ulipristal acetate profile

RTI 3021-012: progesterone receptor antagonist [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

ulipristal acetate : A 20-oxo steroid obtained by acetylation of the 17-hydroxy group of (11beta,17alpha)-17-acetyl-11-[4-(dimethylamino)phenyl]-3-oxoestra-4,9-dien-17-ol (ulipristal). A selective progesterone receptor modulator, which is employed as an emergency contraceptive. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

ID Source	ID
PubMed CID	130904
CHEMBL ID	260538
CHEBI ID	71025
SCHEMBL ID	544957
MeSH ID	M0554383

Synonym
rti 3021-012
unii-yf7v70n02b
yf7v70n02b ,
cbd 2914
ulipristal acetate [usan]
19-norpregna-4,9-diene-3,20-dione, 17-(acetyloxy)-11-(4-(dimethylamino)phenyl)-, (11beta)-
17-acetoxy-11-(4-n,n-dimethylaminophenyl)pregna-4,9-diene-3,20-dione
cdb 2914
ella norpregnadiene
ellaone
(11beta)-17-(acetyloxy)-11-(4-(dimethylamino)phenyl)-19-norpregna-4,9-diene-3,20-dione
ella
hrp-2000
pgl-4001
va2914
ulipristal acet
cdb-2914
chebi:71025 ,
CHEMBL260538
ulipristal acetate
[(8s,11r,13s,14s,17r)-17-acetyl-11-(4-dimethylaminophenyl)-13-methyl-3-oxo-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl] acetate
D09687
ulipristal acetate (jan/usan)
ella (tn)
126784-99-4
bdbm50375424
HY-16508
CS-1157
(11.beta.)-17-(acetyloxy)-11-(4-(dimethylamino)phenyl)-19-norpregna-4,9-diene-3,20-dione
ulipristal acetate [mart.]
ulipristal acetate [orange book]
ulipristal acetate [who-dd]
ulipristal acetate [mi]
17.alpha.-acetoxy-11.beta.-(4-dimethylaminophenyl)-19-norpregna-4,9-dien-3,20-dione
ulipristal acetate [vandf]
ulipristal acetate [jan]
(11beta,17alpha)-17-acetyl-11-[4-(dimethylamino)phenyl]-3-oxoestra-4,9-dien-17-yl acetate
17beta-acetyl-11beta-[4-(dimethylamino)phenyl]-3-oxoestra-4,9-dien-17alpha-yl acetate
ulipristal (acetate)
cbd 2914; va 2914; (11b)-17-(acetyloxy)-11-[4-(dimethylamino)phenyl]-19-norpregna-4,9-diene-3,20-dione
SCHEMBL544957
gtpl7460
(8s,11r,13s,14s,17r)-17-acetyl-11-(4-(dimethylamino)phenyl)-13-methyl-3-oxo-2,3,6,7,8,11,12,13,14,15,16,17-dodecahydro-1h-cyclopenta[a]phenanthren-17-yl acetate
esmya
AB01566874_01
DTXSID30155294 ,
4OAR
17-alpha-acetoxy-11-beta-(4-dimethylaminophenyl)-19-norpregna-4,9-dien-3,20-dione
J-005436
AKOS026750526
OOLLAFOLCSJHRE-ZHAKMVSLSA-N
(1r,3as,3bs,10r,11as)-1-acetyl-10-[4-(dimethylamino)phenyl]-11a-methyl-7-oxo-1h,2h,3h,3ah,3bh,4h,5h,7h,8h,9h,10h,11h,11ah-cyclopenta[a]phenanthren-1-yl acetate
AS-73950
C72119
(11b)-17-(acetyloxy)-11-[4-(dimethylamino)phenyl]-19-norpregna-4,9-diene-3,20-dione
ulipristal acetate, >=98% (hplc)
NCGC00378913-02
ta[a]phenanthren-17-yl] acetate
(11alpha,13alpha,17beta)-17-acetyl-11-[4-(dimethylamino)phenyl]-3-oxoestra-4,9-dien-17-yl acetate
[(8s,11r,13s,14s,17r)-17-acetyl-11-[4-(dimethylamino)phenyl]-13-methyl-3-oxo-1,2,6,7,8,11,12,14,15,16-decahydrocyclopen
c17 epi ulipristal acetate
c17 isomer ulipristal acetate; (10s,11s,14s,15s,17r)-14-acetyl-17-[p-(dimethylamino)phenyl]-15-methyl-5-oxotetracyclo[8.7.0.02,7.011,15]heptadeca-1,6-dien-14-yl acetate
U0102
(11beta)-17-(acetyloxy)-11-[4-(dimethylamino)phenyl]-19-norpregna-4,9-diene-3,20-dione
Q975059
BRD-K64381438-001-03-8
CCG-269500
BU161520
EN300-220766
(8s,11r,13s,14s,17r)-17-acetyl-11-(4-(dimethylamino)phenyl)-13-methyl-3-oxo-2,3,6,7,8,11,12,13,14,15,16,17-dodecahydro-1h-cyclopenta[a]phenanthren-17-ylacetate
Z2185283535
ulipristal acetate (mart.)
(11beta,17alpha)-17-acetyl-11-(4-(dimethylamino)phenyl)-3-oxoestra-4,9-dien-17-yl acetate
dtxcid9077785
11beta-(4-(dimethylamino)phenyl)-3,20-dioxo-19-norpregna-4,9-dien-17-yl acetate
logilia
17beta-acetyl-11beta-(4-(dimethylamino)phenyl)-3-oxoestra-4,9-dien-17alpha-yl acetate
17alpha-acetoxy-11beta-(4-dimethylaminophenyl)-19-norpregna-4,9-dien-3,20-dione
11-beta-17-(acetyloxy)-11-(4-(dimethylamino)phenyl)-19-norpregna-4,9-diene-3,20-dione

Research Excerpts

Overview

Ulipristal acetate (ulipristal) is a selective progesterone receptor modulator that has been marketed for daily use in Europe and Canada to reduce symptoms caused by uterine fibroids. It was authorized for surgical pre-treatment in 2012 after the conduct of the PEARL I and II randomized controlled trials.

