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A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.

NCT00776074 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2010-06-22

No results posted yet for this study

Summary

The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with uterine fibroids.

Conditions

  • Uterine Fibroids

Interventions

DRUG

Leuprorelin (GF)

Leuprorelin (GF) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.

DRUG

Leuprorelin (GC)

Leuprorelin (GC) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda Pharma Gmbh, Aachen (Germany)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-07-31
Completion
2007-07-31

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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 NCT00776074 on ClinicalTrials.gov