NCT00156156

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2004

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

November 1, 2004

Completed
10 months 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
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

May 28, 2008

Status Verified

May 1, 2008

Enrollment Period

2.3 years

First QC Date

September 7, 2005

Last Update Submit

May 27, 2008

Conditions

Fibroid UterusLeiomyomaMenorrhagiaMetrorrhagiaUterine Fibroids

Keywords

Symptomatic Uterine FibroidsExcessive Uterine BleedingUterine Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Long-term Safety.

    Throughout 2 year treatment period

Secondary Outcomes (8)

  • Change from baseline in the monthly bleeding score and the number of days with bleeding.

    Each Month

  • Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations.

    Months 3, 6, 9,12,15,18, 24

  • Percent change from baseline in volume of the largest fibroid.

    Months 12, 24

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

    Months 6, 12, 18, 24

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

    Months 6, 12, 18, 24

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Asoprisnil

2

EXPERIMENTAL
Drug: Asoprisnil

Interventions

AsoprisnilDRUG

Asoprisnil 10 mg Tablet, oral Daily for up to 2 years

Also known as: J867
1

Eligibility Criteria

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

You may qualify if:

  • Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment
  • Otherwise in good health
  • Premenopausal based on Estrogen and FSH levels
  • Adequate endometrial biopsy with no significant histological disorder
  • Agrees to use double-barrier method of contraception

You may not qualify if:

  • Any abnormal lab or procedure result(s) the study-doctor considers important
  • History of a blood-clotting disorder
  • History of osteoporosis requiring treatment
  • Any invasive procedure(s) (D\&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study
  • Hemoglobin \< 8.0 g/dL
  • Endometrial thickness ≥ 19 mm

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

November 1, 2004

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

May 28, 2008

Record last verified: 2008-05