Drugs / Ovidrel
Ovidrel
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Ovitrelle | — | 2001-02-02 | europa.eu ↗ |
| Approved | US (FDA) | OVIDREL | — | 2000-09-20 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07557615 | Oct 2026 → Jul 2029 expected | traumatic brain injury | VA Office of Research and Development | Not yet recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT06599528 | Aug 2024 → Jun 2026 overdue | female infertility | Suzhou Centergene Pharmaceuticals Co.,Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT01851512 | May → Aug 2010 | infertility disorder | Dong-A Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07108621 | Jan 2026 → Mar 2028 expected | female infertility, ovarian dysfunction | Kristine Loessl | Recruiting | No outcome recorded |
| Phase 44 trials · 1 missed | ||||||
| Phase 4 | NCT04643925 | Dec 2020 → Aug 2021 | female infertility, ovarian dysfunction | Rigshospitalet, Denmark | Completed | Missed primary |
| Phase 4 | NCT02825290 | Jul 2016 → Jun 2017 | — | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT03495609 | Feb 2016 → Dec 2018 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT01504139 | Jan 2012 → Apr 2014 | infertility disorder | Regionshospitalet Viborg, Skive | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07425990 | Mar 2026 → Feb 2027 expected | female infertility | University of Novi Sad | Recruiting | No outcome recorded |
| — | NCT07028710 | Jan 2026 → Jun 2028 expected | — | University Hospital, Montpellier | Recruiting | No outcome recorded |
| — | NCT01668056 | Jan 2012 → Dec 2014 | infertility disorder | University of Sao Paulo General Hospital | Unknown | No outcome recorded |
| — | NCT01406600 | Sep 2011 → Nov 2013 | — | Seoul National University Hospital | Unknown | No outcome recorded |
| Comparator or background therapy15 trials | ||||||
| Phase 0 | NCT05450900 Comparator | Oct 2022 → Feb 2023 | — | Sports Medicine Research and Testing Laboratory | Completed | No outcome recorded |
| Phase 2 | NCT05571111 Comparator | Oct 2022 → Mar 2024 | infertility disorder | Ferring Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT02890082 Background | Feb 2014 → Jul 2017 overdue | female breast carcinoma | Institut Cancerologie de l'Ouest | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT03440359 Background | Jul 2012 → Nov 2016 | polycystic ovary syndrome | Eastern Virginia Medical School | Completed | No outcome recorded |
| Phase 3 | NCT02047227 Background | Jan 2014 → Aug 2015 | infertility disorder | Merck KGaA, Darmstadt, Germany | Completed | Missed primary |
| Phase 4 | NCT06875752 Comparator | Apr 2025 → Apr 2026 overdue | — | Dunamenti REK Istenhegyi IVF Center | Recruiting | No outcome recorded |
| Phase 4 | NCT06896617 Comparator | Feb 2025 → Nov 2026 expected | infertility disorder | Fundacion Clinic per a la Recerca Biomédica | Recruiting | No outcome recorded |
| Phase 4 | NCT04719000 Background | Feb 2021 → Aug 2027 expected | infertility disorder | Fundacion Dexeus | Recruiting | No outcome recorded |
| Phase 4 | NCT00804960 Comparator | Sep 2008 → Dec 2009 | infertility disorder | Center for Human Reproduction | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01210144 Background | Aug 2008 → Aug 2010 | — | Merck KGaA, Darmstadt, Germany | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00328926 Comparator | Mar 2006 → May 2012 | hypogonadotropic hypogonadism | EMD Serono | Terminated | No outcome recorded |
| — | NCT04717752 Background | Jan → Oct 2021 | ovarian dysfunction | Nanjing University | Unknown | No outcome recorded |
| — | NCT03660813 Background | Jul 2018 → Aug 2021 | — | Sheba Medical Center | Completed | No outcome recorded |
| — | NCT03540979 Background | Jun 2018 → Dec 2019 | — | Meir Medical Center | Unknown | No outcome recorded |
| — | NCT01205009 Comparator | Apr 2011 → Mar 2012 | infertility disorder | Hadassah Medical Organization | Unknown | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ovidrel | “Choriogonadotropin alfa (Ovidrel®) is a recombinant hCG (rhCG) preparation derived from genetically engineered Chinese hamster ovary cells” NCT01406600 ↗8“Ovidrel liquid injection is injected first and DA-3803 Injection is injected after 3-week period” NCT01851512 ↗ “SJ04 is a biosimilar of Ovidrel® and is highly similar to Ovidrel®.” NCT06599528 ↗ “Oocyte maturation will be triggered by 250 micg of ovidrel.” NCT00804960 ↗ “Ovidrel®” NCT02047227 ↗ |
| Known as | choriogonadotropin alfa | “When the follicular response will adequate, ovulation will be triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG,...” NCT00328926 ↗3“Choriogonadotropin alfa (Ovidrel®) is a recombinant hCG (rhCG) preparation derived from genetically engineered Chinese hamster ovary cells” NCT01406600 ↗ |
| Known as | Choriogonadotropin Alpha | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05450900 ↗ |
| Known as | Choriongonadotropin alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07108621 ↗ |
| Known as | Drug: Ovidrel liquid injection (Referecne drug) | “Drug: Ovidrel liquid injection (Referecne drug)” NCT01851512 ↗ |
| Known as | hCG | “Choriongonadotropin alfa (hCG)” NCT07108621 ↗ |
| Known as | Ovitrelle | “hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase” NCT01504139 ↗11“Recombinant human chorionic gonadotropin (rhCG) 6500 IU (Ovitrelle® - Merck)” NCT04719000 ↗ “Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria” NCT02890082 ↗ “Subcutaneous injection of 250 µg of recombinant hCG (Ovitrelle®)” NCT07028710 ↗ “hCG (250 mcg recombinant hCG, Ovitrelle)” NCT06875752 ↗ “Ovitrelle ( Hcg 250 mcg)” NCT06896617 ↗ “Ovitrelle ( Hcg 250 mcg)” NCT03660813 ↗ |
| Known as | r-hCG | “hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase” NCT01504139 ↗3“Recombinant human chorionic gonadotropin (rhCG) 6500 IU (Ovitrelle® - Merck)” NCT04719000 ↗ “Drug: Choriogonadotropin alpha (r-hCG)” NCT07425990 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa).” NCT00328926 ↗ |
| Route | Subcutaneous | “a single 250 microgram subcutaneous injection” NCT00328926 ↗ |