A Phase I, Monocenter, Randomized, Placebo and Comparator Controlled, Single Blind, Rising Dose, Clinical Study to Determine Single Dose Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Four Doses of FSH-GEX™ According to Adaptive Design (25, 75, 150 and 300 IU) Administered Subcutaneously in Healthy Pituitary-suppressed Female Volunteers

Trial Profile

A Phase I, Monocenter, Randomized, Placebo and Comparator Controlled, Single Blind, Rising Dose, Clinical Study to Determine Single Dose Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Four Doses of FSH-GEX™ According to Adaptive Design (25, 75, 150 and 300 IU) Administered Subcutaneously in Healthy Pituitary-suppressed Female Volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 25 Nov 2011

At a glance

  • Drugs Follicle-stimulating hormone glyco-optimised (Primary) ; Infertility therapies
  • Indications Female infertility
  • Focus Adverse reactions; Pharmacokinetics
  • Most Recent Events

    • 20 Sep 2011 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
    • 21 May 2011 New trial record
    • 18 May 2011 Glycotope enrolls first patients in this trial, according to a company media release.
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