Esmya (ulipristal acetate) / ASKA Pharma, Gedeon Richter, AbbVie, Perrigo Company - LARVOL DELTA

NL62638.029.18: Ulipristal versus surgery for symptomatic uterine fibroids (clinicaltrialsregister.eu) - P4 | N=164 | Recruiting | Sponsor: Amsterdam UMC Stichting | Not yet recruiting ➔ Recruiting

Enrollment open • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Regulatory discrepancies and patient-safety risks from the continued marketing of withdrawn medicines in Ecuador, Colombia, and Peru (2014-2025). (PubMed, Drug Metab Pers Ther) - "Substantial misalignment persists between international and Andean regulatory decisions. The continued regulatory authorization of withdrawn medicines highlights weaknesses in pharmacovigilance and transparency, underscoring the urgent need for regional harmonization and public disclosure of regulatory actions."

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Emergency contraception (ISGE 2026) - "The recommended options for oral EC are ulipristal acetate 30mg and levonorgestrel 1.5 mg...Mifepristone is also effective for EC, but a registered EC product is only available in a few countries...Knowledge on the mechanisms of action of ECP could help to optimize their use and give realistic expectations on their effectiveness. We have utilized this knowledge in the development of new ECP or flexible on demand options with wider window of action resulting in increased efficacy."

Long-acting Reversible Contraceptives

Bioprospection of Piliostigma thonningii ethanol extract for anti-fibroid activity via molecular docking and in vivo hormonal evaluation in female wistar rats. (PubMed, J Steroid Biochem Mol Biol) - "Among the top-ranked compounds, cyclopropaneoctanal-2-octyl exhibited favourable predicted binding interactions with key catalytic residue for PR (CYS891 and THR894) and ER catalytic residue (HIS524) comparable to the reference ligands ulipristal acetate and estrogen. Drug-likeness and ADMET prediction suggested that this compound possess acceptable pharmacokinectic properties and dynamic stability. These findings indicate that P. thonningii extract exerts anti-fibroid effects in vivo while in silico analysis provide mechanistic hypotheses regarding the potential contribution of the individual compounds to estrogen and progesterone receptor modulation."

Journal • Preclinical • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health • ER • PGR

Mammogram Pretreatment With Ulipristal Acetate (clinicaltrials.gov) - P2 | N=26 | Not yet recruiting | Sponsor: OHSU Knight Cancer Institute

New P2 trial

Ulipristal acetate emergency contraception access and dispensing in Alberta, Canada from 2015 to 2023. (PubMed, Contraception) - "Ulipristal acetate use in Alberta, Canada steadily increased since approval, with equitable rural and urban access. First-year uptake appeared to have a lag compared to other new medications, suggesting adoption barriers. Clinician awareness, patient education, and policy support remain essential to ensure equitable access to this highly effective emergency contraception."

Journal

Current Treatment for Symptomatic Uterine Fibroids: Available Evidence and Therapeutic Dilemmas. (PubMed, Obstet Gynecol Surv) - "Current treatments for symptomatic fibroids included in this review are uterine artery embolization, magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU), laparoscopic radio-frequency ablation, transcervical radiofrequency ablation, ulipristal acetate intermittent treatment (four 12-week treatment regimens) and oral gonadotropin-releasing hormone receptor antagonists with add-back therapy...Each of these options should be considered in the context of patient desires and symptom severity, as well as future reproductive plans. Future research should focus on comparing methods to find what is most effective as well as studying reproductive outcomes for each method."

Journal • Review • Anesthesia • Back Pain • CNS Disorders • Depression • Gynecology • Mood Disorders • Musculoskeletal Pain • Oncology • Pain • Psychiatry • Sexual Disorders • Solid Tumor • Uterine Leiomyoma • Women's Health

Management of Bleeding Irregularities during Contraceptive Implant Use: A Systematic Review. (PubMed, Contraception) - "Implications: Patients experiencing bothersome bleeding irregularities during contraceptive implant use may be offered different options to manage bleeding and improve their satisfaction. More data are needed on the effectiveness of specific interventions (drugs, regimens, and repeat dosing) and patient satisfaction outcomes."

