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Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids

NCT01452659 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2013-01-21

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with uterine fibroids.

Conditions

  • Uterine Fibroids

Interventions

DRUG

TAK-385

TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

TAK-385

TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

TAK-385

TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.

DRUG

Placebo

TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Senior Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT01452659 on ClinicalTrials.gov