Drugs / Ortho Tri-Cyclen
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ORTHO TRI-CYCLEN | — | 1992-07-03 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04718636 | Sep 2020 → Aug 2021 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT00983957 | Oct 2009 → Feb 2010 | chronic hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT01063023 Comparator | Jan → Jun 2010 | hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00549666 Comparator | Aug → Dec 2007 | — | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| — | NCT00775190 Comparator | Oct 2008 → Oct 2013 | — | Corewell Health East | Terminated | No outcome recorded Stop: Enrollment |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ortho tricyclen | “Ortho tricyclen™” NCT00775190 ↗ |
| Known as | Ortho Tri- Cyclen (R) | “Effect of BMS-650032 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri- Cyclen (R)) in Healthy Female Subjects” NCT01063023 ↗ |
| Route | Oral | “Participant Randomized to Ortho tricyclen 1 tablet by mouth Daily” NCT00775190 ↗ |