MedPath

Lutropin alfa

Generic Name
Lutropin alfa
Brand Names
Luveris, Pergoveris
Drug Type
Biotech
CAS Number
152923-57-4
Unique Ingredient Identifier
3JGY52XJNA
Background

Lutropin alfa is a recombinant human luteinizing hormone produced in yeast with 2 subunits, alpha = 92 residues, beta = 121 residues. It is a heterodimeric glycoprotein made up of monomeric units. Lutropin alfa was the first and only recombinant human form of luteinizing hormone (LH) developed for use in the stimulation of follicular development. Its pharmacological action mimics the biological activity of endogenous LH; an acute rise of LH, or LH surge, in females triggers ovulation and the development of the corpous luteum. In males, LH stimulates Leydig cell to produce testosterone.

Indication

For treatment of infertility in women with hypothalamic or pituitary insufficiency (hypogonadotropic hypogonadism) and profound LH deficiency (LH <1.2 international units [IU]/L)

Comparing Ovarian Stimulation for Assisted Reproduction With Two Different Forms of Pituitary Suppression

Not Applicable
Completed
Conditions
Female Infertility Due to Nonimplantation of Ovum
Complications Associated With Artificial Fertilization
Interventions
First Posted Date
2012-03-28
Last Posted Date
2017-05-01
Lead Sponsor
University Hospital, Basel, Switzerland
Target Recruit Count
5
Registration Number
NCT01565265
Locations
🇨🇭

University Hospital of Basel, Basel, Switzerland

A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique

Phase 3
Terminated
Conditions
Fertility
Infertility
Follicle Stimulating Hormone Deficiency
Interventions
Drug: GONAL-f®
Biological: Recombinant human chorionic gonadotropin (r-hCG)
First Posted Date
2011-12-22
Last Posted Date
2015-11-09
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
174
Registration Number
NCT01497197
Locations
🇦🇪

Merck Serono Research Site, Dubai, United Arab Emirates

A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)

Completed
Conditions
Infertility
First Posted Date
2011-08-15
Last Posted Date
2019-07-19
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
600
Registration Number
NCT01416987
Locations
🇰🇷

Research site, Seoul, Korea, Republic of

PERgoveriS In Stratified Treatment for Assisted Reproductive Technique

Phase 3
Completed
Conditions
Assisted Reproductive Techniques
Reproductive Technology, Assisted
Interventions
Drug: Gonal-f®
Drug: Recombinant human chorionic gonadotropin (r-hCG)
First Posted Date
2011-02-16
Last Posted Date
2021-05-28
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
202
Registration Number
NCT01297465
Locations
🇬🇧

Research Site, Swansea, United Kingdom

Lutropin Alfa in Women at Risk of Poor Response

Phase 2
Completed
Conditions
Ovarian Stimulation
Interventions
Drug: r-FSH
Drug: Analogous GnRH antagonist
Drug: r-hCG
First Posted Date
2010-04-28
Last Posted Date
2018-08-28
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
58
Registration Number
NCT01112358
Locations
🇪🇸

Hospital Universitario de La Fe, Valencia, Spain

To Describe the Effect of rhLH Supplementation in Women With Hyporesponse to rhFSH After Pituitary Downregulation

Phase 2
Conditions
Infertility
Interventions
First Posted Date
2009-12-10
Last Posted Date
2009-12-10
Lead Sponsor
Peking University Third Hospital
Target Recruit Count
150
Registration Number
NCT01029470
Locations
🇨🇳

Peking University third Hospital, Beijing, Beijing, China

The Luveris In Vitro Fertilization Trial

Phase 4
Terminated
Conditions
Infertility
Hypothalamic Amenorrhea
Hyperprolactinemia
Interventions
First Posted Date
2009-04-29
Last Posted Date
2018-08-07
Lead Sponsor
University Reproductive Associates
Target Recruit Count
14
Registration Number
NCT00889512
Locations
🇺🇸

University Reproductive Associates, Hasbrouck Heights, New Jersey, United States

Synchronization of Follicle Wave Emergence and Ovarian Stimulation

Phase 4
Completed
Conditions
Infertility
Interventions
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

Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])

Phase 4
Terminated
Conditions
Hypogonadotropic Hypogonadism
Interventions
Drug: Placebo
Drug: Recombinant human follicle stimulating hormone (r-hFSH)
Drug: Recombinant human chorionic gonadotropin (r-hCG)
First Posted Date
2006-05-24
Last Posted Date
2013-08-07
Lead Sponsor
EMD Serono
Target Recruit Count
11
Registration Number
NCT00328926
Locations
🇺🇸

U.S. Medical Information, 1-888-275-7376, Rockland, Massachusetts, United States

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