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Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

NCT00156195 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 523

Last updated 2008-05-29

No results posted yet for this study

Summary

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

Conditions

  • Leiomyoma
  • Menorrhagia
  • Metrorrhagia

Interventions

DRUG

Asoprisnil

10 mg Tablet, oral Daily for 12 months

DRUG

Asoprisnil

25 mg Tablet, oral Daily for 12 months

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Abbott

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2007-01-31
Completion
2007-01-31

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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 NCT00156195 on ClinicalTrials.gov