Norethindrone
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Ryeqo | — | 2021-07-16 | europa.eu ↗ |
| Approved | US (FDA) | ORTHO-NOVUM 1/50 21 | — | 1962-05-21 | fda.gov ↗ |
Trials 86 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT07568509 | May 2026 → Apr 2027 expected | hypopituitarism, neurohypophyseal diabetes insipidus | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 0 | NCT03905941 | Aug 2021 → Nov 2024 | polycystic ovary syndrome | University of Virginia | Withdrawn | No outcome recorded Stop: Business |
| Phase 0 | NCT04423068 | Dec 2020 → Apr 2022 | pregnancy disorder | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
| Phase 0 | NCT02036879 | Feb 2014 → Aug 2018 | cystic fibrosis | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 127 trials · 2 met primary | ||||||
| Phase 1 | NCT07792408 | Sep 2026 → Mar 2027 expected | autosomal dominant polycystic kidney disease | Vertex Pharmaceuticals Incorporated | Recruiting | No outcome recorded |
| Phase 1 | NCT07074327 | Jul 2025 → Feb 2026 | autosomal dominant polycystic kidney disease | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT05579574 | Oct 2022 → Jun 2023 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT07215806 | Aug → Nov 2022 | — | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT04934696 | Aug 2021 → Jan 2022 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04714554 | Jan → Mar 2021 | — | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 1 | NCT04016753 | Aug 2019 → Feb 2020 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04709094 | Jul → Oct 2019 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03856970 | Mar → Jun 2019 | — | Ironwood Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03353857 | Nov 2017 → Jul 2018 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT03262740 | Sep → Dec 2017 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02705963 | Oct 2016 → Aug 2019 | cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04978688 | Jun → Sep 2016 | — | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 1 | NCT02832180 | May → Oct 2016 | arthritic joint disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02292732 | Feb 2016 → May 2017 | cancer | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT02652650 | Dec 2015 → Jun 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01953809 | Aug 2014 → Mar 2015 | bacterial infectious disease | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT02103569 | Apr → Jul 2014 | hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01597986 | Apr → Jun 2012 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01486004 | Nov 2011 → Jan 2012 | chronic hepatitis C virus infection | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT01077505 | Mar → Nov 2010 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00821496 | Jan → Mar 2009 | — | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT01344369 | Aug → Sep 2008 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT01596010 | Oct → Nov 2007 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01040845 | Aug 2007 → Jan 2008 | — | Mutual Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01157182 | Feb → Apr 2007 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT01477632 | Mar → Jun 2005 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT04948489 | Jan 2026 → Sep 2028 | endometriosis | Boston Children's Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06279195 | Jun 2024 → Nov 2025 | pelvis syndrome | Endeavor Health | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT01817530 | Apr 2013 → Jun 2015 | leiomyoma, uterine disorder | AbbVie | Completed | Met primary |
| Phase 2 | NCT00919919 | Jun 2009 → Sep 2010 | endometrial cancer | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT00338052 | Jun 2006 → May 2007 | — | Warner Chilcott | Completed | No outcome recorded |
| Phase 329 trials · 7 met primary · 1 missed | ||||||
| Phase 3 | NCT07100782 | Dec 2025 → Aug 2028 expected | endometriosis, pelvis syndrome | University of Michigan | Recruiting | No outcome recorded |
| Phase 3 | NCT05862272 | Aug 2023 → Jul 2029 expected | endometriosis, leiomyoma | Sumitomo Pharma Switzerland GmbH | Recruiting | No outcome recorded |
| Phase 3 | NCT05620355 | Dec 2022 → May 2024 | leiomyoma | Bio Genuine (Shanghai) Biotech Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04756037 | Mar 2021 → Feb 2025 | — | Sumitomo Pharma Switzerland GmbH | Completed | No outcome recorded |
