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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)

FSH and LH Versus FSH Alone for Ovarian Stimulation in Non-hormone Sensitive Onco-fertility Patients

Phase 3
Not yet recruiting
Conditions
Fertility Preservation
Interventions
First Posted Date
2024-01-29
Last Posted Date
2024-01-29
Lead Sponsor
Ellen Greenblatt
Target Recruit Count
140
Registration Number
NCT06227949

Effect of LH Supplementation on the Endometrial Gene Expression Profile in Poor Ovarian Responders

Phase 4
Withdrawn
Conditions
Poor Response to Ovulation Induction
Interventions
Diagnostic Test: Endometrial biopsy
First Posted Date
2022-06-06
Last Posted Date
2024-02-28
Lead Sponsor
CRG UZ Brussel
Registration Number
NCT05405686

Pergoveris FD and Liquid China BE Study

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2021-05-24
Last Posted Date
2022-06-15
Lead Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Target Recruit Count
72
Registration Number
NCT04899193
Locations
🇨🇳

Xuanwu Hospital, Capital Medical University, Beijing, China

Rec-LH PD and Safety Profile in Hypogonadotropic Hypogonadism Men

Phase 2
Recruiting
Conditions
Acquired Hypogonadotropic Hypogonadism
Interventions
First Posted Date
2019-12-06
Last Posted Date
2023-07-20
Lead Sponsor
Azienda Ospedaliero-Universitaria di Modena
Target Recruit Count
32
Registration Number
NCT04189133
Locations
🇮🇹

Fondazione IRCCS Ca ' Grande Ospedale Maggiore Policlinico, Milan, Italy

🇮🇹

Unit of Endocrinology of Modena, Modena, Italy

🇮🇹

Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università degli Studi di Napoli "Federico II", Naples, Italy

and more 2 locations

Double Ovarian Stimulation as Accumulation Strategy for Older Infertile Patients With Suboptimal Ovarian Response

Phase 4
Conditions
In Vitro Fertilisation
Infertility, Female
Ovarian Stimulation
Interventions
First Posted Date
2018-01-17
Last Posted Date
2018-01-17
Lead Sponsor
Nova Clinic, Russia
Target Recruit Count
120
Registration Number
NCT03400722
Locations
🇷🇺

Irina Zorina, Moscow, Russian Federation

Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-12-16
Last Posted Date
2018-07-16
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
34
Registration Number
NCT02317809
Locations
🇩🇪

Please contact the Merck KGaA Communication Center, Darmstadt, Germany

Efficacy of Pergoveris in Aged IVF Patients

Not Applicable
Completed
Conditions
Infertility
Interventions
First Posted Date
2014-09-19
Last Posted Date
2014-12-25
Lead Sponsor
Vietnam National University
Target Recruit Count
240
Registration Number
NCT02244866
Locations
🇻🇳

An Sinh Hospital, Ho Chi Minh, Vietnam

Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation in Patients With Hypogonadotropic Hypogonadism

Phase 4
Conditions
Infertility
Interventions
First Posted Date
2014-05-16
Last Posted Date
2015-05-06
Lead Sponsor
Royan Institute
Target Recruit Count
90
Registration Number
NCT02140515
Locations
🇮🇷

Royan Institute, Tehran, Iran, Islamic Republic of

Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)

Phase 3
Completed
Conditions
Infertility
Interventions
Drug: GONAL-f®
Drug: Recombinant human chorionic gonadotrophin (r-hCG)
First Posted Date
2014-01-28
Last Posted Date
2017-08-24
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
939
Registration Number
NCT02047227
Locations
🇩🇪

Please contact the Merck KGaA Communication Center, Darmstadt, Germany

A Study to Evaluate Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH) Compared With Urinary Human Chorionic Gonadotrophin (u-hCG) to Trigger Ovulation in Infertile Women

Phase 2
Completed
Conditions
Infertility
Interventions
Drug: r-hFSH
Drug: u-hCG
First Posted Date
2012-11-28
Last Posted Date
2014-02-04
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
67
Registration Number
NCT01735422
Locations
🇨🇦

Royal University Hospital, Saskatoon, Saskatchewan, Canada

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