The purpose of this study is to learn more about why some people are at greater risk for oral emergency contraceptive failure while others are not. The investigators want to learn if genetic differences impact the risk of emergency contraception failure.

Start Date09 Jan 2023

Sponsor / Collaborator

Oregon Health & Science University

100 Clinical Results associated with Ulipristal Acetate

100 Translational Medicine associated with Ulipristal Acetate

100 Patents (Medical) associated with Ulipristal Acetate

974

Literatures (Medical) associated with Ulipristal Acetate

01 Jan 2025·Progress in Neuro-Psychopharmacology and Biological Psychiatry

White matter integrity upon progesterone antagonism in individuals with premenstrual dysphoric disorder: A randomized placebo-controlled diffusion tensor imaging study

Article

Author: Sundström-Poromaa, Inger ; Gu, Xuan ; Lanzenberger, Rupert ; Hahn, Andreas ; Comasco, Erika ; Kaltsouni, Elisavet ; Wikström, Johan

BACKGROUNDPremenstrual dysphoric disorder (PMDD) is a depressive disorder triggered by fluctuations of progesterone and estradiol during the luteal phase of the menstrual cycle. Selective progesterone receptor modulation (SPRM), while exerting an antagonistic effect on progesterone and maintaining estradiol on moderate levels, has shown beneficial effects on the mental symptoms of PMDD. Progesterone is also known for its neuroprotective effects, while synthetic progestins have been suggested to promote myelination. However, the impact of SPRM treatment on white matter microstructure is unexplored.METHODSDiffusion tensor imaging was employed to collect data on white matter integrity in patients with PMDD, before and after treatment with ulipristal acetate (an SPRM) or placebo, as part of a double-blind randomized controlled-trial. Tract based spatial statistics were performed to investigate SPRM treatment vs. placebo longitudinal effects on fractional anisotropy (FA), mean diffusivity (MD), radial diffusivity (RD), and axial diffusivity (AD), on the whole white matter skeleton.RESULTSVoxel-wise analyses indicated no change over time in any white matter microstructure metrics in individuals treated with SPRM versus placebo. Improvement in PMDD symptoms did not correlate with changes in white matter microstructure. In secondary, exploratory, cross-sectional comparisons during treatment, the SPRM group displayed lower FA and higher MD, RD, and AD than the placebo group in several tracts.CONCLUSIONThe 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 TRIAL REGISTRATIONEUDRA-CT 2016-001719-19; "Selective progesterone receptor modulators for treatment of premenstrual dysphoric disorder. A randomized, double-blind, placebo-controlled study."; https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001719-19/SE.

01 Dec 2024·Archives of Medical Research

In Vitro Human Endometrial Cells and In Vivo Rat Model Studies Suggest That Ulipristal Acetate Impacts Endometrial Compatibility for Embryo Implantation

Article

Author: Díaz, Lorenza ; Hernández-Silva, Gabriela ; Larrea, Fernando ; Vega, Claudia Cecilia ; Chirinos, Mayel ; García-Uribe, Pablo Ángel ; Barrera, David ; Morales, Angélica ; García-Becerra, Rocío ; Ordaz-Rosado, David ; Hernández-Pando, Rogelio ; García-Quiroz, Janice

BACKGROUNDUlipristal acetate (UPA) and levonorgestrel are used as emergency hormonal contraceptives. Although both are highly effective in preventing pregnancy, UPA shows efficacy even when taken up to 120 h after unprotected sexual intercourse.AIMSTo investigate whether the mechanism of UPA's contraceptive action involves post-fertilization effects.METHODSIn vitro and in vivo studies using cultured human endometrial cells and a pre-clinical rat model.RESULTSEndometrial cells treated with UPA showed changes in the expression of receptivity gene markers and a significant decrease in trophoblast spheroids attached to the cultured cells. In addition, administration of UPA to female unmated rats decreased the expression of implantation-related genes in the endometrium and inhibited the number of implantation sites in the mated group compared to the non-treated group.CONCLUSIONSThese results support that UPA as an emergency contraceptive might have post-fertilization effects that may affect embryo implantation.

01 Dec 2024·Best Practice & Research Clinical Obstetrics & Gynaecology

Hormonal methods for emergency contraception

Review

Author: Lo, Sue Seen Tsing ; Cameron, Sharon Tracey ; Li, Raymond Hang Wun

The World Health Organization includes oral emergency contraception (EC) in the list of essential medicines. Ulipristal acetate (UPA) and levonorgestrel (LNG) are the recommended oral methods. UPA has superior efficacy and a comparable side effect profile compared with LNG. Both work by inhibiting or delaying ovulation, so that sperm present in the reproductive tract will have lost their fertilising ability by the time the oocyte is eventually released. Neither LNG nor UPA at the EC doses have significant effects on the endometrium and are unable to prevent implantation. Mifepristone can also be used for EC but its availability is limited to few countries. LNG is less effective in women with a body mass index over 26 kg/m² or weight over 70 kg. 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.