Excerpt	Reference	Relevance
"Ulipristal acetate (UPA) is a medical treatment for uterine fibroids and was authorized for surgical pre-treatment in 2012 after the conduct of the PEARL I and II randomized controlled trials and for intermittent treatment after the observational PEARL III and IV trials. "	( Evaluation of marketing authorization and clinical implementation of ulipristal acetate for uterine fibroids. Bet, PM; Clark, TJ; de Lange, ME; Hehenkamp, WJK; Huirne, JAF; Middelkoop, MA; Mol, BWJ, 2022)	2.4
"Ulipristal acetate (UPA) is a selective progesterone receptor modulator and is used for the treatment of uterine leiomyoma (a benign tumor). "	( Ulipristal acetate, a selective progesterone receptor modulator, induces cell death via inhibition of STAT3/CCL2 signaling pathway in uterine sarcoma. Cho, YJ; Choi, JJ; Choi, JY; Hwang, JR; Kim, HS; Lee, JW; Ryu, JY; Sa, JK, 2023)	3.8
"Ulipristal acetate (UPA) is an active selective progesterone receptor modulator used as preoperative treatment for uterine myomas."	( Ulipristal Acetate Before Hysteroscopic Myomectomy: A Systematic Review. Barra, F; Caruso, S; Cianci, A; Ciebiera, M; Ferrero, S; Marín-Buck, A; Török, P; Vilos, GA; Vitagliano, A; Vitale, SG, 2020)	2.72
"Ulipristal acetate (ulipristal) is a selective progesterone receptor modulator that has been marketed for daily use in Europe and Canada to reduce symptoms caused by uterine fibroids. "	( An Evaluation of Postmarketing Reports of Serious Idiosyncratic Liver Injury Associated with Ulipristal Acetate for the Treatment of Uterine Fibroids. Avigan, MI; Brinker, A; Dimick-Santos, L; Jones, SC; Kang, S, 2020)	2.22
"Ulipristal acetate is a drug used as emergency contraceptive (30 mg) and for the treatment of moderate to severe symptoms of uterine myomas (5 mg). "	( Pharmacokinetics, toxicological and clinical aspects of ulipristal acetate: insights into the mechanisms implicated in the hepatic toxicity. Dinis-Oliveira, RJ, 2021)	2.31
"Ulipristal acetate (UPA) is a prescription emergency contraceptive pill (ECP). "	( Pharmacy access to Ulipristal acetate in major cities throughout the United States. Bullock, H; Elia, J; Hurwitz, E; Salcedo, J; Shigesato, M; Tschann, M; Wu, YY, 2018)	2.25
"Ulipristal acetate (UPA) is a selective progesterone receptor modulator (PRM), which is used as an emergency contraceptive in women. "	( Characterization of Molecular Changes in Endometrium Associated With Chronic Use of Progesterone Receptor Modulators: Ulipristal Acetate Versus Mifepristone. Bagchi, IC; Bagchi, MK; Bhurke, A; Gemzell-Danielsson, K; Kannan, A; Lalitkumar, PG; Sitruk-Ware, R; Taylor, RN; Williams, ARW, 2018)	2.13
"Ulipristal acetate (UPA), is a selective progesterone-receptor modulator, it decreases fibroid size and reduces menstrual bleeding. "	( Ulipristal acetate for uterine fibroids: 2 years of real world experience in a UK hospital. Irani, S; Pounds, R; Pradhan, P; Woodhead, N, 2018)	3.37
"Ulipristal acetate (UPA) is a selective progesterone receptor modulator, which has been used to treat uterine fibroids. "	( Predictive factor for volume reduction of uterine fibroids after short-term use of ulipristal acetate. Bae, HS; Jung, YW; Kim, MK; Kim, ML; Seong, SJ; Shim, SS; Yun, BS, 2018)	2.15
"Ulipristal acetate (UPA) is a progesterone receptor modulator (PRM) agent that has shown benefits in women with symptomatic uterine fibroids. "	( Sonographic and hysteroscopic endometrial examination in women treated with ulipristal acetate: Exploratory findings at a tertiary referral center. Carmona, F; Gracia, M; Martínez-Zamora, MÁ; Nonell, R; Quintas, L; Rius, M; Ros, C, 2019)	2.19
"Ulipristal acetate is a selective progesterone receptor modulator that acts on progesterone receptors in uterine muscle and endometrium. "	( Pathologic Changes in Uterine Leiomyomas After Extended Treatment With Ulipristal Acetate. Chang, MC; Latta, E, 2020)	2.23
"Ulipristal acetate (UPA) is a selective progesterone receptor modulator used for emergency contraception that has proven to be highly effective in preventing pregnancy when taken up to 120 h after unprotected sexual intercourse. "	( A single post-ovulatory dose of ulipristal acetate impairs post-fertilization events in mice. Bahamondes, L; Cohen, DJ; Cuasnicú, PS; Gómez-Elías, MD; May, M; Munuce, MJ, 2019)	2.24
"Ulipristal acetate (UPA) is a novel Progesterone Receptor Modulator (PRM) and registered for the pre-operative treatment of symptomatic uterine fibroids during 3months. "	( A 39-week oral toxicity study of ulipristal acetate in cynomolgus monkeys. Bergeron, C; Gotteland, JP; Pohl, O; Williams, AR, 2013)	2.11
"Ulipristal acetate (UPA) is a novel selective progesterone receptor modulator for benign gynaecological conditions such as uterine myoma. "	( Ulipristal acetate - safety and pharmacokinetics following multiple doses of 10-50 mg per day. Gotteland, JP; Osterloh, I; Pohl, O, 2013)	3.28
"Ulipristal acetate (UPA) acts as an emergency contraceptive by inhibiting ovulation. "	( Effects of ulipristal acetate on sperm DNA fragmentation during in vitro incubation. Bahamondes, L; Caille, A; Cicaré, J; Ghersevich, S; Munuce, MJ; Zumoffen, C, 2013)	2.22
"Ulipristal acetate (UPA) is a novel selective progesterone receptor modulator for the treatment of benign gynaecological conditions such as uterine myoma. "	( Effects of erythromycin at steady-state concentrations on the pharmacokinetics of ulipristal acetate. Gotteland, JP; Osterloh, I; Pohl, O, 2013)	2.06
"Ulipristal acetate is a selective progesterone receptor modulator that has been demonstrated to be an effective 3-month pre-operative treatment for moderate to severe symptoms of uterine fibroids in adult women of reproductive age. "	( The cost-effectiveness of ulipristal acetate tablets in treating patients with moderate to severe symptoms of uterine fibroids. Ágh, T; Józwiak-Hagymásy, J; Kaló, Z; Kovács, G; László, Á; Merész, G; Nagy, B; Timár, G; Vámossy, I; Vokó, Z, 2014)	2.15
"Ulipristal acetate (UPA) is a therapeutic agent used as an emergency contraceptive agent."	( Ulipristal acetate--a review of the new therapeutic indications and future prospects. Delev, DP, )	2.3
"Ulipristal acetate (UPA) is an emerging medical treatment of fibroids with the potential to be used for long-term treatment."	( The clinical pharmacology and pharmacokinetics of ulipristal acetate for the treatment of uterine fibroids. Gotteland, JP; Pohl, O; Zobrist, RH, 2015)	1.39
"Ulipristal acetate (UA) is a selective progesterone receptor modulator."	( Ulipristal acetate in the management of symptomatic uterine fibroids: facts and pending issues. Pérez-López, FR, 2015)	2.58
"Ulipristal acetate (UPA) is a selective progesterone-receptor modulator (SPRM). "	( Drug safety evaluation of ulipristal acetate in the treatment of uterine fibroids. Bizzarri, N; Candiani, M; Ferrero, S; Leone Roberti Maggiore, U; Scala, C; Tafi, E; Venturini, PL, 2015)	2.16
"Ulipristal acetate (UPA) is a new selective progesterone receptor (PR) modulator used for emergency contraception. "	( Ulipristal Acetate Antagonizes the Inhibitory Effect of Progesterone on Ciliary Beat Frequency and Upregulates Steroid Receptor Expression Levels in Human Fallopian Tubes. Qin, G; Qiu, J; Yan, M; Yuan, J; Zhang, J; Zhao, W; Zhu, Q, 2015)	3.3
"Ulipristal acetate (UPA) is an orally active synthetic selective progesterone receptor modulator (SPRM) characterized by a tissue-specific progesterone antagonist effect that reduces the proliferation of leiomyoma cells and induces apoptosis."	( Ulipristal acetate for uterine fibroid-related symptoms. Koskas, M; Luton, D; Puchar, A, 2015)	2.58
"Ulipristal acetate (UPA) is a possible option for medical treatment of myomas."	( Myoma migration: an unexpected "effect" with Ulipristal acetate treatment. Dubuisson, J; Marci, R; Petignat, P; Willame, A, 2016)	1.42
"Ulipristal acetate is an approved preoperative treatment for uterine fibroids, and has demonstrated efficacy in reducing MBL."	( Heavy menstrual bleeding: An update on management. Davies, J; Kadir, RA, 2017)	1.18
"Ulipristal acetate is a progesterone agonist/antagonist emergency contraceptive approved for the prevention of pregnancy to be taken as soon as possible, within 120 hours after unprotected intercourse or a known or suspected contraceptive failure. "	( Ulipristal acetate for emergency contraception. Jarvis, CI; Melillo, SN; Snow, SE, 2011)	3.25
"Ulipristal acetate (UPA) is a newly developed emergency contraceptive currently available in the USA and Europe. "	( Ulipristal acetate: a new emergency contraceptive. Bulloch, MN; Sullivan, JL, 2011)	3.25
"Ulipristal acetate (UPA) is a selective progesterone receptor modulator approved for EC use in the United States in August 2010."	( Ulipristal acetate: review of the efficacy and safety of a newly approved agent for emergency contraception. Maltz, FN; Richardson, AR, 2012)	2.54
"Ulipristal acetate (UPA) is a progesterone receptor (PR) modulator considered for long-term administration in contraception and is currently being registered for the treatment of uterine fibroids."	( Ulipristal acetate does not impact human normal breast tissue. Chaouat, M; Communal, L; Courtin, A; Dumont, S; Forgez, P; Gompel, A; Hugon-Rodin, J; Lahlou, N; Mourra, N; Vilasco, M, 2012)	2.54
"Ulipristal acetate (UPA) is a new effective option to prevent unintended pregnancies up to 5 days after unprotected intercourse. "	( Results from pooled Phase III studies of ulipristal acetate for emergency contraception. Moreau, C; Trussell, J, 2012)	2.09
"Ulipristal acetate (UPA) is an selective progesterone receptor modulator (SPRM) which has been in use since 2010 as an effective alternative emergency contraception (EC) regimen to Levonorgestrel (LNG)."	( Ulipristal acetate and its role in emergency contraception: a comment. Peitsidis, P, 2012)	2.54
"Ulipristal acetate is a selective progesterone receptor modulator that was approved by the U.S."	( Ulipristal acetate: the newest emergency contraceptive. Wilton, JM, )	2.3
"Ulipristal acetate (UPA) is a novel form of emergency contraception (EC) that appears to be more effective than the prevailing method, single-dose levonorgestrel (LNG). "	( The price of emergency contraception in the United States: what is the cost-effectiveness of ulipristal acetate versus single-dose levonorgestrel? Bayer, LL; Caughey, AB; Edelman, AB; Rodriguez, MI, 2013)	2.05
"Ulipristal acetate is a novel selective progesterone receptor modulator for the treatment of benign gynecological conditions such as uterine myoma. "	( Changes in gastric pH and in pharmacokinetics of ulipristal acetate - a drug-drug interaction study using the proton pump inhibitor esomeprazole. Gotteland, JP; Lecomte, V; Osterloh, I; Pohl, O, 2013)	2.09

Effects

Ulipristal acetate (UPA) has been recognized as an alternative strategy to surgery in the management of symptomatic women with uterine fibroids. It has good oral bioavailability and a half-life allowing one single oral administration per day.

Excerpt	Reference	Relevance
"Ulipristal acetate has demonstrated efficacy for the preoperative treatment of leiomyomas, but not for all patients."	( Inefficiency of ulipristal acetate on uterus leiomyomas as an additional sign to suspect leiomyosarcoma. Borja De Mozota, D; Kadhel, P; Smail, M, 2017)	1.52
"Ulipristal acetate (UPA) has been recognized as an alternative strategy to surgery in the management of symptomatic women with uterine fibroids. "	( Unexpected uterine leiomyosarcoma in a woman with multiple myomas treated with ulipristal acetate: case report and literature review. Biglia, N; D'alonzo, M; Garbagnati, M; Menato, G; Modaffari, P; Pecchio, S, 2018)	2.15
"Ulipristal acetate (UPA) has been the first selective progesterone-receptor modulator approved for the preoperative and long-term treatment for uterine fibroids Ferrero et al."	( Disappearance of a myoma after pregnancy in a 38 years old patient, treated by ulipristal acetate without success before getting pregnant. Collinet, P; Cosson, M; Giraudet, G; Pécout, M; Rubod, C, 2019)	1.46
"Ulipristal acetate has good oral bioavailability and a half-life allowing one single oral administration per day for the management of fibroids."	( The clinical pharmacology and pharmacokinetics of ulipristal acetate for the treatment of uterine fibroids. Gotteland, JP; Pohl, O; Zobrist, RH, 2015)	1.39
"Ulipristal acetate has recently shown particular promise for providing long-term relief from uterine fibroids."	( Endocrinology of uterine fibroids: steroid hormones, stem cells, and genetic contribution. Bulun, SE; Moravek, MB, 2015)	1.14
"Ulipristal acetate has been shown to induce amenorrhea rapidly in women with uterine fibroids, and it can be a useful treatment in the emergency management of fibroid-related acute abnormal uterine bleeding."	( Use of Ulipristal Acetate for the Management of Fibroid-Related Acute Abnormal Uterine Bleeding. Arendas, K; Leyland, NA, 2016)	2.33
"Ulipristal acetate has been found to be non-inferior to other pre-operative treatments of uterine fibroids, particularly leuprolide. "	( Ulipristal acetate for pre-operative treatment of moderate-to-severe uterine fibroids in women of reproductive age in The Netherlands: cost minimization analysis and budget impact analysis. Postma, MJ; van Asselt, AD; Zakiyah, N, 2017)	3.34

Treatment

Ulipristal acetate treatment resulted in increased messenger ribonucleic acid (mRNA) levels of steroid receptors compared with pretreatment secretory endometrium. Treatment for 13 weeks effectively controlled excessive bleeding due to uterine fibroids.

