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Multiple Dose FSH-GEX(TM) in Healthy Volunteers

NCT01477073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-05-07

No results posted yet for this study

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.

Conditions

  • Female Infertility

Interventions

DRUG

FSH-GEX™

DRUG

recombinant FSH

DRUG

urinary FSH

DRUG

Placebo

Sponsors & Collaborators

  • Glycotope Biotechnology GmbH

    collaborator INDUSTRY

  • Glycotope GmbH

    lead INDUSTRY

Principal Investigators

  • Glycotope GmbH Director · 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
2011-10-31
Primary Completion
2012-04-30
Completion
2012-05-31

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 NCT01477073 on ClinicalTrials.gov