NCT00160420

Brief Summary

The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12 months in women with endometriosis from study M01-398.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2002

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

December 1, 2002

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

Enrollment Period

1.6 years

First QC Date

September 8, 2005

Last Update Submit

May 27, 2008

Conditions

Endometriosis

Keywords

Pelvic painDysmenorrheaDyspareuniaInfertilityasoprisnil

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale.

    Months 1,3,6,9,12 and final visit

  • Change from baseline in pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration assessed by modified Biberoglu and Behrman grading scale.

    Months 3,6,9,12 and final visit

Secondary Outcomes (1)

  • Percentage of subjects with amenorrhea.

    Throught treatment period.

Study Arms (1)

1

EXPERIMENTAL
Drug: Asoprisnil

Interventions

AsoprisnilDRUG

5mg Tablet, oral Daily for 12 months

1

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Completed 3 months of dosing and Month 3 procedures in study M01-398
  • Otherwise in good health
  • Month 3 (M01-398) ultrasound reveals no significant gynecologic disorder

You may not qualify if:

  • Any abnormal lab or procedure result the study-doctor considers important
  • Anticipated need for excluded hormonal therapy or unapproved narcotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EndometriosisPelvic PainDysmenorrheaDyspareuniaInfertility

Interventions

asoprisnil

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMenstruation DisturbancesPathologic ProcessesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

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 8, 2005

First Posted

September 12, 2005

Study Start

December 1, 2002

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

May 29, 2008

Record last verified: 2008-05