Excerpt	Reference	Relevance
"Ulipristal acetate treatment resulted in increased messenger ribonucleic acid (mRNA) levels of steroid receptors compared with pretreatment secretory endometrium; decreased mRNA levels of 17- and 11-beta-hydroxysteroid dehydrogenases compared with pretreatment proliferative endometrium and pretreatment secretory endometrium; reduced cell proliferation compared with pretreatment proliferative endometrium; and altered mRNA levels of progesterone-regulated genes. "	( The endometrial response to modulation of ligand-progesterone receptor pathways is reversible. Chodankar, RR; Critchley, HOD; Murray, A; Nicol, M; Whitaker, LHR; Williams, ARW, 2021)	2.06
"When treated with ulipristal acetate, both patient leiomyoma tissue and leiomyoma cells grown in 3-dimensional cultures show a decrease in the expression of NFAT5 protein, solute transporters AKR1B1 and SLC5A3, and results in an associated decline in the expression of proteoglycans, versican, aggrecan, and brevican."	( Ulipristal Acetate Mediates Decreased Proteoglycan Expression Through Regulation of Nuclear Factor of Activated T-Cells (NFAT5). Britten, JL; Catherino, WH; Lewis, TD; Malik, M, 2019)	2.28
"Treatment with ulipristal acetate for 13 weeks effectively controlled excessive bleeding due to uterine fibroids and reduced the size of the fibroids. "	( Ulipristal acetate versus placebo for fibroid treatment before surgery. Bestel, E; Bouchard, P; Donnez, J; Ivanova, T; Jilla, MP; Loumaye, E; Mara, M; Osterloh, I; Puscasiu, L; Tatarchuk, TF; Terrill, P; Ugocsai, G; Zakharenko, NF, 2012)	2.17

Toxicity

Ulipristal acetate (UPA), a selective progesterone receptor modulator, is safe and effective for emergency contraception up to 5 days (120 h) following unprotected intercourse. Less than 5% of patients discontinuing treatment due to adverse events.

Excerpt	Reference	Relevance
"Ulipristal acetate (UPA), a selective progesterone receptor modulator, when taken as a single 30-mg dose, is safe and effective for emergency contraception up to 5 days (120 h) following unprotected intercourse."	( Ulipristal acetate: a new emergency contraceptive that is safe and more effective than levonorgestrel. Fine, PM, 2011)	3.25
" The most commonly (>10%) reported adverse events included headache, nausea, and abdominal pain."	( Ulipristal acetate: review of the efficacy and safety of a newly approved agent for emergency contraception. Maltz, FN; Richardson, AR, 2012)	1.82
" No adverse effects were found that would raise concerns about potential pre-malignancy."	( A 39-week oral toxicity study of ulipristal acetate in cynomolgus monkeys. Bergeron, C; Gotteland, JP; Pohl, O; Williams, AR, 2013)	0.67
" Safety assessments included vital signs, physical examination, ECG, clinical laboratory tests and reporting of adverse events."	( Ulipristal acetate - safety and pharmacokinetics following multiple doses of 10-50 mg per day. Gotteland, JP; Osterloh, I; Pohl, O, 2013)	1.83
" Mild or moderate adverse events occurred with similar frequency in UPA and placebo groups."	( Ulipristal acetate - safety and pharmacokinetics following multiple doses of 10-50 mg per day. Gotteland, JP; Osterloh, I; Pohl, O, 2013)	1.83
" Ulipristal acetate was well tolerated with less than 5% of patients discontinuing treatment due to adverse events."	( Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Arhendt, HJ; Barlow, DH; Bestel, E; Bouchard, P; Donnez, J; Donnez, O; Dumitrascu, MC; Fauser, BC; Fernandez, H; Hudecek, R; Kasilovskiene, Z; Loumaye, E; Matule, D; Osterloh, I; Terrill, P; Zatik, J, 2015)	1.6
" Short-term administration of UPA has been shown to be safe at short follow-up (months) and it is associated with minimal adverse side effects; further studies with longer follow-up are required to define the safety profile of UPA on endometrial histology."	( Drug safety evaluation of ulipristal acetate in the treatment of uterine fibroids. Bizzarri, N; Candiani, M; Ferrero, S; Leone Roberti Maggiore, U; Scala, C; Tafi, E; Venturini, PL, 2015)	0.72
" To determine whether LNG, UPA or COC (Yuzpe) ECPs are safe for women with certain characteristics or medical conditions, we searched the PubMed and Cochrane databases for articles published from date of inception until May 2015 pertaining to the safety of LNG, UPA or Yuzpe ECP use."	( Safety data for levonorgestrel, ulipristal acetate and Yuzpe regimens for emergency contraception. Curtis, KM; Jatlaoui, TC; Riley, H, 2016)	0.72
"Ulipristal acetate (UPA) 30 mg is safe and effective for emergency contraception (EC)."	( A prospective, open-label, multicenter study to assess the pharmacodynamics and safety of repeated use of 30 mg ulipristal acetate. Brache, V; Cochon, L; Jesam, C; Kapp, N; Levy-Gompel, D; Salvatierra, AM; Williams, A, 2016)	2.09
" In total, adverse events were reported in 10 (16%), 12 (19%), 8 (14%) and 5 (9%) subjects, during treatment courses 5, 6, 7 and 8, respectively of which the most frequent adverse events were headache and hot flush."	( Safety after extended repeated use of ulipristal acetate for uterine fibroids. Arriagada, P; Barlow, DH; Bouchard, P; Donnez, J; Fauser, BC; Lemieszczuk, B; Palacios, S; Skouby, SO; Tomaszewski, J; Vázquez, F; William, AR, 2017)	0.73
", ulipristal acetate pills, levonorgestrel pills, and the copper-IUD), carry only mild side effects and serious adverse events are essentially unknown."	( The safety of available and emerging options for emergency contraception. Lee, JK; Schwarz, EB, 2017)	1.18
" Main outcome measure The survey focused on the utilization of emergency contraceptives without a prescription in Germany, and on the pharmacists' experiences with (potential) problems and concerns regarding safe use."	( Trends in dispensing oral emergency contraceptives and safety issues: a survey of German community pharmacists. Freudewald, L; Ganso, M; Said, A; Schulz, M, 2019)	0.51
" Most adverse events were mild/moderate in severity and decreased in frequency with each course."	( Phase III long-term study to evaluate the efficacy and safety of ulipristal acetate in Japanese patients with uterine fibroids. Murakawa, H; Nakano, Y; Osuga, Y; Yamauchi, Y, 2021)	0.86
"0%) of patients were discontinuing Ulipristal acetate due to adverse effects."	( Efficacy and Safety of Repeated Use of Ulipristal Acetate in Uterine Fibroids. Arzoo, S; Ferdous, NE; Khatun, R; Mahmood, S; Rahman, R; Tanzin, F; Yousuf, S, 2023)	1.46

Pharmacokinetics

Is there a pharmacodynamic interaction between ulipristal acetate (UPA) 30 mg for emergency contraception and a daily progestin-only contraceptive pill, desogestrel (DSG) 0.2 mg?

Excerpt	Reference	Relevance
" Blood samples for pharmacokinetic analysis were collected on Days 1 and 10 at intervals until 168 h after multiple dosing."	( Ulipristal acetate - safety and pharmacokinetics following multiple doses of 10-50 mg per day. Gotteland, JP; Osterloh, I; Pohl, O, 2013)	1.83
" UPA median tmax was 0·75 and 0·89 h, and mean plasma half-life was between 38 and 49 h."	( Ulipristal acetate - safety and pharmacokinetics following multiple doses of 10-50 mg per day. Gotteland, JP; Osterloh, I; Pohl, O, 2013)	1.83
"Geometric mean Cmax and AUCs of UPA were increased by 24% [geometric mean ratio point estimate (90% CI): 1·24 (1·01-1·52)] and +224% and +227% [geometric mean ratio point estimates (90% CI): AUC0-t 3·24 (2·75-3·83) and AUC0-∞ (3·27 (2·79-3·83)], respectively, with no effect on median tmax or t1/2."	( Effects of erythromycin at steady-state concentrations on the pharmacokinetics of ulipristal acetate. Gotteland, JP; Osterloh, I; Pohl, O, 2013)	0.62
"Concomitant use of ulipristal acetate with erythromycin at therapeutic concentrations led to a limited increase in Cmax and a 3-fold increase in AUCs for UPA and to a decrease in Cmax and an increase in AUCs and prolonged elimination for PGL4002."	( Effects of erythromycin at steady-state concentrations on the pharmacokinetics of ulipristal acetate. Gotteland, JP; Osterloh, I; Pohl, O, 2013)	0.94
" In this context, the present article summarizes UPA's main clinical pharmacology and pharmacokinetic (PK) properties."	( The clinical pharmacology and pharmacokinetics of ulipristal acetate for the treatment of uterine fibroids. Gotteland, JP; Pohl, O; Zobrist, RH, 2015)	0.67
"This was a small, descriptive, pharmacodynamic study in which some findings differed by study site."	( A prospective, randomized, pharmacodynamic study of quick-starting a desogestrel progestin-only pill following ulipristal acetate for emergency contraception. Abitbol, JL; Brache, V; Cochon, L; Duijkers, IJ; Kapp, N; Klipping, C; Levy, DP; Monteil, C, 2015)	0.63
" This prospective open-label exploratory study was conducted to obtain additional data on the pharmacodynamic effects of repeated dose of UPA 30 mg during an 8-week period (effects on ovulation inhibition, hormonal levels, endometrium and cervical mucus)."	( A prospective, open-label, multicenter study to assess the pharmacodynamics and safety of repeated use of 30 mg ulipristal acetate. Brache, V; Cochon, L; Jesam, C; Kapp, N; Levy-Gompel, D; Salvatierra, AM; Williams, A, 2016)	0.65
" This work aimed to fully review pharmacokinetic aspects, namely focusing in the ulipristal acetate metabolism and other hypothetical toxicological underlying mechanisms that may predispose to drug-induced liver injury (DILI)."	( Pharmacokinetics, toxicological and clinical aspects of ulipristal acetate: insights into the mechanisms implicated in the hepatic toxicity. Dinis-Oliveira, RJ, 2021)	1.09
"To assess pharmacodynamic and pharmacokinetic outcomes of a novel copper (Cu) intrauterine system (IUS) releasing ulipristal acetate (UPA) in healthy women."	( Pharmacodynamics and pharmacokinetics of a copper intrauterine contraceptive system releasing ulipristal acetate: A randomized proof-of-concept study. Aprem, AS; Bagchi, IC; Blithe, DL; Brache, V; Cochon, L; Kannan, A; Kumar, N; Lansiaux, M; Loeven, D; Merkatz, R; Plagianos, M; Sitruk-Ware, R; Sussman, H; Tejada, AS; Vieira, CS; Williams, AR, 2021)	1.05

Compound-Compound Interactions

Excerpt	Reference	Relevance
" In 2016, the label of LNG was updated based on a drug-drug interaction (DDI) study showing a significant decrease in LNG exposure when co-administered with efavirenz, a known CYP3A4 inducer."	( Drug interactions between emergency contraceptive drugs and cytochrome inducers: literature review and quantitative prediction. Bourguignon, L; Capelle, A; France, M; Goutelle, S; Le Corvaisier, C; Tod, M, 2021)	0.62

Bioavailability

Ulipristal acetate has good oral bioavailability and a half-life allowing one single oral administration per day for the management of fibroids.