News (Medical) associated with Ulipristal Acetate

27 Aug 2024

·www.prnewswire.com

ScaleReady announces the inaugural G-Rex® Grant has been awarded to Stanford Medicine Laboratory for Cell and Gene Medicine

ST. PAUL, Minn., Aug. 27, 2024 /PRNewswire/ -- ScaleReady™, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH) and CellReady™, today announced that Dr. Steve Feldman, Scientific Director and Site Head of Stanford Medicine's Laboratory for Cell and Gene Medicine (LCGM), has been awarded the inaugural G-Rex® Grant. Dr. Feldman's $300,000 G-Rex Grant will enable expeditious development of Stanford Medicine's LCGM's G-Rex platform for CAR-T cell therapy manufacturing, which will be offered to internal investigators and external developers who are seeking its development and manufacturing services. "Stanford's LCGM anticipates a need to support a greater number of clinical trials and the G-Rex Grant will be used to help meet that need," said Dr. Feldman. "We are honored to award the inaugural G-Rex Grant to Dr. Feldman and his team at Stanford Medicine LCGM. Stanford University is a world-class institution with faculty who have a reputation for innovative and ground-breaking achievements. Their work aligns with Wilson Wolf's mission of bringing hope to cancer patients, one G-Rex at a time" said John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex. As part of the G-Rex Grant, Stanford Medicine LCGM will deploy their G-Rex-centric manufacturing process in an upcoming Phase 1 trial for GPC2+ pediatric neuroblastoma and medulloblastoma. Previously, the FDA had recommended sponsors develop and implement potency assays earlier in the clinical trial process. With that objective, Stanford Medicine LCGM plans to implement Bio-Techne's leading automated multiplexing immunoassay platform, Ella™, as a potency assay for final drug product release. Furthermore, Stanford Medicine LCGM will collaborate with CellReady, the world's first and only G-Rex based contract development and manufacturing organization (CDMO), to leverage their proven capacity to quickly create G-Rex master batch records that establish manufacturing simplicity, efficiency, and repeatability. Additionally, Stanford Medicine LCGM plans to further develop a novel technology (developed by Wilson Wolf) that enables closed-system T cell purification to be done directly in a G-Rex device, without the need for expensive ancillary equipment. ScaleReady's G-Rex Grant Program is a $20M initiative to advance the state of cell and gene-modified cell therapy (CGT) development and manufacturing by awarding individual Grant Awards worth up to $300,000. G-Rex Grant Recipients also gain access to exclusive support from ScaleReady's growing consortium of G-Rex Grant Partners who bring best-in-class tools and technologies as well as unparalleled knowledge and expertise in the areas of cGMP manufacturing, quality and regulatory affairs, CGT business operations, and more. About ScaleReady ScaleReady provides the field of cell and gene-modfied cell therapy (CGT) with a G-Rex centric manufacturing platform that enables the world's most practical, flexible, scalable, and affordable CGT drug product development and manufacturing. The G-Rex manufacturing platform is currently used by a rapidly growing list of over 800 organizations and is producing drug products for approximately 50% of CGT clinical trials as well as 4 commercially approved CGT drugs. CGT entities relying on the breadth and scope of ScaleReady's expertise can expect to save years of time and millions of dollars on the path to CGT commercialization. For more information about the ScaleReady G-Rex® Grant Program, please contact [email protected]. About Wilson Wolf Manufacturing Wilson Wolf () is dedicated to simplifying cell and gene-modified cell (CGT) therapy research, process development, and manufacturing. This is being accomplished through its scalable G-Rex® technology, which is used throughout the world in CGT applications ranging from basic research to commercial drug production. Wilson Wolf's mission is to create hope for cancer patients, one G-Rex® device at a time. About Bio-Techne Corporation Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex® Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing. For more information on Bio-Techne and its brands, please visit or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube. Contact: David Clair, Vice President, Investor Relations & Corporate Development [email protected] 612-656-4416 About CellReady LLC CellReady is the world's first and only G-Rex® centric contract development and manufacturing organization (CDMO) specializing in G-Rex® based cell and gene-modified cell therapy development and manufacturing. The company offers a wide range of services to support the development and commercialization of these therapies. CellReady's mission is to create hope for cancer patients, one G-Rex® process at a time. SOURCE Bio-Techne Corporation

