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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

Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

Phase 3
Not yet recruiting
Conditions
Contraception
Interventions
First Posted Date
2024-12-11
Last Posted Date
2024-12-27
Lead Sponsor
The University of Hong Kong
Target Recruit Count
980
Registration Number
NCT06727734

Disparities in Emergency Contraceptive Metabolism Dictate Efficacy

Phase 4
Recruiting
Conditions
Contraceptive Usage
Interventions
First Posted Date
2023-01-06
Last Posted Date
2024-08-19
Lead Sponsor
Oregon Health and Science University
Target Recruit Count
140
Registration Number
NCT05674513
Locations
🇺🇸

OHSU, Portland, Oregon, United States

Advance Provision of Postpartum Emergency Contraception and Its Effects on Reproductive Autonomy

Completed
Conditions
Reproductive Issues
Contraception
Contraceptive Usage
Interventions
First Posted Date
2022-03-17
Last Posted Date
2025-04-27
Lead Sponsor
Northwestern University
Target Recruit Count
75
Registration Number
NCT05285605
Locations
🇺🇸

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

Ulipristal Acetate for Use in Early Pregnancy Loss

Phase 2
Completed
Conditions
Non-Viable Pregnancy
Missed Abortion
Anembryonic Pregnancy
Interventions
First Posted Date
2022-02-01
Last Posted Date
2023-06-28
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
3
Registration Number
NCT05216952
Locations
🇺🇸

University of North Carolina, Chapel Hill - Weaver Crossing, Chapel Hill, North Carolina, United States

🇺🇸

University of North Carolina, Chapel Hill - Same Day OBGYN Clinic, Chapel Hill, North Carolina, United States

🇺🇸

University of North Carolina, Chapel Hill - Hillsborough Medical Office Building, Hillsborough, North Carolina, United States

and more 1 locations

Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion

Phase 4
Completed
Conditions
Induction of Second Trimester Abortion
Interventions
First Posted Date
2021-08-04
Last Posted Date
2021-08-04
Lead Sponsor
Ain Shams University
Target Recruit Count
24
Registration Number
NCT04989400
Locations
🇪🇬

Ain SHams Maternity Hospital, Cairo, Abbaseya, Egypt

UA Versus UAE in Treatment of Fibroids

Phase 4
Completed
Conditions
Uterine Fibroid
Interventions
Procedure: Uterine artery embolization
First Posted Date
2021-04-06
Last Posted Date
2021-04-06
Lead Sponsor
Ain Shams Maternity Hospital
Target Recruit Count
70
Registration Number
NCT04832906
Locations
🇪🇬

Ain Shams Maternity Hospital, Cairo, Abbassia, Egypt

Ovarian Function With ENG Implant and UPA Use

Early Phase 1
Completed
Conditions
Contraception
Interventions
First Posted Date
2020-03-02
Last Posted Date
2024-07-12
Lead Sponsor
University of Utah
Target Recruit Count
40
Registration Number
NCT04291001
Locations
🇺🇸

University of Utah, Salt Lake City, Utah, United States

Ulipristal Acetate in Symptomatic Uterine Fibroid

Phase 4
Terminated
Conditions
Uterine Fibroid
Heavy Menstrual Bleeding
Interventions
First Posted Date
2019-10-18
Last Posted Date
2020-04-13
Lead Sponsor
Mỹ Đức Hospital
Target Recruit Count
25
Registration Number
NCT04132349
Locations
🇻🇳

My Duc Hospital, Ho Chi Minh City, Vietnam

Esmya Versus Surgery Before IVF/ICSI

Active, not recruiting
Conditions
Infertility, Female
Surgical Procedure, Unspecified
Fibroid; Uterus Tumor, Complicating Pregnancy
Interventions
First Posted Date
2019-07-23
Last Posted Date
2023-05-16
Lead Sponsor
Universitair Ziekenhuis Brussel
Target Recruit Count
40
Registration Number
NCT04028986
Locations
🇧🇪

Universitair Ziekenhuis UZBrussel, Jette, Brussels, Belgium

Liver Safety Assessment During Ulipristal Acetate Treatment for Uterine Fibroids (LISA)

Terminated
Conditions
Leiomyoma, Uterine
Liver Injury
Treatment Side Effects
Interventions
First Posted Date
2019-07-02
Last Posted Date
2024-05-20
Lead Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Target Recruit Count
30
Registration Number
NCT04004884
Locations
🇪🇸

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

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