Clinical • Journal • Review • Long-acting Reversible Contraceptives

The Use and Effectiveness of Different Emergency Contraception Methods Among Adolescent Girls and Young Women in a Greek Clinic: A Cross-Sectional, Comparative, Observational Study. (PubMed, Clin Pract) - "Emergency contraception pills contain either levonorgestrel (a single 1.5 mg dose, effective within 72 h) or ulipristal acetate (a single 30 mg dose, effective within 120 h), both of which are most effective when taken as soon as possible after unprotected intercourse...However, Christians were significantly more likely to use emergency contraception due to missed contraceptive doses (20.9% vs. 6.7%, p = 0.004) or the failure to take a progesterone-only pill (19.1% vs. 3.3%, p = 0.001)... Both religious and individual sociodemographic factors affect not only the choice of emergency contraception but also the urgency with which the emergency contraception is used. Interventions aimed at improving contraception education, addressing partner-related challenges, and promoting timely access could improve reproductive health outcomes."

Journal • Observational data • Long-acting Reversible Contraceptives

Exploring Postpartum Use of Advance Provision of Ulipristal Acetate and Its Promotion of Reproductive Autonomy. (PubMed, O G Open) - "Postpartum patients choosing lower-efficacy contraception valued advance provision of ulipristal acetate and reflected on ulipristal acetate as a user-controlled option, bolstering reproductive autonomy. Advance provision of ulipristal acetate can be a useful intervention to increase contraceptive access for postpartum patients before discharge."

Journal

Systematic review of interest-holder perceptions of pharmacist-prescribed ulipristal acetate emergency contraception. (PubMed, J Am Pharm Assoc (2003)) - "Pharmacist-prescribed UPA can enhance access to EC. Education, reimbursement, and support barriers must be addressed, in addition to legislation expansion, to enhance implementation."

Journal • Review

Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg (clinicaltrials.gov) - P4 | N=532 | Terminated | Sponsor: Kimberly Myer | N=1200 ➔ 532 | Unknown status ➔ Terminated; We weren't seeing as many pregnancies we initially thought.

Enrollment change • Trial termination

CCN013B: Study of the Safety and Efficacy of Ulipristal Acetate (UPA) Used Daily as a Contraceptive (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Premier Research | N=300 ➔ 0 | Suspended ➔ Withdrawn

Enrollment change • Trial withdrawal

Effects of female hormone withdrawal and ulipristal acetate on MED12 mutation positive and negative uterine leiomyomas using a xenograft model. (PubMed, Sci Rep) - "Gene ontology and pathway analyses of the differentially expressed genes of the xenograft tumors suggested that regression occurred by different mechanisms in the two subtypes. Our results also suggested, for the first time, that UPA caused SMC death by a mechanism other than progesterone receptor inhibition."

Journal • Preclinical • Oncology • Solid Tumor • Transplantation • Uterine Leiomyoma • MED12

Pricing of oral emergency contraception by German community pharmacies - a nationwide mystery caller investigation. (PubMed, Med Pharm Rep) - "The "morning after pill" (oral emergency contraception (EC)) with the active ingredients ulipristal acetate (UPA) and levonorgestrel (LNG) may only be dispensed by community pharmacies (CPs) in Germany...The price of UPA preparations is much higher than that of LNG preparations. High price levels and wide price ranges, especially for UPA preparations, could restrict access to oral EC."

Journal • Pricing

Efficacy and safety of emergency contraception interventions: a systematic review and Bayesian network meta-analysis. (PubMed, BMJ Sex Reprod Health) - "Although the efficacy of LNG-COX was confirmed by high-certainty evidence, large-scale validation trials are required before it can be recommended clinically. Owing to within-study bias and imprecision, large RCTs are strongly recommended to assess the efficacy of ECs for interventions without direct comparisons."

