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

Advance Provision of Postpartum Emergency Contraception and Its Effects on Reproductive Autonomy (clinicaltrials.gov) - P=N/A | N=75 | Completed | Sponsor: Northwestern University | Recruiting ➔ Completed

Trial completion

Hormonal Contraception after Use of Ulipristal Acetate as Emergency Contraception: A Systematic Review. (PubMed, Contraception) - "If a patient desires hormonal contraception after UPA, an interaction with UPA can be avoided by delaying initiation or resumption of hormonal contraception. The risk of pregnancy due to decreased effectiveness of UPA with immediate hormonal contraception should be balanced against the risk of subsequent pregnancy due to delay or non-start of hormonal contraception."

Journal • Review

The emerging role of progesterone receptor modulators in breast physiology, cancer prevention and treatment. (PubMed, BMJ Sex Reprod Health) - "UPA and mifepristone have the potential to revolutionise breast cancer prevention, screening and treatment. As protocols emerge, gynaecologists will be on the front lines as regards both identifying patients who may benefit from these medications and serving as interdisciplinary support in accessing these medicines."

Journal • Review • Breast Cancer • Gynecology • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • BRCA1 • PGR

Preoperative medical therapy before surgery for uterine fibroids. (PubMed, Cochrane Database Syst Rev) - "Pretreatment with gonadotropin-hormone-releasing analogues may reduce uterine and fibroid volume and probably increases preoperative haemoglobin levels, but probably also increases the number of adverse events. Blood transfusions and operation time during hysterectomy may be reduced, with fewer women experiencing postoperative morbidity. SPRMs, such as ulipristal acetate, seem to offer similar advantages: they probably reduce uterine volume and increase haemoglobin level before surgery, and may reduce fibroid volume and fibroid-related bleeding. However, replication of these studies is advised as the certainty of the evidence is moderate to low."

Clinical • Journal • Review • Gynecology • Hematological Disorders • Hepatology • Infertility • Liver Failure • Musculoskeletal Pain • Pain • Sexual Disorders • Solid Tumor • Uterine Leiomyoma • Women's Health • PGR

Hepatic Safety Considerations in the Use of Ulipristal Acetate for Symptomatic Uterine Fibroids. (PubMed, Ther Clin Risk Manag) - "While UPA had a unique place in the treatment of uterine fibroids, overly cautious regulatory measures due to exceedingly rare DILI incidences led to the withdrawal of its marketing authorization in most parts of the world. There is a need for an improved understanding of DILI mechanisms and causality assessments to aid in the development of more proportional regulatory responses, balancing patient safety and sustained access to effective innovative treatment."

Journal • Review • Gynecology • Hepatology • Liver Failure • Solid Tumor • Transplantation • Uterine Leiomyoma • Women's Health

Uses of ulipristal acetate beyond emergency contraception: a narrative review. (PubMed, Contraception) - "Access to UPA is crucial not only for EC but for the treatment of many other gynecologic and non-gynecologic conditions."

Journal • Review • Breast Cancer • Hepatology • Hormone Receptor Breast Cancer • Liver Failure • Novel Coronavirus Disease • Oncology • Solid Tumor • Uterine Leiomyoma • Women's Health

A Proof-of-Concept Study of Ulipristal Acetate for Early Medication Abortion. (PubMed, NEJM Evid) - "This study suggests that ulipristal acetate followed by misoprostol is an effective and acceptable medication abortion regimen with no reported serious adverse events. (This project is supported by the OPTions Initiative. The study registered as ISRCTN35625202.)."

Journal

Progesterone signaling in uterine fibroids: Molecular mechanisms and therapeutic opportunities. (PubMed, Life Sci) - "Clinical trials have demonstrated the effectiveness of SPRMs like mifepristone, asoprisnil, and ulipristal acetate in reducing fibroid size and symptoms, though concerns about safety, particularly with long-term use, remain. Newer SPRMs, such as vilaprisan, show promise, but further research is necessary to assess the long-term safety and effectiveness. This review discusses the mechanisms by which progesterone contributes to fibroid growth and examines clinical effectiveness of SPRMs as potential treatments for uterine fibroids."

