NCT00156208

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2004

Typical duration for phase_3

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 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
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

Enrollment Period

2.7 years

First QC Date

September 7, 2005

Last Update Submit

May 27, 2008

Conditions

Fibroid UterusLeiomyomaMenorrhagiaMetrorrhagiaUterine Fibroids

Keywords

Symptomatic Uterine FibroidsExcessive Uterine BleedingUterine Hemorrhageasoprisnil

Outcome Measures

Primary Outcomes (1)

  • Long Term Safety

    Throughout 18 month treatment period

Secondary Outcomes (11)

  • Cumulative and incremental amenorrhea rates.

    Each month 1-18

  • Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.

    Final Visit

  • Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.

    Final Visit

  • Change from baseline in Uterine Fibroid Impact Questionnaire.

    Months 6, 12, 18

  • Change from baseline in the Work Limitation Questionnaire Index.

    Final Visit

  • +6 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Asoprisnil

2

EXPERIMENTAL
Drug: Asoprisnil

Interventions

AsoprisnilDRUG

10mg Tablet, oral Daily for 18 months

Also known as: J867
1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment
  • Otherwise good health
  • Premenopausal based on Estrogen and Follicle Stimulating Hormone levels
  • Agrees to double-barrier method of contraception
  • Adequate endometrial biopsy with no significant histological disorder

You may not qualify if:

  • Any abnormal lab or procedure result(s) the study-doctor considers important
  • History of a blood-clotting disorder
  • Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away
  • Significant gynecological disorder, such as endometrial polyp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LeiomyomaMenorrhagiaMetrorrhagiaUterine Hemorrhage

Interventions

asoprisnil

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Study Officials

  • Medical Director

    Abbott

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

April 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

May 29, 2008

Record last verified: 2008-05