Journal • Retrospective data • Long-acting Reversible Contraceptives

Enhancing Access to Emergency Contraception: Results from a No-Cost Program in Utah. (PubMed, Contraception) - "This study supports removing cost and access barriers to emergency contraception, showing high demand for ulipristal acetate, and sustained use when offered without provider visits. This model demonstrates an innovative and feasible approach to deliver equitable access across diverse populations and regions via electronic portals and mail delivery systems."

Journal

Anti-progestin therapy targets hallmarks of breast cancer risk. (PubMed, Nature) - P2 | "Here, in the Breast Cancer-Anti-Progestin Prevention Study 1 (BC-APPS1; NCT02408770 ), we assessed whether progesterone receptor antagonism with ulipristal acetate for 12 weeks reduces surrogate markers of breast cancer risk in 24 premenopausal women...Culture of primary human breast epithelial cells in a stiff environment increased luminal progenitor activity, which was antagonized by anti-progestin therapy, strengthening this mechanistic link. This study offers a template for biologically informed early-phase therapeutic cancer prevention trials and demonstrates the potential for premenopausal breast cancer prevention with progesterone receptor antagonists through stromal remodelling and luminal progenitor suppression."

Journal • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

Safety of repeated use of emergency contraceptive pills in the same menstrual cycle: a systematic review. (PubMed, BMJ Sex Reprod Health) - "Evidence on the safety of repeated ECP use is limited and of very low certainty, but overall does not suggest safety concerns."

Journal • Review

EXPERIENCE IN THE MANAGEMENT OF UTERINE FIBROIDS WITH ULIPRISTAL ACETATE IN MEXICAN PATIENTS (FIGO 2025) - "This study describes the first experience in a Mexican-population. As shown, the efficacy of UPA in the first week of treatment of UF bleeding is confirmed with a high proportion of patients developing amenorrhoea. The average reduction in UF with a single cycle of treatment also appears significant."

Clinical • Gynecology • Hematological Disorders • Infertility • Sexual Disorders • Solid Tumor • Uterine Leiomyoma • Women's Health

Assessment of Hepatic Safety of Ulipristal Acetate in Korean Women with Uterine Fibroids: A Real-World Study Using Biochemical Markers. (PubMed, J Clin Med) - " UPA use in Korean women was associated with mild, subclinical elevations in liver enzymes and fatty liver index, but not with clinically significant hepatotoxicity. These findings support vigilant hepatic monitoring during UPA therapy, while contextualizing its risk as low in this population."

Journal • Real-world evidence • Gynecology • Hepatology • Liver Failure • Solid Tumor • Uterine Leiomyoma • Women's Health

Medical treatment of fibroids: FIGO best practice guidance. (PubMed, Int J Gynaecol Obstet) - "The previously approved therapy with ulipristal acetate had to undergo extensive restrictions because of safety concerns. These include combined oral contraceptives, oral progestins, the levonorgestrel-releasing intrauterine system (LNG-IUS), and tranexamic acid. Although not specifically approved for the treatment of fibroids, these agents can reduce the intensity of bleeding in cases of heavy menstrual bleeding and thereby improve symptoms and lead to an improved quality of life for the patients."

Journal • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Premium: Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting (clinicaltrials.gov) - P=N/A | N=1527 | Completed | Sponsor: PregLem SA | Active, not recruiting ➔ Completed

Trial completion • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Effect of emergency contraception (ulipristal acetate) on growth, sexual differentiation, and reproduction in Oryzias latipes. (PubMed, Environ Toxicol Pharmacol) - "This study is the first to examine the effects of UPA on growth, gonadal sex differentiation, and reproduction in fish. Our results indicate that UPA has no effect on Japanese medaka and is thus an ecosystem-friendly emergency contraceptive."

Journal • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Ulipristal acetate for medical abortion: did we really need to create a 'monster'? (PubMed, Eur J Contracept Reprod Health Care) - No abstract available

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