Endometriosis is the most common reproductive disease afflicting young women, often leading to debilitating chronic pelvic pain and impaired quality of life. Safe, effective, and convenient long-term treatments are lacking for adolescents and young adults. The levonorgestrel-containing IUD (LNG-IUD) represents an attractive long-term drug delivery system for the treatment of endometriosis during adolescence and young adulthood. However, while the LNG-IUD has an acceptable safety profile, it is not associated with a favorable bleeding profile and may not fully suppress endometriosis pain when used as monotherapy. Investigators hypothesize that the addition of NETA will improve bleeding patterns, maximize pain control, and improve continuation rates of the IUD when the two medications are used in combination. This proposed prospective trial provides the ideal context in which to investigate these clinical questions and advance research on the best treatments for endometriosis.

Start Date01 Jan 2026

Sponsor / Collaborator

The Children's Hospital Corp.

CTRI/2024/07/070268 / Not yet recruitingNot Applicable

A Cross-sEctional Analysis to assess Safety and utilization of norEthisterone Acetate controlled release tablet in management of abnormal uterine bleeding in real world clinical settings of India - CEASE-1

Start Date22 Jul 2024

Sponsor / Collaborator

Torrent Pharmaceuticals Ltd.

NCT05916469 / Not yet recruitingNot ApplicableIIT

Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

The goal of this multicenter prospective observational study and registry of U.S. adolescents and young adults with heritable bleeding disorders is to determine the bleeding outcomes, satisfaction, hemostatic parameter changes, and patient reported quality of life after 6 months of use of either of two commonly used hormonal treatments for menstrual suppression - levonorgestrel intrauterine device (LNG-IUD) and norethindrone acetate (NETA). Under this application we will compare the two treatments and compare outcomes after LNG-IUD treatment results to a control group without a bleeding disorder, with the goal of determining the benefits and expected outcomes of these treatment options for this population.

Start Date01 Jul 2024

Sponsor / Collaborator

Oregon Health & Science University

[+1]

100 Clinical Results associated with Norethindrone Acetate

100 Translational Medicine associated with Norethindrone Acetate

100 Patents (Medical) associated with Norethindrone Acetate

1,197

Literatures (Medical) associated with Norethindrone Acetate

01 Oct 2024·BMJ Open

Breast and endometrial safety of micronised progesterone versus norethisterone acetate in menopausal hormone therapy (PROBES): study protocol of a double-blind randomised controlled trial

Article

Author: Iliadis, Stavros I ; Lundell, Christina ; Schuppe-Koistinen, Ina ; Blomberg, Liselott ; Ujvari, Dorina ; Kopp-Kallner, Helena ; Stergiopoulos, Nikolaos ; Hirschberg, Angelica Linden ; Skalkidou, Alkistis

IntroductionData suggest that micronised progesterone (mP) in menopausal hormone therapy is safer for the breast than synthetic progestins, while protection of the endometrium appears to be less effective. However, comparative randomised trial data are lacking. The objective of the Progesterone Breast Endometrial Safety Study is to investigate breast and endometrial safety of mP versus norethisterone acetate (NETA) in continuous combination with oral oestrogen.Methods and analysisThis multicentre trial, conducted at three University Hospitals in Stockholm and Uppsala, Sweden, consists of two phases: part 1 focuses on breast safety and is designed as a double-blind, randomised controlled trial. 260 postmenopausal women will be randomised to 100 mg mP or 0.5 mg NETA per day in continuous combination with 1 mg oestradiol. The primary objective is to compare the treatments with respect to percentage change in mammographic breast density after 12-month treatment. Secondary outcomes are breast proliferation, endometrial histology and proliferation, bleeding pattern, gut and vaginal microbiome, hormone levels and coagulation and metabolic factors, mood, and health-related quality of life. Part 2 features an open, single-arm design to study endometrial safety of 1-year treatment with mP in continuous combination with oestradiol on endometrial pathology (hyperplasia and cancer). We will treat 260 additional women with 100 mg mP/1 mg oestradiol resulting in an endometrial safety population of 390 women. The total number of participants in part 1 and part 2 will be 520.Ethics and disseminationThe study protocol was approved by the Swedish Ethical Review Authority (2021-03033) on 29 June 2021 with amendment (2023-01480-02, protocol version 3.1) on 14 March 2023. Results of the study will be published in peer-reviewed journals and presented at scientific meetings.Trial registration numberNCT05586724.

