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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

A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

Phase 3
Completed
Conditions
Leiomyoma
Uterine Hemorrhage
Interventions
First Posted Date
2014-05-26
Last Posted Date
2019-04-30
Lead Sponsor
Allergan
Target Recruit Count
157
Registration Number
NCT02147197
Locations
🇺🇸

Watson Investigational Site 103, Atlanta, Georgia, United States

🇺🇸

Watson Investigational Site 115, Lakewood, Colorado, United States

🇺🇸

Watson Investigational Site 111, Augusta, Georgia, United States

and more 25 locations

A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas

Phase 3
Completed
Conditions
Uterine Hemorrhage
Leiomyoma
Interventions
First Posted Date
2014-05-26
Last Posted Date
2019-06-04
Lead Sponsor
Allergan
Target Recruit Count
432
Registration Number
NCT02147158
Locations
🇺🇸

Watson Investigational Site 108, Las Vegas, Nevada, United States

🇺🇸

Watson Investigational Site 107, Las Vegas, Nevada, United States

🇺🇸

Watson investigational site 142, Pittsburgh, Pennsylvania, United States

and more 54 locations

Efficacy Study of Two Continuous Regimens of Oral Daily 5 mg or 10 mg of Ulipristal Acetate (UPA), Versus a Dose of 5.0mg UPA for 24/4 Days

Phase 2
Completed
Conditions
Focus: Estrogen-free Oral Contraception
Interventions
First Posted Date
2013-10-01
Last Posted Date
2016-02-22
Lead Sponsor
Health Decisions
Target Recruit Count
180
Registration Number
NCT01953679
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

🇺🇸

University of Colorado - Denver Anschutz Medical Campus, Aurora, Colorado, United States

🇺🇸

Eastern Virgina Medical School, Norfolk, Virginia, United States

and more 7 locations

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Phase 3
Completed
Conditions
Uterine Fibroids
Interventions
First Posted Date
2012-07-17
Last Posted Date
2016-01-08
Lead Sponsor
PregLem SA
Target Recruit Count
64
Registration Number
NCT01642472
Locations
🇦🇹

Medical University Vienna, Vienna, Austria

🇧🇪

Cliniques Universitaires Saint-Luc, Gynécologie-Obstétrique,, Brussels, Belgium

🇧🇪

CHR de la Citadelle, Liège, Belgium

and more 13 locations

Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella

Completed
Conditions
Emergency Contraception
Interventions
First Posted Date
2012-04-03
Last Posted Date
2019-10-21
Lead Sponsor
HRA Pharma
Target Recruit Count
98
Registration Number
NCT01569737
Locations
🇺🇸

Planned Parenthood Federation of America, Inc, New York, New York, United States

Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.

Phase 4
Completed
Conditions
Emergency Contraception
Interventions
First Posted Date
2012-04-02
Last Posted Date
2013-06-13
Lead Sponsor
HRA Pharma
Target Recruit Count
76
Registration Number
NCT01569113
Locations
🇳🇱

Dinox, Groningen, Netherlands

🇬🇧

Chalmers Sexual Health Clinic, Edinburgh, Scotland, United Kingdom

🇸🇪

Karolinska University Hospital Solna, Stockholm, Sweden

Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma

Phase 3
Withdrawn
Conditions
Leiomyomas
Interventions
First Posted Date
2012-03-13
Last Posted Date
2013-02-07
Lead Sponsor
Watson Pharmaceuticals
Registration Number
NCT01553123
Locations
🇺🇸

Discovery Clinical Trials - Genesis Health Central Women's Care, Dallas, Texas, United States

🇺🇸

Lawrence Obstetrics-Gynecology Clinical Research, Lawrenceville, New Jersey, United States

🇺🇸

Columbus Center for Women's Health Research, Columbus, Ohio, United States

and more 43 locations

Levonorgestrel Intrauterine System For Emergency Contraception

Not Applicable
Completed
Conditions
Pregnancy; Accident
Pregnancy, Unplanned
Interventions
Device: levonorgestrel IUS
First Posted Date
2012-02-27
Last Posted Date
2024-02-20
Lead Sponsor
Planned Parenthood of the St. Louis Region and Southwest Missouri
Target Recruit Count
274
Registration Number
NCT01539720
Locations
🇺🇸

Atlanta Women's Center, Atlanta, Georgia, United States

🇺🇸

Indiana University School of Medicine, Indianapolis, Indiana, United States

🇺🇸

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

CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women

Early Phase 1
Withdrawn
Conditions
Urogenital Abnormalities
First Posted Date
2011-12-16
Last Posted Date
2019-12-17
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Registration Number
NCT01493791

Ulipristal Acetate on Progesterone Levels and Glycodelin-A Endometrial Pattern

Not Applicable
Conditions
Infertility
Interventions
First Posted Date
2011-07-12
Last Posted Date
2011-07-20
Lead Sponsor
Programa de Asistencia Reproductiva de Rosario
Target Recruit Count
16
Registration Number
NCT01391845
Locations
🇦🇷

PROAR (Programa de Asistencia Reproductiva de Rosario, Rosario, Santa Fe, Argentina

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