Excerpt	Reference	Relevance
"Concomitant use of ulipristal acetate with esomeprazole at therapeutic concentrations led to a modified absorption rate while exposure in terms of AUC remained close to bioequivalence limits."	( Changes in gastric pH and in pharmacokinetics of ulipristal acetate - a drug-drug interaction study using the proton pump inhibitor esomeprazole. Gotteland, JP; Lecomte, V; Osterloh, I; Pohl, O, 2013)	0.97
" Ulipristal acetate has good oral bioavailability and a half-life allowing one single oral administration per day for the management of fibroids."	( The clinical pharmacology and pharmacokinetics of ulipristal acetate for the treatment of uterine fibroids. Gotteland, JP; Pohl, O; Zobrist, RH, 2015)	1.58
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."	( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein. Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019)	0.51

Dosage Studied

All studies published as full papers in peer reviewed journals using GnRHa or ulipristal acetate as medical pre-treatment independent of route of administration or dosage before laparotomic or laparoscopic myomectomy.

Excerpt	Relevance	Reference
" Both Phase III clinical trials found that UPA does not lose efficacy within the 120-h dosing interval."	( Ulipristal acetate: a new emergency contraceptive. Bulloch, MN; Sullivan, JL, 2011)	1.81
" A contraceptive vaginal ring (CVR) also eliminates the need for daily dosing and therefore might improve the effectiveness of contraception."	( Vaginal ring delivery of selective progesterone receptor modulators for contraception. Jensen, JT, 2013)	0.39
"UPA, at the dosage used for EC, does not affect human embryo implantation process, in vitro."	( Effects of ulipristal acetate on human embryo attachment and endometrial cell gene expression in an in vitro co-culture system. Berger, C; Boggavarapu, NR; Gemzell-Danielsson, K; Lalitkumar, PG; Menezes, J, 2015)	0.81
"This study provides new insights on the mechanism of action of UPA on human embryo implantation, demonstrating that UPA in a dosage used for EC does not affect embryo viability and the implantation process of embryo."	( Effects of ulipristal acetate on human embryo attachment and endometrial cell gene expression in an in vitro co-culture system. Berger, C; Boggavarapu, NR; Gemzell-Danielsson, K; Lalitkumar, PG; Menezes, J, 2015)	0.81
" All studies published as full papers in peer reviewed journals using ulipristal acetate reporting on endometrial changes were included, independent of clinical indication, dosage taken and duration of therapy."	( Endometrial changes during ulipristal acetate use: A systematic review. De Milliano, I; Hehenkamp, WJK; Huirne, JAF; Ket, JCF; Van Hattum, D, 2017)	0.99
" There was no relationship between dosage and type and extent of lesions."	( Endometrial Changes in Surgical Specimens of Perimenopausal Patients Treated With Ulipristal Acetate for Uterine Leiomyomas. Bergeron, C; Chamorro-Santos, C; Crespo-Lora, V; Cruz-Viruel, N; Nogales, FF, 2018)	0.71
" All studies published as full papers in peer reviewed journals using GnRHa or ulipristal acetate as medical pre-treatment independent of route of administration or dosage before laparotomic or laparoscopic myomectomy were included."	( Pre-treatment with GnRHa or ulipristal acetate prior to laparoscopic and laparotomic myomectomy: A systematic review and meta-analysis. de Milliano, I; Hehenkamp, WJ; Huirne, JA; Ket, JC; Twisk, M, 2017)	0.98
" No dosage of UPA was 100% effective."	( Model for Hormonal Emergency Contraception (HEC) in cycling and mated guinea pigs - Studies with the Progesterone Receptor Modulators (PRM) Ulipristal Acetate (UPA/CDB2914) and EC317. Dehnhard, M; Elger, W; Friedrich, M; Jewgenow, K; Killeen, Z; Nickisch, K; Santhamma, B; Schneider, B; Wedemeyer, R, 2018)	0.68
" We also included data from 2 subjects who experienced rupture prior to COC dosing in the analysis."	( Combined oral contraceptive interference with the ability of ulipristal acetate to delay ovulation: A prospective cohort study. Edelman, AB; Hennebold, JD; Jensen, JT; McCrimmon, S; Messerle-Forbes, M; O'Donnell, A, 2018)	0.72
" Moderate to severe DDI were predicted in 17 cases with CYP3A4 inducers, and dosage adjustments were suggested."	( Drug interactions between emergency contraceptive drugs and cytochrome inducers: literature review and quantitative prediction. Bourguignon, L; Capelle, A; France, M; Goutelle, S; Le Corvaisier, C; Tod, M, 2021)	0.62