01 Oct 2024·Fertility and Sterility

Impact of relugolix combination therapy on functioning and quality of life in women with endometriosis-associated pain

Article

Author: Abrao, Mauricio S ; Wilk, Krzysztof ; Zhong, Yi ; Becker, Christian M ; Reznichenko, Galyna ; Hunsche, Elke ; Perry, Julie ; Soulban, Graziella ; As-Sanie, Sawsan

OBJECTIVETo evaluate the effect of relugolix combination therapy (relugolix CT; 40 mg relugolix, 1 mg estradiol, and 0.5 mg norethisterone acetate) for up to 2 years in the SPIRIT long-term extension study on functioning and health-related quality of life (QoL), using the Endometriosis Health Profile (EHP)-30 questionnaire, and assess how changes in QoL domains correlated with improvements in dysmenorrhea as well as nonmenstrual pelvic pain (NMPP).DESIGNLong-term extension study of the SPIRIT phase 3 trials.SETTINGClinics and University Hospitals.PATIENT(S)Premenopausal women with moderate-to-severe endometriosis pain who previously completed the randomized SPIRIT trials were eligible to enroll in an 80-week long-term extension where all women received relugolix CT.INTERVENTION(S)Relugolix CT (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg).MAIN OUTCOME MEASURE(S)Least squares (LS) mean changes in the EHP-30 domain and total scores from baseline (pivotal) were analyzed using a mixed-effects model. Results up to 104 weeks are reported by a pivotal trial treatment group with a focus on the relugolix CT group (i.e., relugolix CT or placebo for 24 weeks, or delayed relugolix CT [relugolix 40 mg monotherapy for 12 weeks, followed by relugolix CT for 12 weeks]). In addition, the relationships between changes in dysmenorrhea and NMPP as well as changes in EHP-30 scores were assessed.RESULT(S)In the 277 women treated with relugolix CT, LS mean EHP-30 pain domain scores improved by 57.8% (LS mean change: -32.8; 95% CI: -35.5, -30.1), 66.4% (LS mean change: -37.7; 95% CI: -40.3, -35.0), and 72.2% (LS mean change: -41.3; 95% CI: -43.9, -38.7) at weeks 24, 52, and 104, respectively. The proportions of women with clinically meaningful improvement in the EHP-30 pain domain were 75.9%, 83.6%, and 88.6% at weeks 24, 52, and 104, respectively. Non-pain EHP-30 domain and total scores likewise improved. A positive correlation between changes in dysmenorrhea/NMPP and all EHP-30 domain scores was observed. Results were similar for the delayed relugolix CT and placebo → relugolix CT groups.CONCLUSION(S)Sustained reduction of endometriosis-associated pain with relugolix CT observed up to 104 weeks was accompanied by improvements in functioning and health-related QoL. These findings complement the results of the pivotal SPIRIT trials, which showed that relugolix combination therapy significantly reduced dysmenorrhea, NMPP, and dyspareunia vs. placebo in premenopausal women with endometriosis-associated pain.CLINICAL TRIAL REGISTRATION NUMBERRegistration/clinicaltrials.gov identifier: SPIRIT Extension Study (NCT03654274).

17 Sep 2024·Quintessence international (Berlin, Germany : 1985)

Effect of ethinyl estradiol/ norethisterone acetate with and without scaling on periodontal status and high-sensitivity C-reactive protein levels in women with polycystic ovarian syndrome having gingivitis: a randomized controlled trial.

Article

Author: Singhal, Savita Rani ; Verma, Richa ; Sangwan, Aditi ; Tewari, Shikha

OBJECTIVESCombined oral contraceptives are used for the management of hyperandrogenism and menstrual abnormalities in polycystic ovarian syndrome (PCOS). There is a dearth of literature addressing the effect of ethinyl estradiol/norethisterone acetate (EE/NETA) on gingival and systemic inflammation in these patients. This randomized trial aims to evaluate the effect of EE/NETA with and without scaling on periodontium and high sensitivity C-reactive protein (hsCRP) levels in women with PCOS having gingivitis.METHODSWomen having PCOS along with gingivitis were randomly divided into two groups: Test Group (TG, n=30) received EE/NETA + scaling with oral hygiene instructions (OHI) and Control Group 1 (CG1, n=30) received EE/NETA + OHI. Another Control Group (CG2, n=30) consisting of systemically healthy females having gingivitis and who were age and BMI matched with the test group participants received scaling along with OHI. Periodontal and anthropometric parameters were measured at baseline, 3 months and 6 months follow-up. Serum hsCRP levels were also estimated.RESULTSSerum hsCRP levels and periodontal parameters were significantly decreased in all the groups after 6 months (p≤0.05). The decrease in hsCRP levels was similar among the groups (p>0.05). Significantly more reduction in gingival inflammation was observed in TG compared to CG1 (p≤0.05).CONCLUSIONEE/NETA used alone and with scaling showed no detrimental effect on gingiva and could reduce systemic and gingival inflammation in women with PCOS having gingivitis.