Cell TherapyImmunotherapyGene Therapy

08 Aug 2024

·www.biospace.com

Gameto Expands Executive Team with the Addition of Teri Loxam as Chief Financial Officer

NEW YORK, April 28, 2023 /PRNewswire/ -- Gameto, a female-led biotech company developing therapies to improve the female reproductive journey, today announced the expansion of its executive team with the appointment of Teri Loxam as its first Chief Financial Officer. In this new role, Teri will oversee Gameto's financial function, as well as play a key role in overall company strategy. "Teri is a proven CFO and an impressive female leader, whose decades of experience will immediately add value to our company," said Dina Radenkovic, co-founder and CEO of Gameto. "Her depth of knowledge in capital markets and financing in the biotechnology and pharmaceutical industries comes at an exciting time for the company as we work on clinical development and go-to-market strategy for our lead program, Fertilo, to make the IVF process shorter, safer and more effective for women. Teri's personal passion for women's health is extremely important to us as we continue to grow." Teri joins Gameto with over 20 years of diverse experience in strategy, investor relations and finance across the pharmaceutical, biotech, and TMT industries. Prior to joining Gameto, Teri was Chief Operating Officer & Chief Financial Officer at Kira Pharmaceuticals, a clinical-stage biotech company developing transformative therapies for people with complement-mediated diseases. There, she built financial and operational functions across the U.S. and China locations to get the company public-ready. Prior to Kira, Teri served as CFO of SQZ Biotechnologies, a novel cell therapy company developing treatments for cancer, infectious disease and other serious conditions, where she raised over $200M, including taking the company public in October 2020. Prior to joining SQZ, Teri held various positions at Merck, IMAX Corporation, and Bristol-Myers Squibb. Teri is also a member of the board of directors and audit chair of Vaxcyte, Inc. and Cardiol Therapeutics, Inc. She has a B.S. in Biology from the University of Victoria, B.C. Canada and an MBA from the University of California, Irvine. "Gameto's highly innovative platform and dedication to improve and support women's health is impressive," said Teri Loxam, Chief Financial Officer of Gameto. "I am eager to work with a talented team of professionals who are passionate about transforming the traditional IVF processes and advancing developments for women." Teri's appointment is one of many new senior hires this year. Gameto recently appointed Jean-Pierre Gotteland as Head of Development to the management team. Prior to joining Gameto, Jean-Pierre was Chief Scientific Officer and Head of R&D at ObsEva SA, a clinical-stage biotech company developing innovative women's reproductive health therapeutics. There, he led the development and approval of linzagolix, for uterine fibroids, and brought to clinical trials nolasiban, for increasing live birth rate following IVF. Jean-Pierre also served as Chief Development Officer at PregLem SA where he led the development and EU approval of ulipristal acetate for uterine fibroids and infertility. Prior to joining PregLem, Jean-Pierre held various R&D positions at Serono, a world-leading pharmaceutical company before its acquisition by Merck KgA. Jean-Pierre will facilitate clinical development of Gameto's lead program, Fertilo. These new senior hires expand the multidisciplinary team of stem cell engineers, computational biologists, embryologists and physicians Gameto has brought together. About Gameto Based in New York and Madrid, Gameto is a biotechnology company using cell engineering to develop therapeutics for diseases of the female reproductive system. Gameto brings together an experienced scientific management team with vision and passion to develop a product offering that will support women throughout their reproductive journey. Gameto is currently working on its first program, Fertilo, a product for IVF and egg freezing, aiming to make the process shorter, safer and more effective. The preclinical studies for Fertilo found that it can increase egg yield per cycle and maturation for both conventional and reduced stimulation cycle. Gameto is currently conducting preclinical studies with partners Inception Fertility, Spring Fertility, Extend Fertility, RMA, Pozitivf, Ovation Fertility, ReproART, Clinica Tambre, and Hospital Ruber Internacional, Eugin Group. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and leader in the fertility space Martin Varsavsky as Chairman. For more information, go to gametogen.com or follow us on Twitter and Instagram @gametogen.

