent systematic review proclaimed that the majority of available evidence demonstrates an inhibitory effect on ovulation rather than a post-fertilization effect on the endometrium, which has been heavily debated due to ethical concerns related to abortion (Rosato et al, 2016). Nevertheless, current and ongoing research into the agent's mechanism of action as an emergency contraceptive continue to provide potentially plausible evidence that ulipristal may, in fact, elicit activity on the endometrium that prevents embryo implantation .

Indication

As the product Ella (available in Canada and the US), ulipristal is indicated for use as emergency contraception after unprotected intercourse or possible contraceptive failure when administered within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. As the product Fibristal (available in Canada), ulipristal is indicated for treatment of the signs and symptoms of uterine fibroids in adult women.

Associated Conditions
Moderate Uterine Fibroids, Severe Uterine Fibroids
Associated Therapies
Emergency Contraception

Intervention to End Recurrent Unscheduled Bleeding Trial

Phase 3
Completed
Conditions
Contraception
Bleeding
Interventions
Drug: Placebo oral capsule
First Posted Date
2017-04-18
Last Posted Date
2018-08-31
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
65
Registration Number
NCT03118297
Locations
🇺🇸

Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States

Compare Daily Ulipristal Acetate and Combined Oral Contraceptive Effects on Breast Epithelial Cell Proliferation

Phase 1
Completed
Conditions
Contraception
Interventions
Drug: Combined Oral Contraceptive Pill
First Posted Date
2016-10-04
Last Posted Date
2020-02-07
Lead Sponsor
Columbia University
Target Recruit Count
29
Registration Number
NCT02922127
Locations
🇺🇸

Weill Cornell Medical Center, New York, New York, United States

🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

Ulipristal Use in Chinese Population

Phase 4
Terminated
Conditions
Fibroid
Interventions
First Posted Date
2016-07-07
Last Posted Date
2020-04-09
Lead Sponsor
Queen Mary Hospital, Hong Kong
Target Recruit Count
31
Registration Number
NCT02825719
Locations
🇭🇰

Department of Obstetrics and Gynaecology, Queen Mary Hospital, Hong Kong, Hong Kong

Study of Ulipristal Acetate in Female Patients With Moderately or Severely Impaired Renal Function, Compared With Matched Healthy Female Subjects

Phase 1
Completed
Conditions
Renal Function
Interventions
First Posted Date
2015-12-18
Last Posted Date
2018-02-08
Lead Sponsor
Allergan
Target Recruit Count
19
Registration Number
NCT02634437
Locations
🇺🇸

Division of Clinical Pharmacology, University of Miami, Miami, Florida, United States

🇺🇸

Clinical Pharmacology of Miami, Miami, Florida, United States

🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

and more 2 locations

IVF Outcome Following Treatment With Ulipristal Acetate for Myomatous Uterus After at Least One IVF Failure

Phase 4
Conditions
Women With Leiomyoma After at Least One Unsuccessful IVF Treatment
Interventions
First Posted Date
2015-11-10
Last Posted Date
2016-07-12
Lead Sponsor
Sheba Medical Center
Target Recruit Count
20
Registration Number
NCT02601196

Ulipristal Acetate In Disease Charcot-Marie-Tooth Type of 1A

Phase 2
Terminated
Conditions
CMT1A
Interventions
First Posted Date
2015-11-09
Last Posted Date
2022-07-25
Lead Sponsor
University Hospital, Strasbourg, France
Target Recruit Count
23
Registration Number
NCT02600286
Locations
🇫🇷

Unité de pathologie neuro-musculaire, Paris, France

🇫🇷

Département de Neurologie Centre de Référence des Maladies Neuromusculaires Grand Est (CERNEST) Hôpital de Hautepierre, Strasbourg, France

🇫🇷

Service d'Explorations et pathologies neuro- musculaires, Besançon, France

and more 1 locations

Adenomyosis and Ulipristal Acetate

Phase 2
Completed
Conditions
Adenomyosis
Interventions
First Posted Date
2015-10-27
Last Posted Date
2022-09-27
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
26
Registration Number
NCT02587000
Locations
🇫🇷

AP-HP, Bicêtre Hospital, Le Kremlin Bicêtre, France

Impact of Combined Hormonal Contraceptives on UPA

First Posted Date
2015-10-16
Last Posted Date
2019-11-08
Lead Sponsor
Oregon Health and Science University
Target Recruit Count
36
Registration Number
NCT02577601
Locations
🇺🇸

Oregon Health & Science University, Portland, Oregon, United States

Ulipristal Emergency Contraception Used Before or After Ovulation

Completed
Conditions
Contraception
Interventions
First Posted Date
2015-08-07
Last Posted Date
2018-07-30
Lead Sponsor
The University of Hong Kong
Target Recruit Count
700
Registration Number
NCT02517463

Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids

First Posted Date
2015-06-09
Last Posted Date
2016-11-22
Lead Sponsor
Bayer
Target Recruit Count
120
Registration Number
NCT02465814
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