NCT01354886

Single Dose FSH-GEX™ in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Glycotope GmbH · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The aim of the current study was the pharmacokinetic and pharmacodynamic characterization of a single dose administration of four doses of FSH-GEX™ in healthy pituitary-suppressed female volunteers, in comparison with two marketed comparator products.

Detailed description

Healthy pituitary-suppressed female subjects received FSH-GEX™ (25, 75, 150 and 300 IU) in three of four possible ascending doses or one dose of two comparators (Bravelle® and Gonal-f®) and placebo in random order. The study consisted of three separate treatment periods. During each treatment period the subject received one single dose via a subcutaneous injection in the lower abdominal wall.

Conditions

• Female Infertility

Interventions

Type	Name	Description
DRUG	FSH-GEX™	single dose
DRUG	Gonal-f	150 IU single dose
DRUG	Bravelle	150 IU single dose
DRUG	Placebo	single dose

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-05-17
• Last updated: 2021-05-11

Locations

1 site across 1 country: Netherlands