Follistatin 315
Activin-Binding Protein, FSH-Suppressing Protein, FST-315, FS-315
Completed
PHASE1
INTERVENTIONAL
NCT01477073
Multiple Dose FSH-GEX(TM) in Healthy Volunteers
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
FSH-GEX™
Type:
DRUG
Description:
Name:
recombinant FSH
Type:
DRUG
Description:
Name:
urinary FSH
Type:
DRUG
Description:
Name:
Placebo
Type:
DRUG
Description:
Primary Outcomes
Measure:
safety and tolerability of FSH-GEX™ following multiple dose administration by subcutaneous injection
TimeFrame:
43 days
Description:
frequency of dose related adverse events, measurement of vital signs, body measurements, transvaginal ultrasound, ECG and laboratory values in comparison to placebo and the two comparators with marketing authorization
Trial Information
NCT ID
NCT01477073
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Glycotope GmbH
Last Updated
December 15, 2025