News (Medical) associated with Norethindrone Acetate

05 Sep 2024

·pmlive.com

MHRA authorises first in new class of treatment for endometriosis symptoms

The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence for Gedeon Richter’s Ryeqo for adults with endometriosis symptoms, making it the first in a new class of treatments authorised in the UK for this patient population. Those eligible to receive the combination therapy, which consists of non-peptide gonadotrophin-releasing hormone receptor antagonist relugolix 40mg, estradiol 1mg and norethisterone acetate 0.5mg taken in a single once-daily tablet, will be of reproductive age and have a history of previous medical or surgical treatment for their endometriosis. Affecting approximately 176 million women worldwide, endometriosis is a chronic condition that occurs when tissue similar to the lining of the uterus grows outside of the uterus. Patients can experience a range of symptoms, including dysmenorrhoea (painful cramping, usually in the lower abdomen), heavy bleeding and pelvic pain, and the disease can be associated with sub-fertility or infertility. The MHRA’s decision was supported by positive results from the late-stage SPIRIT programme, in which significantly more patients achieved pain reduction with Ryeqo versus placebo at 24 weeks. In the SPIRIT 1 study, 75% of patients responded to Ryeqo for their dysmenorrhoea compared to 27% in the placebo arm. The same result was seen in the SPIRIT 2 trial, with 75% of dysmenorrhoea responders in the Ryeqo cohort compared to 30% for placebo. Additionally, 59% and 66% of patients responded to Ryeqo for their non-menstrual pelvic pain (NMPP) in SPIRIT 1 and 2, respectively, compared to 40% and 43% of those receiving placebo. Dysmenorrhoea and NMPP reduction was also sustained over two years with Ryeqo treatment, according to results from a long-term extension study. David Jordan, medical director UK and Ireland, Gedeon Richter, said: “The MHRA’s decision to licence relugolix combination therapy in endometriosis is fantastic news and we are delighted the need for more treatment options has been recognised. “We have been working hard to bring a new way of treating the condition to clinicians and women suffering with painful symptoms and we believe this authorisation will be a welcome step for redefining care.” Jordan added that the company is now engaging with the relevant health authorities throughout the UK “with a view to securing NHS reimbursement as soon as possible.”

Clinical ResultDrug Approval

05 Mar 2024

·firstwordpharma.com

Sumitomo’s US arm trims more jobs amid restructuring blitz

After axing around 500 positions at its US unit in July last year, Sumitomo Pharma announced another round of layoffs – this time slashing approximately 400 jobs, primarily in sales and marketing, as it intensifies efforts to restructure the subsidiary.The company cited the “current severe business environment” and the failure to achieve projected sales targets for three of its key products - Orgovyx (relugolix), Myfembree (relugolix/estradiol/norethisterone acetate), and Gemtesa (vibegron). Sumitomo recently revised down estimates for the drugs, with North American sales of Orgovyx in the current fiscal year seen reaching $290 million, down from an earlier prediction of $396 million.Meanwhile, annual revenue from Gemtesa in North America is now seen at $260 million, cut from previous guidance of $362 million, with Myfembree set to bring in $70 million, slashed from a prior forecast of $192 million. Jefferies analysts called the cuts to the outlook “bigger-than-expected,” noting that it is “increasingly unlikely” that the company will meet the targets of its “ambitious-looking medium term plan.”Sumitomo has also seen a significant revenue dip due to US patent expiry for the schizophrenia therapy Latuda (lurasidone). Sales of the product in North American plunged 97% in the third quarter of the current fiscal year to $5 million.Assets that the drugmaker hoped would replace lost revenue from Latuda have also stumbled in development. Last year, a pair of Phase III studies investigating the Otsuka-partnered schizophrenia candidate ulotaront failed to meet their primary endpoints. Sumitomo said recently that the development strategy for the drug in this indication continues to be discussed with Otsuka.