[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Role	Description
contraceptive drug	A chemical substance that prevents or reduces the probability of conception.
progestin	A synthetic progestogen.
progesterone receptor modulator	A hormone receptor modulator that acts as a complete or partial agonist or as an antagonist at the progesterone receptor.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Class	Description
3-oxo-Delta(4) steroid	A 3-oxo steroid conjugated to a C=C double bond at the alpha,beta position.
steroid ester
acetate ester	Any carboxylic ester where the carboxylic acid component is acetic acid.
20-oxo steroid	An oxo steroid carrying an oxo group at position 20.
tertiary amino compound	A compound formally derived from ammonia by replacing three hydrogen atoms by organyl groups.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Progesterone receptor	Homo sapiens (human)	IC50 (µMol)	0.0002	0.0000	0.5807	10.0000	AID323989
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Progesterone receptor	Homo sapiens (human)	EC50 (µMol)	0.1000	0.0001	0.4047	8.2000	AID323987
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Process	via Protein(s)	Taxonomy
ovulation from ovarian follicle	Progesterone receptor	Homo sapiens (human)
glandular epithelial cell maturation	Progesterone receptor	Homo sapiens (human)
regulation of DNA-templated transcription	Progesterone receptor	Homo sapiens (human)
signal transduction	Progesterone receptor	Homo sapiens (human)
G protein-coupled receptor signaling pathway	Progesterone receptor	Homo sapiens (human)
cell-cell signaling	Progesterone receptor	Homo sapiens (human)
positive regulation of gene expression	Progesterone receptor	Homo sapiens (human)
negative regulation of gene expression	Progesterone receptor	Homo sapiens (human)
paracrine signaling	Progesterone receptor	Homo sapiens (human)
negative regulation of phosphorylation	Progesterone receptor	Homo sapiens (human)
positive regulation of transcription by RNA polymerase II	Progesterone receptor	Homo sapiens (human)
lung alveolus development	Progesterone receptor	Homo sapiens (human)
regulation of epithelial cell proliferation	Progesterone receptor	Homo sapiens (human)
progesterone receptor signaling pathway	Progesterone receptor	Homo sapiens (human)
maintenance of protein location in nucleus	Progesterone receptor	Homo sapiens (human)
tertiary branching involved in mammary gland duct morphogenesis	Progesterone receptor	Homo sapiens (human)
regulation of transcription by RNA polymerase II	Progesterone receptor	Homo sapiens (human)
intracellular steroid hormone receptor signaling pathway	Progesterone receptor	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
RNA polymerase II cis-regulatory region sequence-specific DNA binding	Progesterone receptor	Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specific	Progesterone receptor	Homo sapiens (human)
transcription coactivator binding	Progesterone receptor	Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specific	Progesterone receptor	Homo sapiens (human)
DNA binding	Progesterone receptor	Homo sapiens (human)
nuclear steroid receptor activity	Progesterone receptor	Homo sapiens (human)
G protein-coupled receptor activity	Progesterone receptor	Homo sapiens (human)
steroid binding	Progesterone receptor	Homo sapiens (human)
protein binding	Progesterone receptor	Homo sapiens (human)
zinc ion binding	Progesterone receptor	Homo sapiens (human)
enzyme binding	Progesterone receptor	Homo sapiens (human)
identical protein binding	Progesterone receptor	Homo sapiens (human)
ATPase binding	Progesterone receptor	Homo sapiens (human)
estrogen response element binding	Progesterone receptor	Homo sapiens (human)
nuclear receptor activity	Progesterone receptor	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
plasma membrane	Progesterone receptor	Homo sapiens (human)
nucleoplasm	Progesterone receptor	Homo sapiens (human)
mitochondrial outer membrane	Progesterone receptor	Homo sapiens (human)
cytosol	Progesterone receptor	Homo sapiens (human)
chromatin	Progesterone receptor	Homo sapiens (human)
nucleus	Progesterone receptor	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Assay ID	Title	Year	Journal	Article
AID1346851	Human Progesterone receptor (3C. 3-Ketosteroid receptors)	2008	Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6	11-(pyridinylphenyl)steroids--a new class of mixed-profile progesterone agonists/antagonists.
AID1346986	P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen	2019	Molecular pharmacology, 11, Volume: 96, Issue:5	A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1296008	Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening	2020	SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1	Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346987	P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen	2019	Molecular pharmacology, 11, Volume: 96, Issue:5	A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347160	Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors	2020	Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49	Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347159	Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay	2020	Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49	Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID323987	Agonist activity at human PRB expressed in CHO cells	2008	Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6	11-(pyridinylphenyl)steroids--a new class of mixed-profile progesterone agonists/antagonists.
AID323989	Antagonist activity at human PRB expressed in CHO cells assessed as inhibition of Org 2058 induced-transactivation	2008	Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6	11-(pyridinylphenyl)steroids--a new class of mixed-profile progesterone agonists/antagonists.
AID323990	Antagonist activity at human PRB expressed in CHO cells assessed as inhibition of Org 2058 induced-transactivation relative to Org 31710	2008	Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6	11-(pyridinylphenyl)steroids--a new class of mixed-profile progesterone agonists/antagonists.
AID977608	Experimentally measured binding affinity data (IC50) for protein-ligand complexes derived from PDB	2014	The Journal of steroid biochemistry and molecular biology, Oct, Volume: 144 Pt B	Molecular determinants of the recognition of ulipristal acetate by oxo-steroid receptors.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	1 (0.28)	18.2507
2000's	2 (0.57)	29.6817
2010's	275 (77.90)	24.3611
2020's	75 (21.25)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	41 (10.90%)	5.53%
Reviews	102 (27.13%)	6.00%
Case Studies	34 (9.04%)	4.05%
Observational	22 (5.85%)	0.25%
Other	177 (47.07%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (64)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Pilot Prevention Study of the Effects of the Anti-progestin Ulipristal Acetate (UA) on Surrogate Markers of Breast Cancer Risk [NCT02408770]	Phase 2	24 participants (Actual)	Interventional	2016-01-22	Completed
A Prospective, Randomized, Double-blind, Cross-Over Study to Compare the Capacity to Prevent Follicular Rupture of CDB-2914 With Placebo, When Administered After the Ovulatory Process Has Been Triggered by the LH Surge [NCT01107093]	Phase 2	35 participants (Actual)	Interventional	2008-05-31	Completed
A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and [NCT01156857]	Phase 3	209 participants (Actual)	Interventional	2010-07-31	Completed
A Multi-center, Open-label, Non-comparative Study of the Safety and Contraceptive Efficacy of Continuous Daily Oral 10 mg of Ulipristal Acetate (UPA) [NCT03296098]	Phase 2	300 participants (Anticipated)	Interventional	2020-12-31	Suspended(stopped due to Awaiting FDA approval to continue)
A Randomized Study to Evaluate the Effect of a Contraceptive Vaginal Ring Delivering a Daily Dose of 2500 μg of Ulipristal Acetate Combined With a Single or Repeated Levonorgestrel 1.5mg Oral Dose on Inhibition of Ovulation, Endometrial Changes and Bleedi [NCT02451826]	Phase 1/Phase 2	19 participants (Actual)	Interventional	2015-05-31	Active, not recruiting
Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena, a Randomized Clinical Trial [NCT03186586]	Phase 4	32 participants (Anticipated)	Interventional	2017-07-01	Recruiting
[NCT02440750]	Phase 4	50 participants (Anticipated)	Interventional	2016-06-30	Not yet recruiting
Pharmacokinetics of Levonorgestrel and Ulipristal Acetate Emergency Contraception in Women With Normal and Obese Body Mass Index [NCT02689804]	Phase 4	34 participants (Actual)	Interventional	2015-07-10	Completed
The Effect of UPA on Women Ovarian Reserve [NCT02361892]	Phase 4	73 participants (Anticipated)	Interventional	2015-02-28	Recruiting
Cervical Preparation Using Ulipristal Acetate for Second Trimester Surgical Abortion [NCT03802149]	Early Phase 1	13 participants (Actual)	Interventional	2019-04-16	Completed
Intervention to End Recurrent Unscheduled Bleeding Trial: A Randomized-controlled Trial of Ulipristal Acetate for Unscheduled Bleeding in Etonogestrel Implant Users [NCT03118297]	Phase 3	65 participants (Actual)	Interventional	2017-05-01	Completed
A Prospective, Randomized, Double-blind Parallel-arm, Placebo-controlled Study to Assess the Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® (Ulipristal Acetate 30 mg) or Placebo. [NCT01569113]	Phase 4	76 participants (Actual)	Interventional	2012-03-31	Completed
Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis [NCT03325868]	Phase 4	0 participants (Actual)	Interventional	2018-02-28	Withdrawn(stopped due to IND issues)
Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion in Women With Previous Caesarian Section: A Randomized Controlled Trial. [NCT04989400]	Phase 4	24 participants (Actual)	Interventional	2019-01-01	Completed
A Multi-center, Randomized Study of the Efficacy of Ulipristal Acetate (UPA) 30 mg, Levonorgestrel (LNG) 1.5 mg, and LNG 3.0 mg for Emergency Contraception (EC) in Women With Weight ≥ 80 kg [NCT03537768]	Phase 4	1,200 participants (Anticipated)	Interventional	2018-07-12	Recruiting
Ulipristal Versus Gonadotropin-releasing Hormone Agonists Prior to Laparoscopic Myomectomy: a Double Blind Randomized Controlled Trial [NCT02288130]	Phase 4	100 participants (Anticipated)	Interventional	2014-12-31	Recruiting
A Retrospective, National, Multicenter Study Evaluating the Impact of Ulipristal Acetate (Esmya®) on Infertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques (ART) [NCT03349190]		127 participants (Actual)	Observational	2017-12-29	Completed
Prospective Observational Single Arm Open-Label Multicenter Study to Assess the Safety, Tolerability and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Adult Women [NCT01107106]		579 participants (Actual)	Observational	2010-05-31	Completed
A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of Three Successive Periods of 3-month Open-label PGL4001 Treatment, Each Followed by Ten Days of Double-blind Treatment With Progestin or Placebo and a Drug-free Period Until [NCT01252069]	Phase 3	132 participants (Actual)	Interventional	2011-01-31	Completed
IVF Outcome Following Treatment With Ulipristal Acetate for Myomatous Uterus After at Least One IVF Failure [NCT02601196]	Phase 4	20 participants (Anticipated)	Interventional	2016-09-30	Not yet recruiting
On Demand Contraception: Investigating Efficacy of Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility [NCT03354117]	Phase 1	12 participants (Actual)	Interventional	2018-03-15	Completed
Advance Provision of Postpartum Emergency Contraception and Its Effects on Reproductive Autonomy [NCT05285605]		75 participants (Anticipated)	Observational	2022-03-01	Recruiting
A Pilot Prospective, Randomized Pharmacodynamic Study With Assessment of Ulipristal Acetate on Ovarian Activity Following Quickstart of the Etonogestrel Contraceptive Implant [NCT04291001]	Early Phase 1	40 participants (Actual)	Interventional	2020-09-04	Active, not recruiting
Ulipristal Acetate Therapy Versus Uterine Artery Embolization in Management of Uterine Fibroids [NCT04832906]	Phase 4	70 participants (Actual)	Interventional	2019-03-13	Completed
A Phase 2, Randomized Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914 on Inhibition of Ovulation, Endometrial Changes and Bleeding Patterns in Normal Cycling Women [NCT00791297]	Phase 2	55 participants (Actual)	Interventional	2008-10-31	Completed
Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma [NCT02361879]	Phase 4	146 participants (Anticipated)	Interventional	2015-02-28	Recruiting
A Single-Dose, Open-Label, Pharmacokinetic Study Of Ulipristal Acetate In Healthy Subjects With Normal Renal Function And Patients With Moderately Or Severly Impaired Renal Function [NCT02634437]	Phase 1	19 participants (Actual)	Interventional	2015-12-01	Completed
The Effectiveness and Safety of Ulipristal Acetate in Women With Symptomatic Uterine Fibroid [NCT04132349]	Phase 4	25 participants (Actual)	Interventional	2019-10-23	Terminated(stopped due to Ulipristal Acetate was recalled)
Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Shrink Leiomyomata [NCT00290251]	Phase 2	72 participants (Actual)	Interventional	2006-02-28	Completed
Liver Safety Assessment During Ulipristal Acetate Treatment for Uterine Fibroids [NCT04004884]		60 participants (Anticipated)	Observational	2019-05-23	Recruiting
A Prospective, Randomized, Single-blind Study to Compare the Effects of Daily Ulipristal Acetate (UPA) 10mg With a Combined Oral Contraceptive (COC) Pill on Breast Epithelial Cell Proliferation in Reproductive Age Women [NCT02922127]	Phase 1	29 participants (Actual)	Interventional	2016-12-16	Completed
A Phase IIb Randomized, Double Blind, Comparative Study to Assess the Efficacy, Safety, Tolerability and Inhibition of Ovulation 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 [NCT01953679]	Phase 2	180 participants (Actual)	Interventional	2014-03-31	Completed
Phase IV Pilot Study of Ulipristal Acetate for Treatment of Endometriosis-related Pelvic Pain [NCT02213081]	Phase 4	25 participants (Anticipated)	Interventional	2015-02-28	Active, not recruiting
A Phase III, Multicentre, Extension Study Investigating the Efficacy and Safety of Repeated Intermittent 3-month Courses of Open-label Administration of Ulipristal Acetate, in Subjects With Symptomatic Uterine Myomas and Heavy Uterine Bleeding [NCT01642472]	Phase 3	64 participants (Actual)	Interventional	2012-07-31	Completed
Pilot Study on the Pre-operative Use of Ulipristal on Fibroid in Chinese Population [NCT02825719]	Phase 4	31 participants (Actual)	Interventional	2015-12-02	Terminated(stopped due to Ulipristal was withdrawal from the market)
Effect of Ulipristal Acetate Administration on Serum Progesterone Levels and Glycodelin-A Endometrial Pattern in Women Undergoing Controlled Ovulation Stimulation. [NCT01391845]		16 participants (Anticipated)	Interventional	2011-07-31	Not yet recruiting
Disparities in Emergency Contraceptive Metabolism Dictate Efficacy [NCT05674513]	Phase 4	140 participants (Anticipated)	Interventional	2023-01-09	Recruiting
Efficacy of Ulipristalacetate in Comparison to Surgery Before IVF/ICSI-treatment in Women With Intramural Fibroids: Effect on Reproductive Outcome. [NCT04028986]		40 participants (Anticipated)	Observational	2016-01-01	Active, not recruiting
Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Reduce Bleeding in Premenopausal Women With Abnormal Uterine Bleeding: A Pilot Study [NCT01493791]	Early Phase 1	0 participants (Actual)	Interventional	2011-11-08	Withdrawn
Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - PK and PD of 30mg and 60mg UPA [NCT02859337]	Phase 4	57 participants (Actual)	Interventional	2017-05-30	Completed
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CDB-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Sex [NCT00411684]	Phase 3	1,623 participants (Actual)	Interventional	2006-11-30	Completed
Levonorgestrel Intrauterine System For Emergency Contraception: a Randomized Control Trial [NCT01539720]		273 participants (Actual)	Interventional	2012-12-31	Completed
A Randomized, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate in Women With Anemia Associated With Uterine Leiomyomas [NCT01553123]	Phase 3	0 participants (Actual)	Interventional	2012-04-30	Withdrawn
Pharmacokinetic Comparison of Two Preparations of the Selective Progesterone Receptor Modular CDB2914 [NCT00041899]	Phase 1	15 participants	Interventional	2002-05-31	Completed
Biologic Activity of a Selective Progesterone Receptor Modulator, CDB-2914, in Post-Menopausal Women [NCT00009659]	Phase 2	58 participants	Interventional	2001-01-31	Completed
Treatment of Leiomyomata With the Selective Progesterone Receptor Modulator CDB-2914 [NCT00044876]	Phase 2	56 participants (Actual)	Interventional	2002-09-02	Completed
A Phase III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas [NCT00755755]	Phase 3	241 participants (Actual)	Interventional	2008-10-31	Completed
A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas [NCT00740831]	Phase 3	301 participants (Actual)	Interventional	2008-08-31	Completed
Uterine Fibroids: Impact of Ulipristal Acetate 10 mg on ART Results [NCT02425878]	Phase 3	2 participants (Actual)	Interventional	2015-10-19	Terminated(stopped due to Lack of availibility of eligible subjects)
Observational Study on the Clinical Efficacy of Ulipristal for Emergency Contraception When Administered Before or After Ovulation [NCT02517463]		700 participants (Actual)	Observational	2011-05-31	Completed
Ulipristal Acetate for Use in Early Pregnancy Loss: A Phase 2 Pilot Feasibility Study [NCT05216952]	Phase 2	3 participants (Actual)	Interventional	2022-05-11	Completed
Determining the Impact of Combined Hormonal Contraceptives on Ulipristal Acetate [NCT02577601]	Phase 4	36 participants (Actual)	Interventional	2015-09-08	Completed
Quality of Life Outcomes for Ulipristal Acetate and Tranexamic Acid in the Management of Heavy Menstrual Bleeding: A Pilot Randomized Control Trial [NCT03027973]	Phase 1	0 participants (Actual)	Interventional	2020-01-31	Withdrawn(stopped due to PI made the decision to not continue the study. It was at the Health Canada review stage.)
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) on Ovulation, Endometrial Changes and Bleeding Patterns in No [NCT03230539]	Phase 1	30 participants (Anticipated)	Interventional	2017-05-01	Recruiting
A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Intermittent Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas [NCT02147158]	Phase 3	432 participants (Actual)	Interventional	2014-01-29	Completed
Advantages of Ulipristal Acetate for the Preoperative Treatment of Hypoechoic Cellular Leiomyomas [NCT02361905]	Phase 4	42 participants (Anticipated)	Interventional	2015-02-28	Recruiting
Ulipristal Acetate Versus GnRH Analogue for Myometrial Preservation in Patients With Submucosal Uterine Leiomyoma G2 [NCT02357563]	Phase 4	110 participants (Anticipated)	Interventional	2015-02-28	Recruiting
A Multi-Center, Open-Label Trial Investigating Behavior Related to Ella® Use in a Simulated OTC Environment (LIBRella) [NCT03208985]	Phase 3	1,270 participants (Actual)	Interventional	2017-05-23	Completed
Alternative Provision of Medication Abortion Via Advance Provision [NCT03829696]	Phase 4	0 participants (Actual)	Interventional	2020-01-31	Withdrawn(stopped due to The study is not proceeding at this time.)
Pilot Phase II, Randomized , and Control in Double Blind Placebo Effectiveness a 3 Months on Bleeding Fibroids Treatment With ULIPRISTAL ACETATE 10 mg/Day in Patients Suffering From Symptomatic Endometriosis [NCT02587000]	Phase 2	26 participants (Actual)	Interventional	2015-06-16	Completed
A Randomized, Parallel-group, Double-blind Placebo-controlled and Open Label Active Controlled, Multi-center Study to Assess the Efficacy and Safety of Vilaprisan in Patients With Uterine Fibroids [NCT02465814]	Phase 2	120 participants (Actual)	Interventional	2015-06-30	Completed
A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids [NCT01629563]	Phase 3	451 participants (Actual)	Interventional	2012-06-30	Completed
An Open-label, Parallel Group, Multi-center Study to Investigate Pharmacodynamic Effects After Daily Administration of Vilaprisan or Ulipristal Acetate for 8-12 Weeks in Patients With Uterine Fibroids for Whom Surgery (Hysterectomy or Myomectomy) is Plann [NCT03342859]	Phase 1	10 participants (Actual)	Interventional	2017-11-16	Terminated(stopped due to Due to findings in the preclinical carcinogenicity studies for vilaprisan (BAY1002670))
A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas [NCT02147197]	Phase 3	157 participants (Actual)	Interventional	2014-03-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00290251 (2) [back to overview]	Shrinkage of Fibroids - Size of Fibroids
NCT00290251 (2) [back to overview]	Short Form-36 and Uterine Fibroid Symptom Quality of Life
NCT00411684 (4) [back to overview]	Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)
NCT00411684 (4) [back to overview]	Frequencies of Subjects With Treatment Emergent Adverse Events
NCT00411684 (4) [back to overview]	Impact on Menstrual Bleeding Patterns
NCT00411684 (4) [back to overview]	Pregnancy Rate
NCT00740831 (4) [back to overview]	Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13
NCT00740831 (4) [back to overview]	Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist
NCT00740831 (4) [back to overview]	Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist
NCT00740831 (4) [back to overview]	Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)
NCT00755755 (2) [back to overview]	Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)
NCT00755755 (2) [back to overview]	Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)
NCT01629563 (7) [back to overview]	Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids
NCT01629563 (7) [back to overview]	Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)
NCT01629563 (7) [back to overview]	Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)
NCT01629563 (7) [back to overview]	Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)
NCT01629563 (7) [back to overview]	Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses
NCT01629563 (7) [back to overview]	Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4
NCT01629563 (7) [back to overview]	Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses
NCT02147158 (6) [back to overview]	Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1
NCT02147158 (6) [back to overview]	Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1
NCT02147158 (6) [back to overview]	Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2
NCT02147158 (6) [back to overview]	Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1
NCT02147158 (6) [back to overview]	Time to Absence of Bleeding on Treatment During Treatment Course 1
NCT02147158 (6) [back to overview]	Time to Absence of Bleeding on Treatment During Treatment Course 2
NCT02147197 (4) [back to overview]	Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment
NCT02147197 (4) [back to overview]	Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment
NCT02147197 (4) [back to overview]	Time to Absence of Bleeding on Treatment
NCT02147197 (4) [back to overview]	Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Period
NCT02517463 (3) [back to overview]	Change in the Length of the Index Menstrual Cycle From Baseline
NCT02517463 (3) [back to overview]	Failure Rate
NCT02517463 (3) [back to overview]	Percentage of Pregnancies Prevented (PPP)
NCT02577601 (1) [back to overview]	Number of Participants With Follicle Rupture
NCT02689804 (10) [back to overview]	Elimination Half-life of Serum LNG
NCT02689804 (10) [back to overview]	Elimination Half-life of Serum UPA
NCT02689804 (10) [back to overview]	Maximum Concentration of Serum LNG
NCT02689804 (10) [back to overview]	Time to Maximum Concentration of Serum LNG
NCT02689804 (10) [back to overview]	Time to Maximum Concentration of Serum UPA
NCT02689804 (10) [back to overview]	Maximum Concentration of Serum UPA
NCT02689804 (10) [back to overview]	Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration
NCT02689804 (10) [back to overview]	Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration
NCT02689804 (10) [back to overview]	Clearance of Serum LNG
NCT02689804 (10) [back to overview]	Clearance of Serum UPA
NCT03118297 (4) [back to overview]	Ovulation Status Measured by Weekly Serum Progesterone Levels
NCT03118297 (4) [back to overview]	Number of Participants With Medication Side Effects by 30 Days
NCT03118297 (4) [back to overview]	Number of Participants With Bleeding Cessation by Day 10
NCT03118297 (4) [back to overview]	Number of Bleeding/Spotting Days With Use of Ulipristal Acetate as Measured by Daily Bleeding Diaries
NCT03208985 (3) [back to overview]	Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.
NCT03208985 (3) [back to overview]	Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.
NCT03208985 (3) [back to overview]	Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.
NCT05216952 (9) [back to overview]	Number of Participants With Resolution of Early Pregnancy Loss Following Study Intervention
NCT05216952 (9) [back to overview]	Percentage of Participants Adherent to Study Protocol
NCT05216952 (9) [back to overview]	Percentage of Participants Recruited to Study Protocol
NCT05216952 (9) [back to overview]	Percentage of Participants Retained in Study Protocol
NCT05216952 (9) [back to overview]	Median Acceptability of Study Intervention
NCT05216952 (9) [back to overview]	Number of Participants Needing Additional Medication for Resolution of Early Pregnancy Loss
NCT05216952 (9) [back to overview]	Number of Participants With Treatment-Related Adverse Events
NCT05216952 (9) [back to overview]	Number of Participants With Treatment-Related Side Effects
NCT05216952 (9) [back to overview]	Number of Participants Needing Surgical Management for Resolution of Early Pregnancy Loss

