NCT01477073

Multiple Dose FSH-GEX(TM) in Healthy Volunteers

A Phase I, Mono-center, Placebo and Comparator Controlled, Single-blind, Randomized, Parallel Group, Clinical Study to Determine Multiple Dose Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FSH-GEX(TM) Administered Subcutaneously in Healthy Pituitary-suppressed Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Glycotope GmbH · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Female Infertility

Interventions

Type	Name	Description
DRUG	FSH-GEX™
DRUG	recombinant FSH
DRUG	urinary FSH
DRUG	Placebo

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2011-11-22
• Last updated: 2021-05-07

Locations

1 site across 1 country: Netherlands