Journal • Review • Gynecology • Oncology • Solid Tumor • Uterine Leiomyoma • Women's Health • PGR

Selective progesterone receptor modulators for the treatment of dysmenorrhea: an update. (PubMed, Expert Opin Pharmacother) - "The present review examines the development of the clinical trials and observational studies done with the different SPRMs for the treatment of dysmenorrhea in patients with uterine diseases. Mifepristone, telapristone acetate and vilaprisan have antagonistic activity on PRs, while ulipristal acetate and asoprisnil have both potent antagonist and partial agonist effects.While no studies have been done on primary dysmenorrhea, the different SPRMs have been studied in the treatment of endometriosis, adenomyosis and uterine fibroid-related dysmenorrhea."

Journal • Review • Endometriosis • Gynecology • Pain • Solid Tumor • Uterine Leiomyoma • Women's Health

New Data on Ulipristal Acetate and Misoprostol for Medication Abortion - A Step Forward? (PubMed, NEJM Evid) - No abstract available

Journal

Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception (clinicaltrials.gov) - P3 | N=980 | Not yet recruiting | Sponsor: The University of Hong Kong

New P3 trial

Current and future management of uterine fibroids – a pilot survey of UK gynaecologists (ESGE 2024) - "The newer GnRH- antagonists were available at 75.9% hospitals, whilst 1.9% reported that they had access to Esmya.Just 9% of respondents would not offer myomectomy to a woman whose family was complete.15% surgeons reported that they routinely hysteroscope their patients at the time of myomectomy...Over 50% respondents were female, representing a change in the gynaecology workforce.The results of this work are limited by the small sample size. We intend to edit the questionnaire and repeat the survey to encourage better participation."

Gynecologic Cancers • Gynecology • Oncology • Solid Tumor • Uterine Leiomyoma • Women's Health

Promising selective progesterone receptor modulators: what's new in female contraception? (PubMed, Expert Opin Investig Drugs) - "Selective progesterone receptor modulators (SPRMs), such as mifepristone and ulipristal acetate (UPA), have demonstrated high efficacy and safety as single dose treatments for medication abortion and emergency contraception (EC). However, current restrictions on UPA limit longer term use. Perhaps other SPRMs without hepatic impacts may emerge to fill this need."

Journal • Review • Hepatology • Liver Failure • Obstetrics

White matter integrity upon progesterone antagonism in individuals with premenstrual dysphoric disorder: A randomized placebo-controlled diffusion tensor imaging study. (PubMed, Prog Neuropsychopharmacol Biol Psychiatry) - P2 | "The main findings suggest that SPRM treatment did not impact white matter microstructure compared with placebo. However, secondary exploratory analyses yielded between-group differences after treatment, which call for further investigation on the tracts potentially impacted by progesterone antagonism."

Clinical • Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry

Dual Au/Ag Catalyzed Regiospecific Intramolecular Hydroacyloxylation and Hydroalkoxylation of Unactivated Geminal-Substituted Olefins. (PubMed, Chem Asian J) - "This method has been effectively applied for late-state functionalization to produce bioactive natural products such as rumphellaone A, mycophenolate, and (-)-ambrox. The successful gram-scale synthesis of the anticonvulsant, hypnotic drug (±)-ethyl phenyl butyro lactone (EPBL), (±)-Boivinianin A and the ability to synthesize challenging spiro and bicyclic lactone underscores the synthetic potential of this methodology. Mechanistic insights into gold-silver catalyzed lactonization of olefins have also been discussed."

Journal

Impact of Regulatory Interventions on Ulipristal Acetate 5 mg (Esmya) Use in Spain: An Interrupted Time-Series Analysis. (PubMed, Pharmacoepidemiol Drug Saf) - "Despite RMM had an immediate strong impact on UPA use, the last segment upward trend in the long-term might have been affected by the lack of comparable therapeutic alternatives. Further studies should be performed to confirm the increase trend observed and analyze subsequent measures and additional data."

Journal • Hepatology • Liver Failure

Premenstrual Dysphoric Disorder: a systematic review of treatments with antidepressants and contraceptives (NAMS 2024) - "RoB2 tool used for risk of bias anaylsis Seventeen placebo-controlled RCTs with antidepressants were identified: seven with sertraline, three with fluoxetine, one with venlafaxine, five with paroxetine, and 1 with escitalopram...Six studies with contraceptives were found: one with levonorgestrel and ethinyl estradiol, one with ulipristal acetate, and 4 with drospirenone and ethinyl estradiol... Antidepressants have the most and best quality evidence for use in PMDD. Their effect appears to emerge quickly and at lower doses than those commonly used for depression or anxiety, allowing for intermittent use, during luteal phase. Use only during symptomatic phase showed uncertain results, requiring further clarification."

