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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

Advance Provision of Medication Abortion

Phase 4
Withdrawn
Conditions
Early Abortion
Interventions
Drug: Mifeprex® (Mifepristone 200 mg)
Diagnostic Test: AccuHome® Pregnancy OTC Test
First Posted Date
2019-02-04
Last Posted Date
2019-05-30
Lead Sponsor
University of California, San Francisco
Registration Number
NCT03829696

Ulipristal Acetate for Cervical Preparation

Early Phase 1
Completed
Conditions
Termination of Pregnancy
Interventions
First Posted Date
2019-01-14
Last Posted Date
2020-07-01
Lead Sponsor
Stanford University
Target Recruit Count
13
Registration Number
NCT03802149
Locations
🇺🇸

Stanford Health Care, Stanford, California, United States

Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg

Phase 4
Conditions
Contraception
Interventions
First Posted Date
2018-05-25
Last Posted Date
2019-10-08
Lead Sponsor
Health Decisions
Target Recruit Count
1200
Registration Number
NCT03537768
Locations
🇺🇸

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

🇺🇸

University of Pittsburgh/Magee Women's Hospital, Pittsburgh, Pennsylvania, United States

🇺🇸

Oregon Health Science University, Portland, Oregon, United States

and more 15 locations

On Demand Contraception: Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility

Phase 1
Completed
Conditions
Contraception
Interventions
First Posted Date
2017-11-27
Last Posted Date
2019-06-25
Lead Sponsor
Stanford University
Target Recruit Count
12
Registration Number
NCT03354117
Locations
🇺🇸

Stanford University, Stanford, California, United States

Impact of Esmya on Fertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques

Completed
Conditions
Infertility, Female
Fibroid Uterus
First Posted Date
2017-11-21
Last Posted Date
2019-01-09
Lead Sponsor
ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO
Target Recruit Count
127
Registration Number
NCT03349190
Locations
🇫🇷

Chu Angers, Angers, France

🇫🇷

Centre Hospitalier Intercommunal Creteil, Créteil, France

🇫🇷

Chu Dijon, Dijon, France

and more 20 locations

Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned

Phase 1
Terminated
Conditions
Leiomyoma
Interventions
Drug: Vilaprisan, BAY1002670
First Posted Date
2017-11-17
Last Posted Date
2021-01-06
Lead Sponsor
Bayer
Target Recruit Count
10
Registration Number
NCT03342859
Locations
🇬🇧

Edinburgh Royal Infirmary/ NHS Lothian, Edinburgh, United Kingdom

Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis

Phase 4
Withdrawn
Conditions
Adenomyosis
Heavy Uterine Bleeding
Dysmenorrhea
Interventions
First Posted Date
2017-10-30
Last Posted Date
2018-02-08
Lead Sponsor
Vanderbilt University Medical Center
Registration Number
NCT03325868
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Study of the Safety and Efficacy of Ulipristal Acetate (UPA) Used Daily as a Contraceptive

Phase 2
Suspended
Conditions
Contraception
Healthy Female
Interventions
First Posted Date
2017-09-28
Last Posted Date
2019-10-09
Lead Sponsor
Health Decisions
Target Recruit Count
300
Registration Number
NCT03296098
Locations
🇺🇸

Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States

🇺🇸

New York University, School of Medicine, New York, New York, United States

🇺🇸

Columbia University, New York, New York, United States

and more 15 locations

A proof-of Concept, Randomized 3-month Study to Evaluate the Effects of Three Contraceptive Intrauterine Systems Delivering Copper and a Daily Dose of 5, 20 or 40 μg of Ulipristal Acetate (UPA)

First Posted Date
2017-07-26
Last Posted Date
2017-08-15
Lead Sponsor
Population Council
Target Recruit Count
30
Registration Number
NCT03230539
Locations
🇩🇴

Profamilia, Santo Domingo, Dominican Republic

Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena

Phase 4
Conditions
Heavy Menstrual Bleeding
Abnormal Bleeding
Interventions
First Posted Date
2017-06-14
Last Posted Date
2018-05-03
Lead Sponsor
University of Campinas, Brazil
Target Recruit Count
32
Registration Number
NCT03186586
Locations
🇧🇷

University of Campinas, Campinas, SP, Brazil

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