Drugs / r-hFSH
r-hFSH
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT00749853 | May 2015 | infertility disorder | Medical University of Vienna | Suspended | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01223079 | Dec 2005 → Dec 2007 | — | Reproductive Medicine Associates of New Jersey | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT01079949 Comparator | Nov 2007 → Oct 2010 | female infertility | Merck KGaA, Darmstadt, Germany | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT01735422 Background | Dec 1999 → Jul 2001 | female infertility | Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 4 | NCT04719000 Background | Feb 2021 → Aug 2027 expected | infertility disorder | Fundacion Dexeus | Recruiting | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2001-05-16 | Alkermes, Inc. | Alkermes and Serono to Proceed With Development of Long-acting Formulation of Recombinant Human Follicle Stimulating Hormone (R-hFSH) alkermes.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | r-hFSH | “Treatment with r-hFSH (Gonal-F®, Serono Austria GmbH, Vienna, Austria) will be started in women with serum E2 concentrations \<200 pmol/l and no follicles \>15 mm in diameter...” NCT00749853 ↗ |
| Known as | Gonal-F | “Treatment with r-hFSH (Gonal-F®, Serono Austria GmbH, Vienna, Austria) will be started in women with serum E2 concentrations \<200 pmol/l and no follicles \>15 mm in diameter...” NCT00749853 ↗ |
| Known as | recombinant FSH | “receiving recombinant FSH (rhFSH) versus rhFSH and rhLH for ovarian stimulation.” NCT04719000 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant human follicle stimulating hormone (r-hFSH)” NCT01079949 ↗ |
| Route | Subcutaneous | “The initial r-hFSH dose will be 250 IU s.c. daily for 5 days, after which the dose will be increased to a maximum of 450 IU per day using a step-up protocol with steps of 50 IU/day.” NCT00749853 ↗ |