Phase 3NDAFinancial StatementBiosimilar

19 Oct 2023

·www.prnewswire.com

Sumitomo Pharma and Pfizer in Canada Receive Health Canada Approval for MYFEMBREE®

MISSISSAUGA, ON and KIRKLAND, QC, Oct. 19, 2023 /PRNewswire/ -- Sumitomo Pharma Canada, Inc. and Pfizer Canada today announced that Health Canada has granted a Notice of Compliance (NOC) for MYFEMBREE (Relugolix, estradiol and norethindrone acetate tablets) for the management of moderate to severe pain associated with endometriosis in pre-menopausal women on October 17, 2023. On September 22, 2023, Health Canada also approved MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. This combination therapy oral treatment is taken once daily and provides a new option for women to manage their symptoms related to endometriosis and uterine fibroids. "Health Canada's approval of MYFEMBREE across the uterine fibroid and endometriosis indications marks a significant milestone in our commitment to women's health," said Lisa Mullett, General Manager, Sumitomo Pharma Canada, Inc. "These are multi-faceted and complex chronic conditions, and we are proud to make new treatment options available to women in Canada." "MYFEMBREE's approval is a testament to the shared commitment between our two companies to support women's health," added Andréa Mueller, Primary Care Portfolio Lead at Pfizer Canada. "We are proud to help women manage their health at all stages of their lives." This approval is based on several comprehensive Phase 3 studies, including the LIBERTY 1 and LIBERTY 2 trials for uterine fibroids and the SPIRIT 1 and SPIRIT 2 trials for endometriosis. "Uterine fibroids and endometriosis are very common conditions affecting millions of Canadians. Endometriosis, in particular, can be a very challenging and complex condition to treat, often resulting in years of delay to diagnosis, said Dr. Sony Sukhbir Singh, Professor and Chair of the Department of Obstetrics and Gynecology, at the University of Ottawa. "These conditions can cause debilitating symptoms such as pain and bleeding, impacting daily life and overall well-being for many girls, women and gender diverse individuals." Following this approval Pfizer Canada will lead commercialization efforts of MYFEMBREE in the uterine fibroid and endometriosis indications. In partnership with Sumitomo Pharma in Canada, Pfizer Canada is currently assessing the timeline of availability for MYFEMBREE and are committed to bringing supply of this medicine to Canadians as quickly as possible. About Uterine Fibroids Uterine fibroids are the most common benign tumors in women of reproductive age.1 Uterine fibroids may be underdiagnosed due to several factors. Roughly 50 to 80% of women may have asymptomatic fibroids, meaning they don't experience noticeable symptoms. Additionally, some women with fibroid-related symptoms, such as heavy menstrual bleeding and pain, might not seek medical attention because they consider these issues to be a normal part of their menstrual cycles. Furthermore, healthcare providers may sometimes dismiss these symptoms as normal, contributing to the underestimation of uterine fibroid prevalence in Canadian women. 2,3,4,5 About Endometriosis Endometriosis is a chronic disease characterized by growth of endometrial-like tissue outside the uterus.6 This growth of endometriotic tissue relies on estrogen, a hormone crucial for regulating the female reproductive system.7 Endometriosis mainly affects women of reproductive age, occurring between their first menstrual period and menopause, when estrogen levels decline.8 In Canada, 7.0% of women aged 18-48 have endometriosis, with an average diagnosis age of 27.9. Most Canadian women experience symptoms before diagnosis with an average delay of 5.4 years in diagnosis.9 Symptoms include menstrual pain, pelvic pain, and pain during sex, with 60% reporting moderate to severe pain. 6,9,10 Endometriosis can impact fertility, quality of life, and work productivity.11 About MYFEMBREE® MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) has received a dual indication approval, making it the first Health Canada-approved oral treatment to manage uterine fibroids and endometriosis. MYFEMBREE was approved by the U.S. Food and Drug Administration for the treatment of heavy menstrual bleeding associated with uterine fibroids in May 2021 and for the management of moderate to severe pain associated with endometriosis in August 2022. About Sumitomo Pharma Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information, please visit or follow us on LinkedIn. About Pfizer Canada Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified healthcare portfolio includes some of the world's best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube. 1 BMC Public Health, Global, regional, and national time trends in incidence, prevalence, years lived with disability for uterine fibroids, 1990–2019: an age-period-cohort analysis for the global burden of disease 2019 study, , Accessed August 22, 2023 2 Laberge PY, Vilos GA, Vilos AG, Janiszewski PM. Burden of symptomatic uterine fibroids in Canadian women: a cohort study. Curr Med Res Opin. 2016;32(1):165-75. doi:10.1185/03007995.2015.1107534 3 Bukulmez O, Doody KJ. Clinical features of myomas. Obstet Gynecol Clin North Am. Mar 2006;33(1):69-84. doi:10.1016/j.ogc.2005.12.002 4 Stovall DW. Clinical symptomatology of uterine leiomyomas. Clin Obstet Gynecol. Jun 2001;44(2):364-71. doi:10.1097/00003081-200106000-00022 5 Zimmermann A, Bernuit D, Gerlinger C, Schaefers M, Geppert K. Prevalence, symptoms and management of uterine fibroids: an international internet-based survey of 21,746 women. BMC Women's Health. Mar 26 2012;12:6. 6 Zondervan, K.T., et al., Endometriosis. Nat Rev Dis Primers, 2018. 4(1): p. 9. 7 Ahn, S.H., et al., Pathophysiology and immune dysfunction in endometriosis. BioMed research international, 2015. 2015. 8 Stratton, P. and K.J. Berkley, Chronic pelvic pain and endometriosis: translational evidence of the relationship and implications. Hum Reprod Update, 2011. 17(3): p. 327-46. 9 Singh, S., et al., Prevalence, symptomatic burden, and diagnosis of endometriosis in Canada: cross-sectional survey of 30 000 women. Journal of Obstetrics and Gynaecology Canada, 2020. 42(7): p. 829-838. 10 Becker, K., et al., Real world data on symptomology and diagnostic approaches of 27,840 women living with endometriosis. Scientific Reports, 2021. 11(1): p. 1-9. 11 Macer, M.L. and H.S. Taylor, Endometriosis and infertility: a review of the pathogenesis and treatment of endometriosis-associated infertility. Obstetrics and Gynecology Clinics, 2012. 39(4): p. 535-549. SOURCE Sumitomo Pharma America

