Bravelle
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | BRAVELLE | — | 2014-02-19 | fda.gov ↗ |
| Label expansions (3) | US (FDA) | FERTINEX | — | 1988-03-01 – 1996-08-23 | fda.gov ↗ |
| Approved | US (FDA) | FERTINEX | — | 1986-09-18 | fda.gov ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 35 trials · 1 missed | ||||||
| Phase 3 | NCT02605070 | Nov 2015 → Jun 2017 | male infertility | La Fe Health Research Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02275169 | Feb 2015 → Feb 2016 | azoospermia | Azienda Sanitaria Locale Bari | Unknown | No outcome recorded |
| Phase 3 | NCT02739516 | Jun 2014 → Aug 2015 | infertility disorder | Benha University | Completed | No outcome recorded |
| Phase 3 | NCT00971152 | Sep 2009 → Oct 2013 | infertility disorder | Clinique Ovo | Completed | Missed primary |
| Phase 3 | NCT00378001 | Mar 2005 → May 2006 | female infertility | IBSA Institut Biochimique SA | Completed | No outcome recorded |
| Phase 43 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT01969201 | Jan 2014 → Jun 2016 | infertility disorder | IBSA Institut Biochimique SA | Completed | Missed primary |
| Phase 4 | NCT01417195 | Jul 2011 → Jan 2012 | infertility disorder | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00854373 | Jun 2007 → Apr 2010 | infertility disorder | University of California, San Francisco | Completed | Met primary |
| Phase not applicable2 trials · 1 missed | ||||||
| — | NCT01882166 | Oct 2013 → Jan 2015 | female infertility | St. Olavs Hospital | Terminated | No outcome recorded |
| — | NCT01157312 | Aug 2008 → Apr 2010 | polycystic ovary syndrome | Mansoura University | Completed | Missed primary |
| Comparator or background therapy12 trials | ||||||
| Phase 1 | NCT01477073 Comparator | Oct 2011 → Apr 2012 | female infertility | Glycotope GmbH | Completed | No outcome recorded |
| Phase 1 | NCT01354886 Comparator | Apr → Oct 2011 | female infertility | Glycotope GmbH | Completed | No outcome recorded |
| Phase 2 | NCT04268927 Comparator | Apr 2018 → Mar 2020 | infertility disorder | Cairo University | Unknown | No outcome recorded |
| Phase 2 | NCT01337531 Comparator | May → Nov 2011 | polycystic ovary syndrome | Genesis Center for Fertility & Human Pre-Implantation Genetics | Unknown | No outcome recorded |
| Phase 3 | NCT04537078 Comparator | Sep 2020 → Mar 2021 | female infertility | El Shatby University Hospital for Obstetrics and Gynecology | Completed | No outcome recorded |
| Phase 3 | NCT02304536 Comparator | Nov 2014 → Dec 2017 | infertility disorder | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT02304107 Comparator | May 2013 → Jan 2015 | infertility disorder | Cairo University | Completed | No outcome recorded |
| Phase 3 | NCT01185782 Comparator | Feb → Dec 2007 | female infertility | Merck KGaA, Darmstadt, Germany | Completed | Met primary |
| Phase 3 | NCT00335725 Comparator | Mar 2003 → Dec 2005 | infertility disorder | IBSA Institut Biochimique SA | Completed | No outcome recorded |
| Phase 4 | NCT04834791 Comparator | Mar → Oct 2019 | female infertility | Tanta University | Completed | No outcome recorded |
| — | NCT01669291 Comparator | Jul 2012 → May 2014 | infertility disorder | Main Line Fertility Center | Completed | No outcome recorded |
| — | NCT00677573 Comparator | May → Oct 2008 | infertility disorder | German Hospital, Istanbul | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2020-07-09 | IBSA Institut Biochimique SA | Regulatory China, the last frontier: IBSA’s much-anticipated return to the market ibsagroup.com ↗
There’s no use hiding it; re-launching onto the Chinese market has been a painful experience and it has taken a long time to get the go-ahead from the Regulatory Authority |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2020-07-09 | IBSA Institut Biochimique SA | China, the last frontier: IBSA’s much-anticipated return to the market ibsagroup.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bravelle | “Bravelle 150 IU QD” NCT01477073 ↗ |
| Known as | follicle-stimulating hormone | “Bravelle(follicle stimulating hormone)” NCT00854373 ↗ |
| Known as | Fostimon | “The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous FSH preparations (Fostimon®, IBSA vs Gonal-F®, Serono Inc.)” NCT00378001 ↗12“Group 1 will receive urinary purified FSH (Fostimon® IBSA, Switzerland) 75IU daily for 7 days starting from the 3rd day of menstruation or progesterone withdrawal bleeding.” NCT02304107 ↗ “Highly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 5 and is continued until and including the day of HCG administration.” NCT04268927 ↗ “In group A (minimal stimulation), 2 vials of highly purified uFSH , 150 IU (Fostimon; IBSA, Lugano, Switzerland, 75 IU/vial) were given IM on cycle day 9.” NCT01157312 ↗ “FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once intramuscular when the mean ovarian follicle diameter was ≥18 mm.” NCT02739516 ↗ “stimulation of egg production by human urine derived FSH (Fostimon®)” NCT01882166 ↗ “urofollitropin (fostimon ®, IBSA, Lugano, Switzerland)” NCT04834791 ↗ “urinary purified FSH (Fostimon® IBSA, Switzerland)” NCT02304536 ↗ “Fostimon is an highly purified FSH preparation.” NCT00335725 ↗ “Fostimon” NCT04537078 ↗ |
| Known as | FSH | “Highly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 5 and is continued until and including the day of HCG administration.” NCT04268927 ↗3“FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once intramuscular when the mean ovarian follicle diameter was ≥18 mm.” NCT02739516 ↗ |
| Known as | HP-uFSH | “Highly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 5 and is continued until and including the day of HCG administration.” NCT04268927 ↗ |
| Known as | uFSH | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01157312 ↗ |
| Known as | Urofollitrophin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01969201 ↗ |
| Known as | Urofollitropin | “PURPOSE: We aimed to compare the efficacy and safety of recombinant human follicle-stimulating hormone (follitropin alfa) and purified urinary human follicle-stimulating...” PMID 29699333 ↗ Feb 20104“FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once intramuscular when the mean ovarian follicle diameter was ≥18 mm.” NCT02739516 ↗ “These patients were given urofollitropin (fostimon ®, IBSA, Lugano, Switzerland)” NCT04834791 ↗ |
| Modality | Protein / enzyme biologic | “Fostimon is an highly purified FSH preparation.” NCT00335725 ↗ |
| Route | Subcutaneous | “subcutaneous injection of FSH.” NCT00335725 ↗ |