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This was a prospective, open, non-comparative study to evaluate the safety and efficacy of rhLH (Luveris) administered subcutaneously in follicular development during ovulation induction in 30 Chinese female subjects with hypogonadotropic hypogonadism.
The objective of this study was to assess the safety and efficacy of r hLH (Luveris) administered subcutaneously in follicular development during ovulation induction. This was a prospective, open, non-comparative study to evaluate the safety and efficacy of Luveris administered subcutaneously in follicular development during ovulation induction in 30 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 gonadotrophin 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 r hFSH 150 IU plus r hLH 75 IU. After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU hCG. Luteal phase function was assessed by serum progesterone level determination.
A phase I sub-study to evaluate the pharmacokinetics of single subcutaneous administrations of rhLH was conducted on 24 healthy Chinese female subjects in China. The subjects were randomised into 3 groups. Each group received a single dose of 75 IU, 150 IU and 300 IU of r hLH. Blood samples were collected at predetermined intervals after the injection. Human LH serum levels were measured with the Serono MAIAclone and the in vitro bioassay MA-10. Safety was also assessed by the incidence and severity of adverse events and significant changes in laboratory values.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Peking Union Medical College Hospital
Published on BioPortfolio: 2014-08-27T03:15:18-0400
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