| Phase 3 | NCT04290013 | Apr → Oct 2020 | uterine disorder | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT03986944 | May 2019 → Jan 2021 | endometriosis | Kissei Pharmaceutical Co., Ltd. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03343067 | Dec 2017 → Oct 2018 | endometriosis | AbbVie | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03204331 | Nov 2017 → Apr 2020 | endometriosis | Myovant Sciences GmbH | Completed | Met primary |
| Phase 3 | NCT03271489 | Sep 2017 → Jun 2024 | leiomyoma | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03049735 | Apr 2017 → Apr 2019 | leiomyoma | Myovant Sciences GmbH | Completed | Met primary |
| Phase 3 | NCT03070899 | Apr 2017 → Apr 2020 | leiomyoma | ObsEva SA | Completed | Met primary |
| Phase 3 | NCT02691494 | Feb 2016 → Feb 2018 | leiomyoma | AbbVie | Completed | Met primary |
| Phase 3 | NCT03106454 | Aug 2014 → Jan 2024 | anovulation | University of Southern California | Completed | No outcome recorded |
| Phase 3 | NCT01252069 | Jan 2011 → Aug 2013 | leiomyoma | PregLem SA | Completed | No outcome recorded |
| Phase 3 | NCT01246791 | Nov 2010 → May 2011 | — | Nobelpharma | Completed | No outcome recorded |
| Phase 3 | NCT01156857 | Jul 2010 → Nov 2011 | leiomyoma | PregLem SA | Completed | No outcome recorded |
| Phase 3 | NCT01129102 | May 2010 → Apr 2011 | dysmenorrhea | Nobelpharma | Completed | Met primary |
| Phase 3 | NCT01140217 | May 2010 → Mar 2012 | — | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01044498 | Dec 2009 → Feb 2012 | rheumatoid arthritis | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00902746 | May 2009 → Feb 2012 | dysmenorrhea | Nobelpharma | Completed | No outcome recorded |
| Phase 3 | NCT00746096 | Sep 2008 → Sep 2009 | primary dysmenorrhea | Nobelpharma | Completed | Met primary |
| Phase 3 | NCT00391807 | Nov 2006 → Aug 2008 | — | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00212277 | Feb 2005 → Sep 2006 | dysmenorrhea | Nobelpharma | Completed | No outcome recorded |
| Phase 3 | NCT00212342 | Dec 2004 → Jan 2006 | dysmenorrhea | Nobelpharma | Completed | No outcome recorded |
| Phase 3 | NCT00229996 | Jul 2004 → ? | endometriosis, pelvis syndrome | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 3 | NCT00184795 | May 2004 → May 2005 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00932321 | Jan → Nov 2004 | — | Warner Chilcott | Completed | No outcome recorded |
| Phase 3 | NCT00003771 | Sep 1997 → Feb 2004 | breast cancer | Regional Oncologic Center | Completed | Missed primary |
| Phase 3 | NCT00000420 | Jun 1997 → Aug 2003 | systemic lupus erythematosus | NYU Langone Health | Completed | Met primary |
| Phase 411 trials · 3 met primary | ||||||
| Phase 4 | NCT05538689 | Nov 2022 → Oct 2024 | leiomyoma, menstrual disorder | University of Chicago | Withdrawn | No outcome recorded |
| Phase 4 | NCT05293574 | Oct 2022 → Oct 2023 | ovarian cyst | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT04965116 | Oct 2021 → Nov 2022 | — | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT04047875 | Sep 2020 → May 2023 | — | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT02264743 | Nov 2013 → Nov 2014 | venous thromboembolism | Royal Brompton & Harefield NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 4 | NCT03594604 | Jun → Dec 2007 | menstrual disorder | Wayne State University | Completed | Met primary |
| Phase 4 | NCT00431093 | Nov 2002 → Mar 2005 | — | Organon and Co | Completed | Met primary |
| Phase 4 | NCT00732693 | Feb 2002 → Nov 2006 | primary ovarian failure | University of Edinburgh | Completed | Mixed |
| Phase 4 | NCT01705249 | Aug 2001 → Jun 2003 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT03921736 | Jan 2000 → Mar 2001 | essential hypertension | Anna Posadzy-Małaczyńska | Completed | No outcome recorded |
| Phase 4 | NCT00252408 | Oct 1990 → Dec 2003 | osteoporosis | University of Aarhus | Completed | Met primary |
| Phase not applicable10 trials · 1 met primary | ||||||
| — | NCT07173127 | Sep 2025 → Dec 2026 expected | uterine benign neoplasm | University Hospital, Geneva | Recruiting | No outcome recorded |
| — | NCT06358014 | May 2023 → Dec 2024 | depressive disorder | Xiao Wang | Unknown | No outcome recorded |
| — | NCT02353247 | Aug 2015 → Jun 2017 | — | Norton Healthcare | Completed | No outcome recorded |
| — | NCT01667978 | Jun 2012 → Sep 2013 | AIDS, pregnancy disorder | University of Southern California | Completed | Met primary |