Executive ChangeDrug Approval

26 Apr 2024

·www.prnewswire.com

BIO-TECHNE AND NOVOMOL-Dx ANNOUNCE POINT-OF-CARE OCULAR BIOMARKER ASSAY

MINNEAPOLIS, April 26, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) and Novomol-Dx, a molecular diagnostics company, are pleased to announce the development of Bio-Marker Pathfinder (BMP), a first of its kind ocular biomarker kit, as a point-of-care application. Novomol-Dx is a molecular diagnostics company focused on commercializing tests for the diagnosis and treatment of ophthalmic diseases utilizing biomarkers discovered over the last decade at Narayana Nethralaya Foundation, in association with Grow Laboratories & Narayana Nethralaya, a specialty eye care hospital chain in Bangalore India. The BMP kit runs on Bio-Techne's Ella™, a benchtop automated immunoassay platform leveraging Bio-Techne's R&D Systems branded reagents to deliver accurate, reliable, and highly reproducible data in less than 90 minutes. Ella's microfluidic-based cartridges with separate channels enable precision multiplexing in a hands-free system, making it ideal for diagnostic clinical use. Novomol-Dx relied on a proprietary algorithm to develop the normative data, disease-associated data, and AI-based predictive algorithms for ocular surface and retinal conditions. The complete solution is branded as BioM-Pathfinder. The novel applications for the BMP kit are in Dry Eye Disease, Diabetic Retinopathy and patient stratification or monitoring associated with ocular surgeries and treatments. "The BMP kit's ability to produce clinically actionable data using tear samples is a game-changer for the diagnosis of these conditions. This kit fills a significant unmet need, with an estimated 15 million suffering from various ophthalmic diseases in India. Beyond ocular applications, we believe the underlying technology is potentially relevant for disease-associated diagnostic or prognostic applications in the future," stated Dr. Rohit Shetty, Chairman at Narayana Nethralaya. "There is a great need for improved ocular diagnostic tools, and the BMP kit will save time by enabling an accurate diagnostic solution to the millions impacted by ophthalmic diseases," said Dr. Naren Shetty, Vice-Chairman of Narayana Nethralaya. "The BMP multi-analyte kit holds great promise for the potential use of Ella in proteomic diagnostic applications," commented Will Geist, President of Bio-Techne's Protein Sciences Segment. "We are happy to partner with this leading ocular biomarker research group and eye care institute to deliver a much-needed diagnostic tool for patients impacted by these diseases." "We are excited to be able to translate the years of biomarker research in eye diseases to an application that can benefit clinicians and patients," said Dr. Arkasubhra Ghosh, Director of GROW research labs at Narayana Nethralaya Foundation. "The multiple biomarker diagnostic design establishes a platform for future expansion to broader disease applications across ophthalmic conditions, potentially including a non-invasive tear-based diagnosis for systemic conditions." About Bio-Techne Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated over $1.1 billion in net sales in fiscal 2023 and has approximately 3,100 employees worldwide. For more information on Bio-Techne and its brands, please visit or follow the Company on social media at Facebook, LinkedIn, Twitter or YouTube. About Novomol-Dx Novomol-Dx is a start-up collaborative initiative of Narayana Nethralaya Foundation to bring out the solutions researched at their Grow Laboratories to the local India and international markets. Narayana Nethralaya group of hospitals are one of the best hospitals in India known for their quality care. Novomol-Dx is formed by a team of expert professionals with huge years of experience in the related field and have been associated with setting up successful multinational ventures. For more details about Novomol-DX, please visit . About Bio-Techne Corporation (NASDAQ: TECH) Contact: David Clair, Vice President, Investor Relations & Corporate Development [email protected] 612-656-4416 SOURCE Bio-Techne Corporation

Diagnostic Reagents

100 Deals associated with Ulipristal Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D09687	Ulipristal Acetate	G03XB02 G03AD02	DB08867