Shrinkage of Fibroids - Size of Fibroids

The primary outcome, fibroid volume, was calculated by an ellipsoid formula (π/6xd1xd2xd3) using orthogonal three-dimensional measurements taken from pelvic MRI scan. Individual volumes were summed to assess total fibroid volume for each woman, which were log-transformed before analysis. Women with paired MRI results were included in this intent to treat analysis, even if they did not take all study medication. Fibroids were included if they were seen on both studies.The absolute change in cm3 between baseline and end of treatment was calculated and its log was used for statistics and reporting the results in the data table below. (NCT00290251)
Timeframe: 3 months (baseline to end of treatment)

Intervention	logcm3 (Mean)
Ulipristal Acetate -20mg	-0.27
Ulipristal Acetate - 10 mg	-0.18
Placebo	0.07

Intervention	units on a scale (Mean)
	SF-36 Physical Component	SF-36 Mental Component	UFS Symptom Severity Score	UFS Overall health related quality of life	UFS Concern subscore	UFS Energy/mood subscore	UFS Control subscore	UFS self-conscious subscore	UFS sexual function subscore	UFS activities subscore	UFS composite bleeding subscore
Placebo	-1.5	-2.2	-4.2	8.6	12.1	3.7	9.1	15.8	18.7	56.1	0.4
Ulipristal Acetate -10 and 20mg	4.2	4.1	-28.3	27.8	46.1	19.2	20.3	19.0	25.7	83.9	2.1

Intervention	percentage of participants (Number)
	Headache	Nausea	Abdominal pain	Dysmenorrhea	Dizziness	Fatigue
CDB-2914	9.3	9.2	6.8	4.1	3.5	3.4

Intervention	Log 10 (Log cm3) Total volume (Mean)
A (PGL4001 5mg)	-0.179
B (PGL4001 10mg)	-0.220
C (GnRH-agonist)	-0.268

Intervention	log 10 (log pg/ml) E2 (Mean)
A (PGL4001 5mg)	1.897
B (PGL4001 10mg)	1.843
C (GnRH-agonist)	1.381

Intervention	percentage of change from baseline (Median)
Ulipristal Acetate (PGL4001) 5mg	-67.0
Ulipristal Acetate (PGL4001) 10mg	-70.4

Intervention	percentage of change from baseline (Median)
Ulipristal Acetate (PGL4001) 5mg	-20.0
Ulipristal Acetate (PGL4001) 10mg	-23.0

Intervention	percentage of change from baseline (Median)
Ulipristal Acetate (PGL4001) 5mg	20.69
Ulipristal Acetate (PGL4001) 10mg	15.52