| — | NCT00999479 | Oct 2009 → Oct 2011 | ovarian endometriosis | University of Oklahoma | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00580424 | Dec 2007 → Jul 2009 | blood coagulation disease | University of Vermont | Terminated | No outcome recorded |
| — | NCT00350480 | Apr 2003 → Jun 2005 | menstrual disorder, uterine disorder | Kaiser Permanente | Completed | No outcome recorded |
| — | NCT00006133 | Jun 2000 → ? | systemic lupus erythematosus | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| — | NCT00825617 | Oct 1996 → Oct 1999 | Turner syndrome | University of Aarhus | Completed | No outcome recorded |
| — | NCT00877097 | Jul 1996 → Dec 2002 | osteoporosis | Kuopio University Hospital | Completed | No outcome recorded |
| Comparator or background therapy34 trials | ||||||
| Phase 1 | NCT02182791 Comparator | Apr 1998 → Apr 1999 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02542410 Comparator | May 2016 → Sep 2018 | endometriosis | Boston Children's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01631981 Background | Jun 2012 → Oct 2013 | endometriosis | PregLem SA | Completed | No outcome recorded |
| Phase 2 | NCT01466114 Background | Oct 2011 → Dec 2021 | primary progressive multiple sclerosis, relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | University of California, Los Angeles | Unknown | No outcome recorded |
| Phase 2 | NCT00453960 Comparator | Jan 2007 → Nov 2008 | endometrial hyperplasia without atypia | University of Messina | Completed | No outcome recorded |
| Phase 2/3 | NCT01160315 Background | Jul 2002 → Jun 2010 | lymphoma, primary ovarian failure | Erasme University Hospital | Completed | Missed primary |
| Phase 3 | NCT06439524 Comparator | Aug 2024 → Jun 2028 expected | endometriosis | Main Line Health | Recruiting | No outcome recorded |
| Phase 3 | NCT05894135 Background | Jul 2023 → Jun 2024 | endometriosis of pelvic peritoneum | Bio Genuine (Shanghai) Biotech Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT05586724 Comparator | Mar 2022 → Sep 2026 overdue | — | Angelica Lindén Hirschberg | Recruiting | No outcome recorded |
| Phase 3 | NCT04527003 Comparator | Dec 2020 → May 2024 | endometriosis | Milton S. Hershey Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03970330 Background | Jan 2020 → Jun 2021 | endometriosis | Milton S. Hershey Medical Center | Terminated | Missed primary Stop: Business |
| Phase 3 | NCT03992846 Background | Jun 2019 → Oct 2021 | endometriosis | Kissei Pharmaceutical Co., Ltd. | Completed | Mixed |
| Phase 3 | NCT03412890 Background | Oct 2017 → Jan 2020 | leiomyoma | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT02925494 Background | Sep 2016 → May 2018 | leiomyoma | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01656434 Comparator | Nov 2012 → Feb 2014 | — | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01253824 Comparator | Jan → Jul 2011 | — | Nobelpharma | Completed | No outcome recorded |
| Phase 3 | NCT00522873 Comparator | Aug 2007 → Aug 2009 | — | Bayer | Completed | Met primary |
| Phase 3 | NCT00458458 Comparator | Aug 2004 → Dec 2012 | dysmenorrhea, endometriosis | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Unknown | No outcome recorded |
| Phase 3 | NCT00413764 Comparator | Mar 2004 → Nov 2005 | sexual disorder | Organon and Co | Completed | Missed primary |
| Phase 4 | NCT07799246 Comparator | Oct 2026 → Apr 2029 expected | endometriosis | Colorado State University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07293728 Comparator | Jul → Dec 2026 expected | preeclampsia | Oregon Health and Science University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05294341 Comparator | Jul 2022 → May 2023 | — | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT04676061 Comparator | Feb 2021 → Jul 2022 | uterine disorder | Baylor Research Institute | Terminated | No outcome recorded |
| Phase 4 | NCT02693002 Comparator | Feb → Nov 2016 | — | Gretchen Wells | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02969590 Comparator | Mar 2015 → Aug 2017 | infertility disorder | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 4 | NCT02210702 Background | Jul 2014 → Jan 2015 | postpartum depression | The Jones Institute | Unknown | No outcome recorded |
| Phase 4 | NCT01391052 Comparator | Jan 2011 → Jan 2013 | menstrual disorder | Scott and White Hospital & Clinic | Unknown | No outcome recorded |
| — | NCT05050357 Comparator | Dec 2021 → Dec 2022 | pelvic congestion syndrome | Assiut University | Completed | No outcome recorded |
