Follitropin

Generic Name
Follitropin
Brand Names
Bemfola, Follistim, Gonal F, Gonal-F, Menopur, Ovaleap, Pergoveris, Puregon, GONAL-f, Rekovelle
Drug Type
Biotech
Chemical Formula
-
CAS Number
146479-72-3
Unique Ingredient Identifier
2M2GGL7HUP
Background

Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.

Indication

In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

Associated Conditions
-
Associated Therapies
Assisted Reproductive Technology therapy, Controlled Ovarian Stimulation

Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)

First Posted Date
2010-10-21
Last Posted Date
2014-03-14
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
124
Registration Number
NCT01225835
Locations
🇩🇪

IVF Zentrum, Saar, Germany

🇩🇪

Endokrinologikum Ulm, Ulm, Germany

🇩🇪

Fertility Center Berlin, Berlin, Germany

and more 5 locations

Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-05-12
Last Posted Date
2016-04-15
Lead Sponsor
Finox AG
Target Recruit Count
460
Registration Number
NCT01121666
Locations
🇦🇹

Privatspital Goldenes Kreuz, Wien, Austria

🇦🇹

IVF Zentrum Döbling, Vienna, Austria

🇨🇭

University Hospital of Zurich, Zurich, Switzerland

and more 13 locations

A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism

Phase 3
Completed
Conditions
First Posted Date
2010-03-10
Last Posted Date
2013-12-27
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
31
Registration Number
NCT01084265
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, China

Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)

Completed
Conditions
Interventions
First Posted Date
2009-06-15
Last Posted Date
2022-02-04
Lead Sponsor
Organon and Co
Target Recruit Count
384
Registration Number
NCT00920634

Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)

Completed
Conditions
Interventions
First Posted Date
2009-06-15
Last Posted Date
2022-02-04
Lead Sponsor
Organon and Co
Target Recruit Count
1664
Registration Number
NCT00920361

Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)

First Posted Date
2008-12-10
Last Posted Date
2012-01-27
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
110
Registration Number
NCT00805935
Locations
🇺🇸

Weill Cornell Medical College, New York, New York, United States

🇺🇸

Women & Infants' Hospital of RI, Providence, Rhode Island, United States

🇺🇸

Conceptions Reproductive Associates of Colorado, Littleton, Colorado, United States

and more 3 locations

MENOPUR® Versus FOLLISTIM®

First Posted Date
2008-12-04
Last Posted Date
2011-11-02
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
173
Registration Number
NCT00802360
Locations
🇺🇸

A Woman's Center for Reproductive Medicine, Baton Rouge, Louisiana, United States

🇺🇸

Huntington Reproductive Center, Pasadena, California, United States

🇺🇸

Women's Medical Research Group, LLC, Clearwater, Florida, United States

and more 4 locations

Efficacy of Ovarian Stimulation Based on FSHR Genotype Status

Phase 3
Suspended
Conditions
Interventions
First Posted Date
2008-09-09
Last Posted Date
2015-05-05
Lead Sponsor
Medical University of Vienna
Target Recruit Count
165
Registration Number
NCT00749853
Locations
🇦🇹

University of Vienna, Vienna, Austria

Synchronization of Follicle Wave Emergence and Ovarian Stimulation

First Posted Date
2007-02-26
Last Posted Date
2010-05-25
Lead Sponsor
University of Saskatchewan
Target Recruit Count
80
Registration Number
NCT00439829
Locations
🇨🇦

Genesis Fertility Centre, Vancouver, British Columbia, Canada

🇨🇦

Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan, Saskatoon, Saskatchewan, Canada

© Copyright 2024. All Rights Reserved by MedPath