Intervention	percentage of change from baseline (Median)
Ulipristal Acetate (PGL4001) 5mg	-31.25
Ulipristal Acetate (PGL4001) 10mg	-28.13

Intervention	percentage of subjects (Number)
Ulipristal Acetate (PGL4001) 5mg	48.7
Ulipristal Acetate (PGL4001) 10mg	60.5

Intervention	percentage of participants (Number)
Ulipristal Acetate (PGL4001) 5mg	69.6
Ulipristal Acetate (PGL4001) 10mg	74.5

Intervention	percentage of participants (Number)
Ulipristal Acetate (PGL4001) 5mg	67.1
Ulipristal Acetate (PGL4001) 10mg	71.9

Intervention	score on a scale (Mean)
	Baseline	Change from Baseline at Week 12
Placebo	28.70	14.25
UPA 10 mg	33.24	54.73
UPA 5 mg	27.52	50.19

Intervention	ng/mL (Number)
	Lower endpoint	Upper endpoint
Placebo	0.0	1.3
Ulipristal Acetate	0.0	4.4

Intervention	participants (Number)
	Headache	Nausea/Vomiting	Feeling flushed	Abdominal pain	Dizziness	Other	Did not experience
Placebo	6	3	1	2	1	1	23
Ulipristal Acetate	3	1	0	2	1	1	26

Intervention	score on a scale (Median)
	Would you use these medications again if you had another miscarriage?	Would you recommend these medications to a friend with a miscarriage?	If possible to take Ulipristal Acetate (UPA) at home, would you be more or less likely to use again?	If possible to take UPA at a different time, would you be more or less likely to use again?
Ulipristal Acetate (UPA) 90 mg	3	4	4	3

Intervention	Participants (Count of Participants)
	Bleeding requiring hospitalization and/or blood transfusion	Pelvic infection requiring hospitalization and/or antibiotics	Other
Ulipristal Acetate (UPA) 90 mg	1	0	0

