Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Zoely | — | 2011-07-26 | europa.eu ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT00779532 | May → Nov 2008 | — | Organon and Co | Completed | Met primary |
| Phase 1 | NCT00711607 | May → Sep 2007 | — | Organon and Co | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT01670656 | Jan → Sep 2013 | dysmenorrhea | Organon and Co | Completed | Met primary |
| Phase 2 | NCT01709318 | Dec 2012 → Oct 2013 | — | Organon and Co | Completed | Missed primary |
| Phase 2 | NCT01361958 | Feb → Nov 1997 | anovulation | Theramex | Completed | No outcome recorded |
| Phase 39 trials · 1 missed | ||||||
| Phase 3 | NCT05264506 | Feb 2022 → Jan 2024 | — | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01723579 | Jul 2013 → May 2015 | — | Organon and Co | Withdrawn | No outcome recorded |
| Phase 3 | NCT01656434 | Nov 2012 → Feb 2014 | — | Organon and Co | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00511355 | Oct 2006 → Jan 2008 | — | Organon and Co | Completed | Mixed |
| Phase 3 | NCT00511433 | Oct 2006 → Jan 2008 | — | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00511342 | Sep 2006 → Jun 2009 | — | Organon and Co | Completed | Missed primary |
| Phase 3 | NCT00413062 | Jun 2006 → Aug 2008 | — | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00511199 | May 2006 → Apr 2008 | — | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00127075 | Jun 2005 → Apr 2012 | multiple sclerosis | Hospices Civils de Lyon | Unknown | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06316219 | Jan → Aug 2023 | endometrial polyp | University of Palermo | Completed | No outcome recorded |
| Phase 4 | NCT06324851 | Jan → Aug 2023 | endometrial polyp | University of Palermo | Completed | No outcome recorded |
| Phase 4 | NCT03077555 | Jan 2017 → Feb 2018 | anovulation | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT01715025 | Apr 2013 → Apr 2015 | menstrual disorder | Sydney Centre for Reproductive Health Research | Unknown | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT01603745 Comparator | Apr → May 2012 | polycystic ovary syndrome | Catholic University of the Sacred Heart | Unknown | No outcome recorded |
| Phase 4 | NCT03531437 Comparator | Mar 2016 → Jan 2018 | thrombophilia | Mahidol University | Terminated | No outcome recorded Stop: Enrollment |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nomegestrol Acetate | “Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day...” NCT00511342 ↗18“Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day...” NCT00413062 ↗ “Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive...” NCT00511355 ↗ “An Open-labeled Pilot Study to Determine the Efficacy of an E2//Nomegestrol Acetate (E2/NOMAC)Combination Oral Contraceptive (COC) in the Management of Heavy Menstrual Bleeding (HMB)” NCT01715025 ↗ “Nomegestrol acetate (NOMAC)/17β-estradiol (E2) is a monophasic oral contraceptive that contains a progesterone-derived progestogen (NOMAC), and E2, a bio-identical estrogen.” PMID 24777591 ↗ Jun 2014 “Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28” NCT00511433 ↗ “quick start of combined hormonal contraception containing 1.5 mg estradiol /2.5 mg nomegestrol acetate” NCT03077555 ↗ “Minimal Effective Dose of Nomegestrol Acetate Inhibiting the Ovulation in Women Receiving Estradiol” NCT01361958 ↗ “NOMAC-E2 film-coated oral tablets containing 2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol.” NCT01656434 ↗ “2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC” NCT00511199 ↗ “Nomegestrol acetate (NOMAC) 2.5 mg and estradiol (E2) 1.5 mg” NCT05264506 ↗ |
| Known as | NOMAC | “To evaluate the effect of investigational vaginal rings containing
nomegestrol acetate (NOMAC) plus 17β-estradiol (E2) or etonogestrel (ENG) plus E2 in women with moderate to...” PMID 30439359 ↗ Nov 201810“Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day...” NCT00511342 ↗ “Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day...” NCT00413062 ↗ “Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive...” NCT00511355 ↗ “Nomegestrol acetate (NOMAC)/17β-estradiol (E2) is a monophasic oral contraceptive that contains a progesterone-derived progestogen (NOMAC), and E2, a bio-identical estrogen.” PMID 24777591 ↗ Jun 2014 “Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28” NCT00511433 ↗ “2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC” NCT00511199 ↗ “nomegestrol acetate (NOMAC) plus 17β-estradiol (E(2)) were investigated after a” PMID 22898360 ↗ Aug 2012 “Nomegestrol acetate (NOMAC) 2.5 mg and estradiol (E2) 1.5 mg” NCT05264506 ↗ “Nomegestrol acetate (NOMAC)” NCT01723579 ↗ “Nomegestrol acetate (NOMAC)” NCT01709318 ↗ |
| Known as | NOMEGESTROL | ChEMBL registry synonym — accepted as the source's own label CHEMBL1476022 ↗ |
| Known as | ORG 10486-0 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1476022 ↗ |
| Known as | TX 066 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1476022 ↗ |
| Known as | Zoely | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01603745 ↗ |
| Action | Activate | “Progesterone receptor agonist” CHEMBL1476022 ↗ |
| Modality | Small molecule | — CHEMBL1476022 ↗ |
| Route | Oral | “combined oral contraceptive” NCT00413062 ↗ |
| Target | PGR | “Progesterone receptor agonist” CHEMBL1476022 ↗ |