Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Evra | — | 2002-08-22 | europa.eu ↗ |
| Approved | US (FDA) | ORTHO EVRA | — | 2001-11-20 | fda.gov ↗ |
Trials 16 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04423068 | Dec 2020 → Apr 2022 | pregnancy disorder | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT04017195 | Jul → Dec 2019 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01535820 | Mar → Jul 2011 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00258063 | May → Sep 2004 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00258076 | Apr → Sep 2004 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00254865 | Aug 2002 → Mar 2003 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07365904 | Dec 2025 → Nov 2026 expected | — | Mylan Pharmaceuticals Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT07083635 | Jul 2025 → Sep 2026 expected | hemometra, menstrual disorder | Chulalongkorn University | Recruiting | No outcome recorded |
| Phase 2 | NCT06048536 | Dec 2023 → Jan 2024 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05139121 | Oct 2021 → Jan 2025 | — | Mylan Technologies Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00236769 | Nov 1997 → Oct 1999 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00236782 | Oct 1997 → Mar 1999 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00236795 | Jan 1997 → Mar 1999 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT02367833 | Jan 2015 → Dec 2017 | bone disorder | Penn State University | Completed | No outcome recorded |
| Phase 4 | NCT00261482 | Jul 2003 → Dec 2004 | — | Janssen Pharmaceutica N.V., Belgium | Completed | No outcome recorded |
| Phase 4 | NCT00653016 | Oct 2002 → Aug 2003 | — | Janssen-Ortho Inc., Canada | Completed | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00439972 Comparator | Feb 2007 → Dec 2011 | — | University of Washington | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT00984789 Comparator | May 2009 → Sep 2010 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00185354 Comparator | Nov 2004 → Apr 2006 | — | Bayer | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01044056 Comparator | Mar → Jun 2004 | — | Organon and Co | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01087879 Comparator | Oct 2007 → Jan 2011 | — | University of Oulu | Completed | No outcome recorded |
| — | NCT00554632 Comparator | Apr 2003 → Aug 2005 | venous thromboembolism | University of Vermont | Completed | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | norelgestromin | “ORTHO EVRA is a combination transdermal (through the skin) contraceptive patch containing 6.00 mg of the progestin norelgestromin (NGMN) and 0.75 mg of the estrogen, ethinyl...” NCT01535820 ↗21“Participants in the TDC group will apply a 20 cm2 patch (Xulane: 20µg/d EE,150µg/d norelgestromin) to the abdomen, upper arm or buttock.” NCT02367833 ↗ “0.9 mg Ethinylestradiol/1.9 mg Gestodene) vs. a Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin)” NCT00185354 ↗ “MR-130A-01 transdermal patch, containing 2.43 mg Norelgestromin, will be worn 28 days per cycle with no patch free period.” NCT06048536 ↗ “Ortho-Evra® contains 0.75 mg ethinyl estradiol and 6 mg norelgestromin in each 20 cm square patch.” NCT00439972 ↗ “exposure to the hormones norelgestromin, norgestrel, and ethinyl estradiol in the bloodstream” NCT00258076 ↗ “MR-100A-01 is a TDS of norelgestromin 4.86 mg/ethinyl estradiol 0.264 mg.” NCT05139121 ↗ “Norelgestromin/Ethinyl estradiol transdermal patch (Ortho Evra)” NCT04423068 ↗ “norelgestromin [NGMN] and ethinyl estradiol [EE]” NCT04017195 ↗ |
| Known as | NGMN | “ORTHO EVRA® is a combination, monophasic transdermal contraceptive patch containing 6 mg of norelgestromin (NGMN) and 0.75 mg of ethinyl estradiol (EE), and delivering to the...” NCT00254865 ↗4“OBJECTIVE(S): To investigate the bleeding pattern and cycle control parameters of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD)...” PMID 25453582 ↗ Oct 2014 “ORTHO EVRA is a combination transdermal (through the skin) contraceptive patch containing 6.00 mg of the progestin norelgestromin (NGMN) and 0.75 mg of the estrogen, ethinyl...” NCT01535820 ↗ “MR-130A-01 contraceptive transdermal patch, containing norelgestromin (NGMN)” NCT07365904 ↗ “norelgestromin [NGMN] and ethinyl estradiol [EE]” NCT04017195 ↗ |
| Route | Other | “Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin)” NCT00185354 ↗ |