MedPath

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

A Study to Evaluate the Effect of a Contraceptive Vaginal Ring Delivering Ulipristal Acetate Combined With a Single or Repeated Levonorgestrel on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women

Phase 1
Conditions
Ovulation Inhibition
Interventions
First Posted Date
2015-05-22
Last Posted Date
2017-08-15
Lead Sponsor
Population Council
Target Recruit Count
19
Registration Number
NCT02451826
Locations
🇩🇴

Profamilia, Santo Domingo, Dominican Republic

Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

Phase 4
Conditions
Uterine Fibroids
Interventions
Procedure: operative hysteroscopy
First Posted Date
2015-05-12
Last Posted Date
2016-03-09
Lead Sponsor
University of Cagliari
Target Recruit Count
50
Registration Number
NCT02440750

Ulipristal Acetate 10 mg and Asisted Reproduction

Phase 3
Terminated
Conditions
Intramural Fibroids
Uterine Fibroids
Interventions
First Posted Date
2015-04-24
Last Posted Date
2020-10-14
Lead Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Target Recruit Count
2
Registration Number
NCT02425878
Locations
🇪🇸

IVI Valencia, Valencia, Spain

Breast Cancer - Anti-Progestin Prevention Study 1

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2015-04-03
Last Posted Date
2023-05-06
Lead Sponsor
Manchester University NHS Foundation Trust
Target Recruit Count
24
Registration Number
NCT02408770
Locations
🇬🇧

University Hospitals of South Manchester, Manchester, United Kingdom

The Effect of Ulipristal Acetate (UPA) on Women Ovarian Reserve

Phase 4
Conditions
Infertility
Interventions
First Posted Date
2015-02-12
Last Posted Date
2016-11-18
Lead Sponsor
University Magna Graecia
Target Recruit Count
73
Registration Number
NCT02361892
Locations
🇮🇹

Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy

Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas

Phase 4
Conditions
Fibroid
Interventions
First Posted Date
2015-02-12
Last Posted Date
2016-11-18
Lead Sponsor
University Magna Graecia
Target Recruit Count
42
Registration Number
NCT02361905
Locations
🇮🇹

Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy

Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma

Phase 4
Conditions
Fibroid
Interventions
First Posted Date
2015-02-12
Last Posted Date
2016-11-18
Lead Sponsor
University Magna Graecia
Target Recruit Count
146
Registration Number
NCT02361879
Locations
🇮🇹

Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy

Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation

Phase 4
Conditions
Fibroid
Interventions
First Posted Date
2015-02-06
Last Posted Date
2016-11-18
Lead Sponsor
University Magna Graecia
Target Recruit Count
110
Registration Number
NCT02357563
Locations
🇮🇹

Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy

Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy

Phase 4
Conditions
Fibroids
Interventions
Drug: GnRHa
First Posted Date
2014-11-11
Last Posted Date
2016-11-03
Lead Sponsor
Amsterdam UMC, location VUmc
Target Recruit Count
100
Registration Number
NCT02288130
Locations
🇳🇱

Flevoziekenhuis, Almere, Netherlands

🇳🇱

Onze Lieve Vrouwen Gasthuis, Amsterdam, Netherlands

🇳🇱

Sint Lucas Andreas Ziekenhuis, Amsterdam, Netherlands

and more 6 locations

Ulipristal for Endometriosis-related Pelvic Pain

Phase 4
Completed
Conditions
Endometriosis
Interventions
First Posted Date
2014-08-11
Last Posted Date
2024-05-16
Lead Sponsor
Northwestern University
Target Recruit Count
1
Registration Number
NCT02213081
Locations
🇺🇸

Northwestern University, Prentice Women's Hospital, Chicago, Illinois, United States

© Copyright 2025. All Rights Reserved by MedPath