Drug ApprovalPhase 3

100 Deals associated with Norethindrone Acetate

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KEGG	Wiki	ATC	Drug Bank
D00953	Norethindrone Acetate	G03AC01 G03DC02	-

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Indication	Highest Phase	Country/Location	Organization	Date
Contraception Behavior	Phase 1	US	Actavis, Inc.	01 May 2010

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05294341 (CTgov)	Phase 4	Contraception	6	Norethindrone Acetate (5mg Norethindrone Acetate)	axhfnxptmv(jzxszjslwd) = bqyeudiodi lowhuwkwsc (ppobkkrzqa, auzvvmwpdm - fvptlafyxb) View more	-	16 Jul 2024
				Norethindrone (0.35mg Norethindrone)	axhfnxptmv(jzxszjslwd) = optxtecnwi lowhuwkwsc (ppobkkrzqa, bvjgdhjedg - eyvnyrotjc) View more
NCT03970330 (CTgov)	Phase 3	Endometriosis \| Chronic pelvic pain syndrome	9	Norethindrone Acetate+Naltrexone (Low-Dose Naltrexone)	cvidlwwlox(pwemggbtde) = xphlvsqzjv mqizxvbucv (jmkxkiatge, uqhwqcevea - aiudxptjwz) View more	-	03 Nov 2022
				Placebo+Norethindrone Acetate (Placebo)	cvidlwwlox(pwemggbtde) = xffgnljzfr mqizxvbucv (jmkxkiatge, mzxqkuoxpi - pwpkxvssqg) View more
NCT01667978 (NET, CTgov)	Not Applicable	Pregnancy \| Acquired Immunodeficiency Syndrome	35	Norethindrone acetate	xiqulmuzel(swrtqjhple) = ggvxqwzakz gbkoahgvla (arnknjislv, fsapqfztdb - wfrlzgybkh) View more	-	20 Aug 2015
NCT00474851 (CTgov)	Phase 2	Endometriosis	53	estrogens+Norethindrone acetate (Intervention Group)	(wldpiteeml) = xmmopgmvba naxknsskil (hjpjkdicew, hfprtkxffo - vyhbadebff) View more	-	30 Mar 2015
				Placebo (Placebo Group)	(wldpiteeml) = gpaebfbatz naxknsskil (hjpjkdicew, urthfrkdig - kcsreocxpj) View more

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