Review • CNS Disorders • Depression • Mood Disorders • Psychiatry

Is there still a place for progesterone receptor modulators in chronic use ? (PubMed, Rev Med Liege) - "First identified with mifepristone, they are now represented by ulipristal acetate (UPA), used for emergency contraception and uterine fibroids. Despite certain concerns, SPRMs offer promising prospects in gynecological pathologies, opening up new therapeutic avenues to improve women's health and quality of life. This article describes the case of a patient with peritoneal leiomyomatosis for whom UPA significantly alleviated symptoms, reduced disease progression and improved quality of life, even allowing a pregnancy."

Journal • Breast Cancer • Endometriosis • Gynecology • Hepatitis C • Hormone Receptor Breast Cancer • Liver Failure • Oncology • Solid Tumor • Uterine Leiomyoma • Women's Health

Hormonal methods for emergency contraception. (PubMed, Best Pract Res Clin Obstet Gynaecol) - "Ulipristal acetate (UPA) and levonorgestrel (LNG) are the recommended oral methods...Mifepristone can also be used for EC but its availability is limited to few countries...Hormonal contraception can be quickstarted immediately following LNG, or five days following UPA. LNG-releasing intrauterine devices and cyclo-oxygenase inhibitors are promising options for EC to be further studied."

Journal • Review • Long-acting Reversible Contraceptives

Role of inflammation and immune response in the pathogenesis of uterine fibroids: Including their negative impact on reproductive outcomes. (PubMed, J Reprod Immunol) - "Hormonal treatments using gonadotropin releasing hormone analogs and the selective progesterone receptor modulator ulipristal acetate significantly shrink UFs and improve UF-related symptoms. These compounds can regulate local inflammation in UFs and adjacent myometrium. Controlling and improving local inflammation caused by UFs may represent a novel therapeutic strategy for UFs and potentially improve reproductive outcomes in women with symptomatic UFs."

Journal • Review • Gynecology • Hematological Disorders • Inflammation • Oncology • Solid Tumor • Uterine Leiomyoma • Women's Health • IL10 • IL6 • PGR • TGFB1 • TNFA

Double dosing ulipristal acetate emergency contraception for individuals with obesity: a randomised crossover trial. (PubMed, BMJ Sex Reprod Health) - "A standard 30 mg dose of UPA is sufficient to delay ovulation regardless of BMI or weight. Results of our study do not support dose adjustment for body size."

Journal • Genetic Disorders • Obesity

Ovarian Function With ENG Implant and UPA Use (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: University of Utah | Active, not recruiting ➔ Completed

Trial completion • Long-acting Reversible Contraceptives

Safety of Progestogen Hormonal Contraceptive Methods during Lactation: An Overview. (PubMed, Clin Pract) - "Based on published scientific reports, progestogen hormonal contraceptives can be considered a relatively safe solution for women desiring to continue feeding their infant with their milk while using hormonal contraception. It is important to seek guidance on selecting the best contraception method based on the latest medical knowledge, tailored to the individual needs and clinical circumstances of each woman and place of residence. A woman should always be informed of the potential risks of such a treatment and then allowed to make her own decision based on the knowledge received from a specialist."

Journal • Review

In Vitro Human Endometrial Cells and In Vivo Rat Model Studies Suggest That Ulipristal Acetate Impacts Endometrial Compatibility for Embryo Implantation. (PubMed, Arch Med Res) - "These results support that UPA as an emergency contraceptive might have post-fertilization effects that may affect embryo implantation."

Journal • Preclinical

Emergency contraception - A narrative review of literature. (PubMed, Eur J Obstet Gynecol Reprod Biol) - "Taking emergency contraception can result in various adverse effects, therefore it should be introduced after thorough analysis of woman's medical history, including gynecological and obstetric history and potential contraindications. Additionally, the patient should receive detailed information about the drug mechanism of efficacy and potential adverse effects."

Journal • Review • Long-acting Reversible Contraceptives • Obstetrics