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Single Dose FSH-GEX™ in Healthy Volunteers

NCT01354886 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-05-11

No results posted yet for this study

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.

Conditions

  • Female Infertility

Interventions

DRUG

FSH-GEX™

single dose

DRUG

Gonal-f

150 IU single dose

DRUG

Bravelle

150 IU single dose

DRUG

Placebo

single dose

Sponsors & Collaborators

  • Glycotope Biotechnology GmbH

    collaborator INDUSTRY

  • Glycotope GmbH

    lead INDUSTRY

Principal Investigators

  • Glycotope GmbH · Glycotope GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01354886 on ClinicalTrials.gov