| — | NCT05476172 Comparator | Apr 2021 → May 2023 | endometriosis | Uludag University | Completed | No outcome recorded |
| — | NCT01499602 Comparator | May 2009 → Nov 2011 | endometrial hyperplasia without atypia | Mansoura University | Completed | No outcome recorded |
| — | NCT01266759 Comparator | Jul 2008 → Sep 2010 | menstrual disorder | Mansoura University | Completed | No outcome recorded |
| — | NCT00972439 Comparator | Aug 2007 → Nov 2008 | — | University of Southern California | Completed | No outcome recorded |
| — | NCT01465022 Comparator | Jan 2005 → Jun 2008 | — | University of New Mexico | Completed | No outcome recorded |
| — | NCT00600106 Comparator | Dec 1999 → May 2003 | myocardial ischemia | Cedars-Sinai Medical Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2023-11-02 | Gedeon Richter Ltd. | Regulatory EC approves RYEQO® for the Symptomatic Treatment of Endometriosis gedeonrichter.com ↗
the European Commission (‘EC’) has granted approval of a Type II Variation application for RYEQO® |
| 2023-09-15 | Gedeon Richter Ltd. | Regulatory Positive CHMP Opinion for RYEQO® for Treatment of Endometriosis gedeonrichter.com ↗
today announce that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has adopted a positive opinion |
| 2022-10-25 | Gedeon Richter Ltd. | Regulatory Submission for Type II Variation Application for RYEQO® for the Treatment of Endometriosis gedeonrichter.com ↗ |
| 2022-08-05 | Pfizer | Regulatory Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE®, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis pfizer.com ↗
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is a once-daily oral treatment approved by the U.S. Food and Drug Administration for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months. |
| 2022-06-17 | Pfizer | Results Myovant Sciences and Pfizer Announce Publication in The Lancet of Phase 3 SPIRIT 1 and SPIRIT 2 Studies of Once-Daily Relugolix Combination Therapy in Women With Endometriosis-Associated Pain pfizer.com ↗
As previously reported, both studies achieved their co-primary endpoints by demonstrating clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain in women with endometriosis. |
| 2022-06-02 | Pfizer | Regulatory Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE® pfizer.com ↗ |
| 2022-05-06 | Pfizer | Regulatory Myovant Sciences and Pfizer Provide Update on Supplemental New Drug Application (sNDA) for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis pfizer.com ↗ |
| 2022-04-12 | Pfizer | Regulatory Myovant Sciences and Pfizer Provide Update on Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated with Endometriosis pfizer.com ↗
The FDA noted that the letter does not reflect a final decision on the pending sNDA and that the application is still under review. |
| 2021-09-09 | Pfizer | Regulatory Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis pfizer.com ↗ |
| 2021-07-20 | Gedeon Richter Ltd. | Regulatory European Commission approves the commercialisation of RYEQO® gedeonrichter.com ↗
Gedeon Richter Plc. announces that the European Commission has granted approval for the marketing authorisation of RYEQO® a novel oral treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. |
| 2021-05-26 | Pfizer | Regulatory Myovant Sciences and Pfizer Receive FDA Approval for MYFEMBREE®, the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids pfizer.com ↗
The FDA approval of MYFEMBREE represents a significant milestone in expanding treatment options for uterine fibroids, a chronic and debilitating disease for many women in the U.S. |
| 2021-03-24 | Pfizer | Results Myovant Sciences and Pfizer Announce Positive Data from Phase 3 LIBERTY Randomized Withdrawal Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids pfizer.com ↗
78.4% of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment at Week 52 (p < 0.0001) |
| 2021-02-17 | Pfizer | Results Myovant Sciences and Pfizer Announce Publication in the New England Journal of Medicine of Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids pfizer.com ↗
In the LIBERTY studies, relugolix combination therapy improved the most bothersome symptoms of uterine fibroids and had a well-tolerated safety profile including maintenance of bone mineral density comparable to placebo. |
| 2021-01-26 | Pfizer | Results Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination Therapy in Women with Endometriosis pfizer.com ↗
84.8% and 73.3% of women reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain at one year |
