NCT01084265

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

Clinical Trial on Application of Injectable Recombinant Human Luteinizing Hormone (Luveris®) in the Treatment of Chinese Female Patients With Hypogonadotropic Hypogonadism: A Multi-center, Open, Prospective Drug Clinical Trial for Registration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation induction in 31 Chinese female subjects with hypogonadotropic hypogonadism.

Detailed description

The objective of this prospective, open, non-comparative study was to assess the safety and efficacy of rhLH (Luveris) administered subcutaneously in follicular development during ovulation induction in Chinese female subjects with hypogonadotropic hypogonadism. The study was organized on an outpatient basis involving a single cycle of treatment. Prior to entry into the study, the diagnosis of hypogonadotropic hypogonadism was confirmed by history, by the presence or absence of specific clinical features and by measuring serum gonadotropin levels. Once a subject has signed the informed consent form and after satisfying all eligibility criteria, the subject received a combination of daily injection of recombinant human follicle-stimulating hormone (rhFSH) 150 international units (IU) plus rhLH 75 IU. After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU human chorionic gonadotropin (hCG). Luteal phase function was assessed by serum progesterone level determination.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	Recombinant human luteinizing hormone (r-hLH)	One r-hLH (75 International Units \[IU\]) injection s.c. once daily.
DRUG	Recombinant human follicle-stimulating hormone (r-hFSH)	One r-hFSH (150 IU) injection s.c. once daily.
DRUG	Human chorionic gonadotropin (hCG)	After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU hCG.

Timeline

• Start date: 2004-02-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2010-03-10
• Last updated: 2013-12-27
• Results posted: 2012-05-22

Locations

1 site across 1 country: China