Drugs / Ortho-Cyclen
Ortho-Cyclen
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | SPRINTEC | — | 2002-09-25 | fda.gov ↗ |
Trials 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02157467 | Jun → Aug 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01746732 | Dec 2012 → May 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01498861 | Dec 2011 → Mar 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01458210 | Oct 2011 → Feb 2012 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00901290 | May → Sep 2009 | — | AstraZeneca | Suspended | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01243580 Comparator | Aug → Dec 2009 | — | Agile Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00399685 Comparator | Dec 2006 → Aug 2007 | HIV infectious disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04039204 Comparator | Jan 2022 → Aug 2023 | endometriosis, infertility disorder | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00130117 Background | Apr 2010 → Aug 2011 | amenorrhea | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ortho-Cyclen | “Ortho-Cyclen (OC)” NCT01458210 ↗ |
| Known as | monophasic oral contraceptive | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00901290 ↗ |
| Known as | Sprintec | “Sprintec taken orally once daily.” NCT00130117 ↗ |
| Route | Oral | “Sprintec taken orally once daily.” NCT00130117 ↗ |