| 2020-05-29 | AbbVie | Regulatory FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women abbvie.com ↗
announced that the U.S. Food and Drug Administration (FDA) approved ORIAHNN™ (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), with a treatment duration of up to 24 months. |
| 2018-05-29 | AbbVie | Regulatory Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules abbvie.com ↗
Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. |
| 2018-02-21 | AbbVie | Results AbbVie Announces Positive Topline Results from Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids abbvie.com ↗
The study also met all ranked secondary endpoints (p<0.001) at month six. |
All press releases naming this drug 18 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 124 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | norethindrone | “BACKGROUND: This study was conducted to compare breast epithelial-cell proliferation and estrogen and progesterone receptor levels in women taking one of two oral...” PMID 22325110 ↗ Feb 201241“An Open-Label, Single-Sequence, Crossover Study to Investigate the Interaction of Multiple Doses of BMS-986322 at Steady State and Multiple Doses of a Combined Oral Hormonal...” NCT05579574 ↗ “The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE,...” NCT07074327 ↗ “randomly assigned to receive either oral contraceptives (triphasic ethinyl estradiol at a dose of 35 microg plus norethindrone at a dose of 0.5 to 1 mg for 12 cycles of 28 days...” PMID 16354891 ↗ Dec 2005 “A Pharmacokinetics, Pharmacodynamics, and Safety Study of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK1322322 in Healthy...” NCT01953809 ↗ “A Phase 1 Study to Characterize the Effects of BMS-986166 on the Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone in Healthy Female Participants” NCT04934696 ↗ “An Open-label Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK716155” NCT01077505 ↗ “Ethinylestradiol (35 µg) and norethindrone (1.0 mg) are the components of Ovysmen, which is a widely used oral contraceptive (OC).” NCT01486004 ↗ “an oral contraceptive (OC) containing norethindrone (NE) and ethinyl estradiol (EE) (ORTHO-NOVUM® tablets: 1 mg NE + 0.035 mg EE)” NCT02292732 ↗ “a monophasic combination OC containing 1 mg norethindrone and 35 mug of ethinyl estradiol, each administered three times per day” PMID 17012455 ↗ Oct 2006 “subjects were randomized to receive either 1 mg norethindrone/10 microg ethinyl estradiol or placebo for 12 weeks.” PMID 20569710 ↗ Jun 2010 |
| Known as | NET | “BACKGROUND: This study was conducted to compare breast epithelial-cell proliferation and estrogen and progesterone receptor levels in women taking one of two oral...” PMID 22325110 ↗ Feb 20125“The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE,...” NCT07074327 ↗ “Combined Oral Contraceptive (OC) Containing Ethinyl Estradiol (EE) and Norethindrone Acetate (NET) in Healthy Female Subjects” NCT02832180 ↗ “Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET])” NCT05579574 ↗ “ethinyl estradiol (EE)/norethindrone (NET)” NCT02182791 ↗ “0.5 mg of Norethisterone (NET)” NCT07215806 ↗ |
| Known as | NETA | “OBJECTIVES: To investigate the long-term endometrial safety and bleeding pattern of the 0.25 mg drospirenone/0.5 mg 17β-estradiol (DRSP/E2) dose combination compared with 0.5...” PMID 23531117 ↗ May 201319“This is a single-arm, open-label, phase 3 study to assess the contraceptive efficacy of relugolix combination therapy (relugolix 40 milligrams [mg], estradiol [E2] 1 mg, and...” NCT04756037 ↗ “OBJECTIVE: To evaluate the effect of two ultra-low-dose hormone treatments containing estradiol (E2) 0.5 mg and norethisterone acetate (NETA) 0.1 or 0.25 mg on the endometrium...” PMID 18202966 ↗ Feb 2008 “They received daily estradiol hemihydrate (E2) 2mg + norethisterone acetate (NETA) 1mg (Kliogest®, Novo Nordisk, Denmark) and were randomized to get additional Boneplac” NCT00877097 ↗ “addition of estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg to relugolix 40 mg (relugolix combination therapy)” PMID 37365436 ↗ Jun 2023 “A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and norethindrone acetate (NETA) 0.5 mg.” NCT05862272 ↗ “Activelleâ, estradiol (E2) 1 mg and norethisterone acetate (NETA) 0.5 mg per tablet, was supplied as uncoded tablets.” NCT00431093 ↗ “1.0 mg estradiol; 0.5 mg norethindrone acetate, also known as norethisterone acetate [NETA]” PMID 38648863 ↗ Jun 2024 “norethindrone acetate (NETA), for the treatment of endometriosis-associated pain” PMID 34934987 ↗ Jul 2021 “norethisterone acetate (NETA) in continuous combination with oral oestrogen” PMID 39448218 ↗ Oct 2024 “estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg” NCT05894135 ↗ |
