NCT00156182

Brief Summary

This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2001

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

March 4, 2009

Status Verified

May 1, 2008

Enrollment Period

8 months

First QC Date

September 7, 2005

Last Update Submit

March 3, 2009

Conditions

Leiomyoma

Keywords

Fibroid UterusLeiomyomaUterine Fibroidsasoprisnil

Outcome Measures

Primary Outcomes (2)

  • Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144

    Treatment months 3 and 6 and Post-treatment months 3 and 6

  • Percentage of subjects that achieved amenorrhea.

    Treatment months 1-6

Secondary Outcomes (6)

  • Improvement in hematologic parameters.

    Treatment months 2,4,and 6

  • Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale

    Treatment Months 1-6

  • Change from baseline in uterine size in gestational weeks.

    Months 3 and 6

  • Duration of amenorrhea.

    Start of previous study to first post-treatment menses.

  • Response to global efficacy question regarding improvement of fibroid symptoms.

    Month 6

  • +1 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Drug: Asoprisnil

Interventions

AsoprisnilDRUG

10mg Tablet, oral Daily for 6 months

1

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Completed dosing and Day 84 procedures at sites in study M99-144
  • No interruption of dosing
  • Otherwise continued good health

You may not qualify if:

  • Any abnormal lab result the study-doctor considers significant
  • History of severe reaction to or current use of hormone therapy
  • History of alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leiomyoma

Interventions

asoprisnil

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Medical Director

    Abbott

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

April 1, 2001

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

March 4, 2009

Record last verified: 2008-05