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Safety of Treatment of Uterine Fibroids With Asoprisnil

NCT00156208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 166

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 symptomatic uterine fibroids who completed the 6 month Study C02-037.

Conditions

  • Fibroid Uterus
  • Leiomyoma
  • Menorrhagia
  • Metrorrhagia
  • Uterine Fibroids

Interventions

DRUG

Asoprisnil

10mg Tablet, oral Daily for 18 months

DRUG

Asoprisnil

25 mg Tablet, oral Daily for 18 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
2004-04-30
Primary Completion
2006-12-31
Completion
2006-12-31

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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 NCT00156208 on ClinicalTrials.gov