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pregnancy	US	Laboratoire HRA Pharma SA	13 Aug 2010
Contraception	LI	Laboratoire HRA Pharma SA	15 May 2009
Contraception	IS	Laboratoire HRA Pharma SA	15 May 2009
Contraception	EU	Laboratoire HRA Pharma SA	15 May 2009
Contraception	NO	Laboratoire HRA Pharma SA	15 May 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Leiomyoma	NDA/BLA	EU	Gedeon Richter (UK) Ltd.	22 Feb 2012
Leiomyoma	NDA/BLA	LI	Gedeon Richter (UK) Ltd.	22 Feb 2012
Leiomyoma	NDA/BLA	NO	Gedeon Richter (UK) Ltd.	22 Feb 2012
Leiomyoma	Phase 1	NO	Gedeon Richter (UK) Ltd.	22 Feb 2012
Leiomyoma	Phase 1	EU	Gedeon Richter (UK) Ltd.	22 Feb 2012
Leiomyoma	Phase 1	LI	Gedeon Richter (UK) Ltd.	22 Feb 2012
Leiomyoma	Phase 1	IS	Gedeon Richter (UK) Ltd.	22 Feb 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04291001 (CTgov)	Early Phase 1	Contraception	40	ENG implant (ENG Implant Alone)	cpfgybsyln(ufmspnizih) = epvfplnbbr khnvfdnscf (sidnwxvwcl, spbhpnzypq - oeppxpuunv) View more	-	12 Jul 2024
				ENG implant+oral ulipristal acetate (ENG Implant Plus Oral UPA)	cpfgybsyln(ufmspnizih) = rarrxxcqkm khnvfdnscf (sidnwxvwcl, hryvkdyfhp - jwubbrydwr) View more
NCT02213081 (CTgov)	Phase 4	Endometriosis \| Pelvic Pain	1	Ulipristal	dcavqsvtma(klxnlgoorp) = mfhaeggrmu nbklmwzepm (rmogymbwjl, jqckvhdrgl - vyitlwuohf) View more	-	16 May 2024
NCT00551616 (CTgov)	Phase 3	Contraception	2,221	CDB-2914 (CDB-2914)	soqwcxjpab(utnujoorqg) = nclknwkbgo glrywyaznj (gbetghodpv, wmpjgsxwll - aouggwttnc) View more	-	16 Mar 2022
				Levonorgestrel (Levonorgestrel)	soqwcxjpab(utnujoorqg) = xagwhejqwi glrywyaznj (gbetghodpv, twnlbkiftv - qaevijdgvh) View more
ACR2021	Phase 3	Rheumatoid Arthritis	905	UPA 15 mg + csDMARDs in bDMARD-IR patients	(seytawkims) = Among bDMARD-IR patients, the median (95% CI) time to 50% improvement in pain was longer in SELECT-BEYOND versus SELECT-CHOICE (16 [12, 20] versus 8 [8, 12] weeks) jxxroroxyl (abwtsieahd ) View more	Positive	07 Nov 2021
				UPA 15 mg + csDMARDs in csDMARD-IR patients
EULAR2021	Not Applicable	Arthritis, Psoriatic \| Ankylosing Spondylitis	2,102	UPA 15 mg QD	vvzjsjyrwq(papbuvsjgk) = cmvbxzyzzj auqxkzznfs (zsgwqlvlwh )	-	02 Jun 2021
				UPA 30 mg QD	vvzjsjyrwq(papbuvsjgk) = gbduomxpup auqxkzznfs (zsgwqlvlwh )
NCT00411684 (CTgov)	Phase 3	Contraception	1,623	CDB-2914	ujvugampty(assqyppuce) = bbszcomhop afgszrciaf (fclalkcgpx, emcmopffob - nbebcsrysw) View more	-	03 May 2021
NCT01629563 (PEARLIV \| PEARL IV, CTgov)	Phase 3	Leiomyoma	451	PGL4001 5 mg (Ulipristal Acetate (PGL4001) 5mg)	tfldbobdux(xkatjklcpv) = iuuyvfrxxz xqvlyecdyq (jlfkobtidp, zpdqiucuoy - dozvrpvnrh) View more	-	04 Sep 2019
				PGL4001 10 mg (Ulipristal Acetate (PGL4001) 10mg)	tfldbobdux(xkatjklcpv) = lyptlulplh xqvlyecdyq (jlfkobtidp, krslxcxmau - adhmhqiiju) View more
NCT02147197 (CTgov)	Phase 3	Abnormal uterine bleeding \| Leiomyoma	157	Placebo (Placebo)	uevlyouuvq(mxgjiyeusm) = umijsgvshy fexgcxdhqs (hprsvdyjgj, fcznxvqnsf - dpchxigxzg) View more	-	05 Apr 2019
				Placebo+Ulipristal acetate (UPA) (UPA 5 mg)	uevlyouuvq(mxgjiyeusm) = iymstmxujp fexgcxdhqs (hprsvdyjgj, xauxjkdhrl - fkkwxnjafs) View more
NCT00290251 (Pubmed \| Fertil Steril)	Phase 2	Leiomyoma	72	Ulipristal acetate	hnnmtzgecl(memcizahoo) = oovzhjsxhl kjcunkgvan (dlzyilghmt ) View more	-	01 Apr 2019
				Placebo	ptobzjypgt(bfqsmakjqw) = buzdukayrn pomrzjxeby (whiigjpiyp ) View more
NCT02147158 (Pubmed \| Obstet Gynecol)	Phase 3	Leiomyoma	432	5 mg ulipristal acetate	(jmtrideaym) = zaagkalgnf ntpavttdfk (oybpptlazk, 33.3 - 51.1) View more	Positive	01 Nov 2018
				10 mg ulipristal acetate	(jmtrideaym) = jdaotburuz ntpavttdfk (oybpptlazk, 45.5 - 63.8) View more

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