Condition	Indicated	Relationship Strength	Studies	Trials
Congenital Zika Syndrome [description not available]	0	2.25	1	0
Disease Models, Animal Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.	0	2.69	2	0
Zika Virus Infection A viral disease transmitted by the bite of AEDES mosquitoes infected with ZIKA VIRUS. Its mild DENGUE-like symptoms include fever, rash, headaches and ARTHRALGIA. The viral infection during pregnancy, in rare cases, is associated with congenital brain and ocular abnormalities, called Congenital Zika Syndrome, including MICROCEPHALY and may also lead to GUILLAIN-BARRE SYNDROME.	0	2.25	1	0
Breast Cancer [description not available]	0	11.63	6	1
Fibroid [description not available]	0	20.37	209	46
Breast Neoplasms Tumors or cancer of the human BREAST.	1	8.63	6	1
Leiomyoma A benign tumor derived from smooth muscle tissue, also known as a fibroid tumor. They rarely occur outside of the UTERUS and the GASTROINTESTINAL TRACT but can occur in the SKIN and SUBCUTANEOUS TISSUE, probably arising from the smooth muscle of small blood vessels in these tissues.	1	25.13	418	92
Acute Liver Injury, Drug-Induced [description not available]	0	5.64	14	0
Acute Hepatic Failure [description not available]	0	4.11	4	0
Infections, Roseolovirus [description not available]	0	2.31	1	0
Cytomegalovirus A genus of the family HERPESVIRIDAE, subfamily BETAHERPESVIRINAE, infecting the salivary glands, liver, spleen, lungs, eyes, and other organs, in which they produce characteristically enlarged cells with intranuclear inclusions. Infection with Cytomegalovirus is also seen as an opportunistic infection in AIDS.	0	2.31	1	0
Liver Failure, Acute A form of rapid-onset LIVER FAILURE, also known as fulminant hepatic failure, caused by severe liver injury or massive loss of HEPATOCYTES. It is characterized by sudden development of liver dysfunction and JAUNDICE. Acute liver failure may progress to exhibit cerebral dysfunction even HEPATIC COMA depending on the etiology that includes hepatic ISCHEMIA, drug toxicity, malignant infiltration, and viral hepatitis such as post-transfusion HEPATITIS B and HEPATITIS C.	0	4.11	4	0
Chemical and Drug Induced Liver Injury A spectrum of clinical liver diseases ranging from mild biochemical abnormalities to ACUTE LIVER FAILURE, caused by drugs, drug metabolites, herbal and dietary supplements and chemicals from the environment.	0	5.64	14	0
Cancer of the Uterus [description not available]	0	19.92	171	43
Uterine Neoplasms Tumors or cancer of the UTERUS.	0	19.92	171	43
Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.	0	16.31	80	10
Heavy Menstrual Bleeding [description not available]	0	16.11	48	24
Menorrhagia Excessive uterine bleeding during MENSTRUATION.	0	16.11	48	24
Sarcoma, Epithelioid [description not available]	0	2.6	1	0
Sarcoma A connective tissue neoplasm formed by proliferation of mesodermal cells; it is usually highly malignant.	0	7.6	1	0
Blood Loss, Surgical Loss of blood during a surgical procedure.	0	3.97	2	1
Anemia A reduction in the number of circulating ERYTHROCYTES or in the quantity of HEMOGLOBIN.	0	9.97	12	9
Angiogenesis, Pathologic [description not available]	0	2.25	1	0
Hemorrhage, Uterine [description not available]	0	12.83	26	8
Uterine Hemorrhage Bleeding from blood vessels in the UTERUS, sometimes manifested as vaginal bleeding.	0	12.83	26	8
Emergencies Situations or conditions requiring immediate intervention to avoid serious adverse results.	0	2.25	1	0
Rupture, Spontaneous Tear or break of an organ, vessel or other soft part of the body, occurring in the absence of external force.	0	2.25	1	0
Endometrioma An enlarged area of ENDOMETRIOSIS that resembles a tumor. It is usually found in the OVARY. When it is filled with old blood, it is known as a chocolate cyst.	0	5.33	8	0
Endometriosis A condition in which functional endometrial tissue is present outside the UTERUS. It is often confined to the PELVIS involving the OVARY, the ligaments, cul-de-sac, and the uterovesical peritoneum.	0	10.33	8	0
Chemical and Drug Induced Liver Injury, Chronic Liver disease lasting six months or more, caused by an adverse effect of a drug or chemical. The adverse effect may be caused by drugs, drug metabolites, chemicals from the environment, or an idiosyncratic response.	0	3.17	1	0
Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)	0	2.66	2	0
Complications, Neoplastic Pregnancy [description not available]	0	7.93	5	5
Sterility, Female [description not available]	0	5.39	4	1
Infertility, Female Diminished or absent ability of a female to achieve conception.	0	5.39	4	1
Disease Exacerbation [description not available]	0	3.13	4	0
Adenomyosis The extension of endometrial tissue (ENDOMETRIUM) into the MYOMETRIUM. It usually occurs in women in their reproductive years and may result in a diffusely enlarged uterus with ectopic and benign endometrial glands and stroma.	1	7.91	7	1
Infections, Coronavirus [description not available]	0	2.25	1	0
2019 Novel Coronavirus Disease [description not available]	0	2.25	1	0
Drug Withdrawal Symptoms [description not available]	0	2.25	1	0
Pneumonia, Viral Inflammation of the lung parenchyma that is caused by a viral infection.	0	2.25	1	0
Substance Withdrawal Syndrome Physiological and psychological symptoms associated with withdrawal from the use of a drug after prolonged administration or habituation. The concept includes withdrawal from smoking or drinking, as well as withdrawal from an administered drug.	0	2.25	1	0
Coronavirus Infections Virus diseases caused by the CORONAVIRUS genus. Some specifics include transmissible enteritis of turkeys (ENTERITIS, TRANSMISSIBLE, OF TURKEYS); FELINE INFECTIOUS PERITONITIS; and transmissible gastroenteritis of swine (GASTROENTERITIS, TRANSMISSIBLE, OF SWINE).	0	2.25	1	0
Myoma A benign neoplasm of muscular tissue. (Stedman, 25th ed)	0	4.24	3	1
Postpartum Amenorrhea [description not available]	0	11.24	13	9
Hypomenorrhea [description not available]	0	3.95	2	1
Amenorrhea Absence of menstruation.	0	11.24	13	9
Premenstrual Dysphoric Disorder A condition in which a woman suffers from severe depression, irritability, and tension before MENSTRUATION. Premenstrual dysphoric disorder (PMDD) may involve a wide range of physical or emotional symptoms, which are more severe and debilitating than those seen with premenstrual syndrome (PMS), and which include at least one mood-related symptom. Symptoms usually stop when, or shortly after, menstruation begins.	0	9.11	2	1
Liver Dysfunction [description not available]	0	2.31	1	0
Liver Diseases Pathological processes of the LIVER.	0	2.31	1	0
Affective Disorders [description not available]	0	2.31	1	0
Mood Disorders Those disorders that have a disturbance in mood as their predominant feature.	0	2.31	1	0
Carcinogenesis The origin, production or development of cancer through genotypic and phenotypic changes which upset the normal balance between cell proliferation and cell death. Carcinogenesis generally requires a constellation of steps, which may occur quickly or over a period of many years.	0	2.31	1	0
Fetal Macrosomia A condition of fetal overgrowth leading to a large-for-gestational-age FETUS. It is defined as BIRTH WEIGHT greater than 4,000 grams or above the 90th percentile for population and sex-specific growth curves. It is commonly seen in GESTATIONAL DIABETES; PROLONGED PREGNANCY; and pregnancies complicated by pre-existing diabetes mellitus.	0	2.15	1	0
Premature Rupture of Fetal Membranes [description not available]	0	2.15	1	0
Diabetes Mellitus, Gestational [description not available]	0	2.15	1	0
Fetal Membranes, Premature Rupture Spontaneous tearing of the membranes surrounding the FETUS any time before the onset of OBSTETRIC LABOR. Preterm PROM is membrane rupture before 37 weeks of GESTATION.	0	2.15	1	0
Diabetes, Gestational Diabetes mellitus induced by PREGNANCY but resolved at the end of pregnancy. It does not include previously diagnosed diabetics who become pregnant (PREGNANCY IN DIABETICS). Gestational diabetes usually develops in late pregnancy when insulin antagonistic hormones peaks leading to INSULIN RESISTANCE; GLUCOSE INTOLERANCE; and HYPERGLYCEMIA.	0	2.15	1	0
Pelvic Pain Pain in the pelvic region of genital and non-genital origin.	0	11.35	13	8
Overweight A status with BODY WEIGHT that is above certain standards. In the scale of BODY MASS INDEX, overweight is defined as having a BMI of 25.0-29.9 kg/m2. Overweight may or may not be due to increases in body fat (ADIPOSE TISSUE), hence overweight does not equal over fat.	0	2.15	1	0
Obesity A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY).	0	6.15	6	1
Premenstrual Tension A term used to describe the psychological aspects of PREMENSTRUAL SYNDROME, such as the indescribable tension, depression, hostility, and increased seizure activity in women with seizure disorder.	0	2.15	1	0
Premenstrual Syndrome A combination of distressing physical, psychologic, or behavioral changes that occur during the luteal phase of the menstrual cycle. Symptoms of PMS are diverse (such as pain, water-retention, anxiety, cravings, and depression) and they diminish markedly 2 or 3 days after the initiation of menses.	1	9.15	1	0
Leiomyosarcoma, Epithelioid [description not available]	0	3.99	4	0
Leiomyosarcoma A sarcoma containing large spindle cells of smooth muscle. Although it rarely occurs in soft tissue, it is common in the viscera. It is the most common soft tissue sarcoma of the gastrointestinal tract and uterus. The median age of patients is 60 years. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1865)	0	3.99	4	0
Leiomyomatosis The state of having multiple leiomyomas throughout the body. (Stedman, 25th ed)	0	9.69	9	0
Complication, Postoperative [description not available]	0	3.06	1	0
Postoperative Complications Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery.	0	3.06	1	0
Cancer of Endometrium [description not available]	0	3.73	3	0
Endometrial Neoplasms Tumors or cancer of ENDOMETRIUM, the mucous lining of the UTERUS. These neoplasms can be benign or malignant. Their classification and grading are based on the various cell types and the percent of undifferentiated cells.	0	3.73	3	0
Acute Disease Disease having a short and relatively severe course.	0	2.17	1	0
Cancer of Lung [description not available]	0	2.57	2	0
Lung Neoplasms Tumors or cancer of the LUNG.	0	2.57	2	0
Retroperitoneal Neoplasms New abnormal growth of tissue in the RETROPERITONEAL SPACE.	0	2.17	1	0
Central Serous Retinopathy [description not available]	0	2.17	1	0
Central Serous Chorioretinopathy A visual impairment characterized by the accumulation of fluid under the retina through a defect in the retinal pigment epithelium.	0	2.17	1	0
Recrudescence [description not available]	0	2.17	1	0
Atypical Endometrial Hyperplasia A benign form of endometrial hyperplasia with increased number of cells with atypia. The atypical cells are large and irregular and have an increased nuclear/cytoplasmic ratio. The risk of progression to endometrial carcinoma rises with the increasing degree of cell atypia.	0	4.82	2	1
Atrophy Decrease in the size of a cell, tissue, organ, or multiple organs, associated with a variety of pathological conditions such as abnormal cellular changes, ischemia, malnutrition, or hormonal changes.	0	2.17	1	0
Endometrial Hyperplasia Benign proliferation of the ENDOMETRIUM in the UTERUS. Endometrial hyperplasia is classified by its cytology and glandular tissue. There are simple, complex (adenomatous without atypia), and atypical hyperplasia representing also the ascending risk of becoming malignant.	0	4.82	2	1
Adverse Drug Event [description not available]	0	2.21	1	0
Drug-Related Side Effects and Adverse Reactions Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.	0	2.21	1	0
Peritoneal Carcinomatosis [description not available]	0	2.21	1	0
Peritoneal Neoplasms Tumors or cancer of the PERITONEUM.	0	2.21	1	0
Remission, Spontaneous A spontaneous diminution or abatement of a disease over time, without formal treatment.	0	2.21	1	0
Body Weight The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.	0	2.25	1	0
Menstruation, Painful [description not available]	0	2.25	1	0
Bleeding Between Periods [description not available]	0	3.44	2	0
Sex Disorders [description not available]	0	2.25	1	0
Multiple Primary Neoplasms [description not available]	0	2.25	1	0
Anxiety Feelings or emotions of dread, apprehension, and impending disaster but not disabling as with ANXIETY DISORDERS.	0	2.25	1	0
Depression Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders.	0	2.25	1	0
Dysmenorrhea Painful menstruation.	0	2.25	1	0
Dyspareunia Recurrent genital pain occurring during, before, or after SEXUAL INTERCOURSE in either the male or the female.	0	2.25	1	0
Metrorrhagia Abnormal uterine bleeding that is not related to MENSTRUATION, usually in females without regular MENSTRUAL CYCLE. The irregular and unpredictable bleeding usually comes from a dysfunctional ENDOMETRIUM.	0	3.44	2	0
Sexual Dysfunction, Physiological Physiological disturbances in normal sexual performance in either the male or the female.	0	2.25	1	0
Ectopic Pregnancy [description not available]	0	3	1	0
Pregnancy, Ectopic A potentially life-threatening condition in which EMBRYO IMPLANTATION occurs outside the cavity of the UTERUS. Most ectopic pregnancies (	0	3	1	0
Anovulation Suspension or cessation of OVULATION in animals or humans with follicle-containing ovaries (OVARIAN FOLLICLE). Depending on the etiology, OVULATION may be induced with appropriate therapy.	0	2.08	1	0
Muscle Contraction A process leading to shortening and/or development of tension in muscle tissue. Muscle contraction occurs by a sliding filament mechanism whereby actin filaments slide inward among the myosin filaments.	0	2.1	1	0
Abortion, Tubal [description not available]	0	7.52	4	4
Abortion, Spontaneous Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.	0	7.52	4	4
Bilateral Headache [description not available]	0	4.41	1	1
Ache [description not available]	0	4.41	1	1
Headache The symptom of PAIN in the cranial region. It may be an isolated benign occurrence or manifestation of a wide variety of HEADACHE DISORDERS.	0	4.41	1	1
Nausea An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.	0	5.72	2	1
Pain An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.	0	4.41	1	1
Genetic Predisposition [description not available]	0	3.03	1	0
Acute Post-operative Pain [description not available]	0	2.11	1	0
Pain, Postoperative Pain during the period after surgery.	0	2.11	1	0
Meigs Syndrome The triad of benign FIBROMA or other ovarian tumors with ASCITES, and HYDROTHORAX due to large PLEURAL EFFUSIONS.	0	7.11	1	0
Abortion, Recurrent [description not available]	0	2.53	2	0
Abortion, Habitual Three or more consecutive spontaneous abortions.	0	2.53	2	0
Fibromatosis [description not available]	0	2.13	1	0
Fibroma A benign tumor of fibrous or fully developed connective tissue.	0	2.13	1	0
Cells, Neoplasm Circulating [description not available]	0	2.13	1	0
Urination Disorders Abnormalities in the process of URINE voiding, including bladder control, frequency of URINATION, as well as the volume and composition of URINE.	0	2.13	1	0
Anemias, Iron-Deficiency [description not available]	0	2.13	1	0
Cerebral Ischemia [description not available]	0	2.13	1	0
Brain Ischemia Localized reduction of blood flow to brain tissue due to arterial obstruction or systemic hypoperfusion. This frequently occurs in conjunction with brain hypoxia (HYPOXIA, BRAIN). Prolonged ischemia is associated with BRAIN INFARCTION.	0	2.13	1	0
Anemia, Iron-Deficiency Anemia characterized by decreased or absent iron stores, low serum iron concentration, low transferrin saturation, and low hemoglobin concentration or hematocrit value. The erythrocytes are hypochromic and microcytic and the iron binding capacity is increased.	0	2.13	1	0
Cholangitis Inflammation of the biliary ductal system (BILE DUCTS); intrahepatic, extrahepatic, or both.	0	2.13	1	0
Endometrial Diseases [description not available]	0	2.15	1	0
Colicky Pain [description not available]	0	2.15	1	0
Uterine Diseases Pathological processes involving any part of the UTERUS.	0	2.15	1	0
Abdominal Pain Sensation of discomfort, distress, or agony in the abdominal region.	0	2.15	1	0
Polyps Discrete abnormal tissue masses that protrude into the lumen of the DIGESTIVE TRACT or the RESPIRATORY TRACT. Polyps can be spheroidal, hemispheroidal, or irregular mound-shaped structures attached to the MUCOUS MEMBRANE of the lumen wall either by a stalk, pedunculus, or by a broad base.	0	2.98	1	0
Complications, Pregnancy [description not available]	0	3.46	1	1
Hyperplasia An increase in the number of cells in a tissue or organ without tumor formation. It differs from HYPERTROPHY, which is an increase in bulk without an increase in the number of cells.	0	2.99	1	0
Diarrhea An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.	0	2.08	1	0
Emesis [description not available]	0	3	1	0
Vomiting The forcible expulsion of the contents of the STOMACH through the MOUTH.	0	3	1	0

ulipristal acetate

Description

Cross-References

Synonyms (79)

Research Excerpts

Overview

Effects

Treatment

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Roles (3)

Drug Classes (5)

Protein Targets (1)

Inhibition Measurements

Activation Measurements

Biological Processes (18)

Molecular Functions (15)

Ceullar Components (6)

Bioassays (10)

Research

Studies (353)

Market Indicators

Research Demand Index: 77.30

Study Types

Clinical Trials (64)

Trial Overview

Trial Outcomes

Shrinkage of Fibroids - Size of Fibroids

Short Form-36 and Uterine Fibroid Symptom Quality of Life

Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)

Frequencies of Subjects With Treatment Emergent Adverse Events

Impact on Menstrual Bleeding Patterns

Pregnancy Rate

Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13

Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist

Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist

Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)

Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)

Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)

Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids

Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)

Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)

Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)

Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses

Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4

Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses

Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1

Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1

Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2

Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1

Time to Absence of Bleeding on Treatment During Treatment Course 1

Time to Absence of Bleeding on Treatment During Treatment Course 2

Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment

Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment

Time to Absence of Bleeding on Treatment

Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Period

Change in the Length of the Index Menstrual Cycle From Baseline

Failure Rate

Percentage of Pregnancies Prevented (PPP)

Number of Participants With Follicle Rupture

Elimination Half-life of Serum LNG

Elimination Half-life of Serum UPA

Maximum Concentration of Serum LNG

Time to Maximum Concentration of Serum LNG

Time to Maximum Concentration of Serum UPA

Maximum Concentration of Serum UPA

Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration

Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration

Clearance of Serum LNG

Clearance of Serum UPA

Ovulation Status Measured by Weekly Serum Progesterone Levels

Number of Participants With Medication Side Effects by 30 Days

Number of Participants With Bleeding Cessation by Day 10

Number of Bleeding/Spotting Days With Use of Ulipristal Acetate as Measured by Daily Bleeding Diaries

Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.

Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.

Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.