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urofollitropin

Trade name: Metrodin

Biologicalapproved

Approved

Aug 22, 1975

Urofollitropin is a purified form of follicle-stimulating hormone (FSH) that is manufactured by extraction from human urine and then purified to remove various proteins and other substances. FSH is important in the development of follicles (eggs) produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. It is also used with in vitro fertilization methods. The dosage is adjusted to each individual's response. — Wikipedia

Clinical trial activity

49 trials · 52 clinical orgs · 4 marketing orgs

Phase 1
3
Phase 2
15
Phase 3
12
Phase 4
22

Earliest trial started Jun 1, 2004 (NCT00680238)

Timeline

1970s

  1. Aug 22, 1975

    Earliest FDA Approval

  2. Aug 22, 1975

    Merck Serono — NDA Secondary Org

1980s

  1. Sep 18, 1986

    Serono — First NDA Organization

  2. Sep 18, 1986

    Serono — NDA Organization

1990s

  1. Sep 1, 1994

    Organon — NDA Secondary Org

  2. Jan 30, 1997

    Ferring — Marketing Organization

2000s

  1. May 6, 2002

    Ferring — NDA Secondary Org

  2. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedAug 22, 1975

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • bravelle
  • bravelle
  • fertinex
  • fertinex
  • fertinorm-p
  • follitropin human
  • fostimon
  • fostimon
  • gonadotraphon fsh
  • hmg-ibsa
  • human lh
  • human lh
  • menopur
  • menopur
  • menopure
  • menotrophin
  • menotrophin
  • menotrophin
  • menotropin
  • menotropins
  • menotropins
  • menotropins (fsh;lh)
  • merional
  • merional
  • merional
  • metrodin
  • metrodin
  • metrodin
  • metrodin high purity
  • metrodin high purity
  • orgafol
  • urinary follicle stimulating hormone
  • urinary fsh
  • urofollitrophin
  • urofollitrophin
  • urofollitrophin
  • urofollitrophin
  • urofollitropin
  • urofollitropin
  • urofollitropin
  • urofollitropin
  • urofollitropin
  • urofollitropin
  • urofollitropin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05362799Phase 4Jun 1, 2022Menoufia University
NCT03177538Phase 4Jun 1, 2017D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
NCT02992808Phase 4Dec 1, 2016Tel Aviv University
NCT02865681N/AJul 1, 2016New Hope Fertility Center
NCT02544191Phase 2Dec 1, 2015Jinlin University, Nanjing University
NCT03098199N/AOct 22, 2015Reproductive Specialists of New York
NCT02554279Phase 4Aug 1, 2015Ferring
NCT02510534Phase 1Jul 1, 2015Ferring, Northwest Center for Infertility and Reproductive Endocrinology
NCT02470169Phase 3Jun 1, 2015Cairo University
NCT02461173Phase 3Jun 1, 2015Cairo University
NCT02469805Phase 3Jun 1, 2015Cairo University
NCT02418533N/AMar 1, 2015Main Line Fertility Center
NCT02275169Phase 3Feb 1, 2015ASL Bari, Minia University, University of Bari, University of Illinois at Chicago
NCT02213627Phase 4Oct 1, 2014IVI Madrid, University Alicante, University of Valencia
NCT02099916Phase 2/Phase 3 (Phase 3)Oct 1, 2014Lito Maternity Hospital, University of Athens
NCT02307994Phase 4Aug 1, 2014Livzon Pharmaceutical Group Inc., Peking University
NCT02069808Phase 4Apr 1, 2014Michigan Reproductive Medicine
NCT01969201Phase 4Jan 1, 2014Free University of Brussels, IBSA Institut Biochimique SA, Universidad Autonoma de Barcelona
NCT01922193Phase 3Oct 1, 2013Ferring
NCT01882166N/AOct 1, 2013Norwegian University of Science and Technology
Showing 20 of 49 trials
Page 1 / 3

Organizations

Research & Development (52)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
FerringFor profit13942005
Free University of BrusselsAcademic/Hospital5432010
Cairo UniversityAcademic/Hospital3312015
University of ValenciaAcademic/Hospital3212005
IBSA Institut Biochimique SAFor profit2222011
Magna Graecia UniversityAcademic/Hospital2212007
Main Line Fertility CenterAcademic/Hospital2212012
University of CopenhagenAcademic/Hospital2112010
University of Naples Frederico IIAcademic/Hospital2012007
Aagaard Fertility ClinicAcademic/Hospital1012011
Aarhus UniversityAcademic/Hospital1112011
ASL BariAcademic/Hospital1012015
Bahceci Women Health Care CenterAcademic/Hospital1012008
Braedstrup HospitalAcademic/Hospital1012011
Catholic University of Sacred Heart, RomeAcademic/Hospital1112012
Central Jutland Regional HospitalAcademic/Hospital1112006
Centro Riproduzione e AndrologiaAcademic/Hospital1112011
clinique ovoAcademic/Hospital1112009
D.O. Ott Research Institute of Obstetrics, Gynecology, and ReproductologyAcademic/Hospital1112017
German Hospital, IstanbulAcademic/Hospital1112008
52 organizations
Page 1 / 3

Marketing (5)

OrganizationOrg typeRelationshipDate
FerringFor profitNDA2May 6, 2002
FerringFor profitMKTGJan 30, 1997
Merck SeronoFor profitNDA2Aug 22, 1975
OrganonFor profitNDA2Sep 1, 1994
SeronoFor profitNDASep 18, 1986