| Known as | norethindrone acetate | “OBJECTIVE: To assess the effect of once-daily relugolix combination therapy (relugolix-CT: relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) compared with...” PMID 35675604 ↗ May 202242“a monophasic oral contraceptive's active components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single oral dose alone and in combination with IW-3718...” NCT03856970 ↗ “This is a single-arm, open-label, phase 3 study to assess the contraceptive efficacy of relugolix combination therapy (relugolix 40 milligrams [mg], estradiol [E2] 1 mg, and...” NCT04756037 ↗ “Study medication will be provided by Sumitomo in pill bottles containing an 84-day supply of relugolix 40mg, estradiol 1mg, norethindrone acetate 0.5mg (Relugolix Combination therapy).” NCT07100782 ↗ “Oral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg will be used in this study.” NCT03905941 ↗ “Combined Oral Contraceptive (OC) Containing Ethinyl Estradiol (EE) and Norethindrone Acetate (NET) in Healthy Female Subjects” NCT02832180 ↗ “addition of estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg to relugolix 40 mg (relugolix combination therapy)” PMID 37365436 ↗ Jun 2023 “A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and norethindrone acetate (NETA) 0.5 mg.” NCT05862272 ↗ “Each tablet of Myfembree contains Relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5 mg.” NCT05538689 ↗ “1.0 mg estradiol; 0.5 mg norethindrone acetate, also known as norethisterone acetate [NETA]” PMID 38648863 ↗ Jun 2024 “Estradiol 1 mg / Norethindrone Acetate 0.5 mg for oral administration once daily.” NCT05620355 ↗ |
| Known as | norethisterone | “First line HRT was oral sequential oestradiol/norethisterone in women with intact uterus and oral continuous oestradiol in hysterectomised women.” NCT00252408 ↗13“NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition” NCT01246791 ↗ “Transdermal patches releasing 17β-estradiol (0.05 mg/24 hours) and norethisterone (0.25 mg/24 hours) for 12 months” NCT03921736 ↗ “Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.” NCT00902746 ↗ “NPC-01( 1mg Norethisterone and 0.02mg Ethinyl Estradiol)” NCT01253824 ↗ “ethinyl estradiol 0.035mg and norethisterone 1mg” NCT00746096 ↗ “Norethisterone 1mg, Ethinyl estradiol 0.02mg” NCT01129102 ↗ |
| Known as | norethisterone acetate | “OBJECTIVES: To investigate the long-term endometrial safety and bleeding pattern of the 0.25 mg drospirenone/0.5 mg 17β-estradiol (DRSP/E2) dose combination compared with 0.5...” PMID 23531117 ↗ May 201323“Women with TS were treated with oral hormone substitution consisting of 2 mg 17β-estradiol/day for days 1-12, 2 mg 17β-estradiol/day and 1 mg norethisterone acetate/day for...” NCT00825617 ↗ “Ryeqo® consists of an oral treatment, available as a pill, which contains 40 mg of the GnRH antagonist Relugolix, combined with 1 mg of oestradiol and a progestin, such as...” NCT07173127 ↗ “Group B administered ½ Evorel Conti patches - trans-dermal Estradiol 25 mcg/norethisterone acetate 85 mcg (½ Evorel Conti patches) daily for the duration of the treatment phase...” NCT02264743 ↗ “They received daily estradiol hemihydrate (E2) 2mg + norethisterone acetate (NETA) 1mg (Kliogest®, Novo Nordisk, Denmark) and were randomized to get additional Boneplac” NCT00877097 ↗ “Activelleâ, estradiol (E2) 1 mg and norethisterone acetate (NETA) 0.5 mg per tablet, was supplied as uncoded tablets.” NCT00431093 ↗ “NETA-EE film-coated oral tablets containing 1 mg norethisterone acetate and 10 μg ethinylestradiol.” NCT01656434 ↗ “progestin Norethisterone acetate 10mg once daily (oral tablets).” NCT01156857 ↗ “progestin Norethisterone acetate 10mg once daily (oral tablets)” NCT01252069 ↗ “estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg” NCT03986944 ↗ “estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg” NCT05894135 ↗ |
| Known as | Noriday | “Norethindrone/ Noriday” NCT03353857 ↗ |
| Known as | NTA | “Norethindrone acetate (NTA)” NCT04676061 ↗ |
| Action | Inhibit | “Norethindrone downregulates estrogen receptors on the endometrium lining preventing endometrial proliferation” NCT03594604 ↗ |
| Route | Oral | “oral contraceptives (triphasic ethinyl estradiol at a dose of 35 microg plus norethindrone” PMID 16354891 ↗ Dec 2005 |