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
Phase of Trial: Phase I
Latest Information Update: 01 Aug 2017
At a glance
- Drugs Follicle-stimulating hormone glyco-optimised (Primary)
- Indications Female infertility
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Glycotope
- 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.