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Clinical Trial Summary

The aim of the current study is the pharmacokinetic and pharmacodynamic characterization of a multiple dose administration of FSH-GEX™ in healthy pituitary-suppressed female volunteers, in comparison with two marketed comparator products or placebo.


Clinical Trial Description

Healthy pituitary-suppressed female subjects received multiple doses of FSH-GEX at one of 2 different dose levels (75 IU and 150 IU dosing once daily (QD), or 150 IU (dosing once every other day (QAD)) for maximal 7 Days. They were compared with subjects who received a urinary FSH or a recombinant FSH or placebo. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01477073
Study type Interventional
Source Glycotope GmbH
Contact
Status Completed
Phase Phase 1
Start date October 2011
Completion date May 2012

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