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Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

NCT00117949 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2011-05-23

Study results available
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Summary

Population pharmacokinetic and pharmacodynamic data from Study FE200486 CS06 and FE200486 CS02 provided further knowledge of the optimal dose regimens for FE200486 (degarelix). Both studies were to guide dose selection for phase III. In addition, safety and tolerance data were generated.

Conditions

Interventions

DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.

DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.

DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.

DRUG

Degarelix

One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2004-01-31
Completion
2004-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00117949 on ClinicalTrials.gov