Drugs / Norgestrel
Norgestrel
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | OPILL | — | 2023-07-13 | fda.gov ↗ |
| Approved | US (FDA) | OVRAL | — | 1968-04-16 | fda.gov ↗ |
Trials 4 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT03585712 | Jul 2018 → Apr 2020 | — | HRA Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00033358 | Feb 2002 → Oct 2007 | endometrial cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04112095 | Sep 2019 → Aug 2021 | — | HRA Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03559010 | Apr → Sep 2018 | — | HRA Pharma | Terminated | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Norgestrel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03585712 ↗ |
| Known as | Norgestrel 75 mcg | “Norgestrel 75 mcg” NCT03585712 ↗ |
| Known as | Opill | “this prospective, multicenter, randomized, crossover study assesses the effect of norgestrel 75 mcg (Opill) on cervical mucus and ovarian activity” PMID 33970869 ↗ Jun 2021 |
| Route | Oral | “taken orally” NCT03559010 ↗ |