NCT00160433

Brief Summary

The objective of this study is to determine the safety and efficacy of 3 asoprisnil doses (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2002

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
2.3 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

10 months

First QC Date

September 8, 2005

Last Update Submit

May 27, 2008

Conditions

Endometriosis

Keywords

Pelvic painDysmenorrheaDyspareuniaInfertilityasoprisnil

Outcome Measures

Primary Outcomes (2)

  • Mean change from baseline in pelvic pain as assessed by daily diary

    Final month

  • Mean change from baseline in dysmenorrhea as assessed by daily diary

    Final month

Secondary Outcomes (13)

  • Change from baseline in pelvic pain and dysmenorrhea scores from the daily diary.

    Months 1,2,3 and Months 1-3

  • Change from baseline in dyspareunia and the combined pelvic pain/dysmenorrhea scores from the daily diary.

    Months 1,2,3 and Months 1-3 and the Final Month

  • Change from baseline in the percentage of days with mild or greater combined pelvic pain/dysmenorrhea and moderate or greater combined pelvic pain/dysmenorrhea based on the daily diary.

    Months 1,2,3 and Months 1-3 and Final Month

  • Change from baseline for pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration scores assessed by the modified Biberoglu and Behrman pain scale.

    Months 1,2,3 and Final Visit

  • Change from baseline in pelvic pain and dysmenorrhea assessed via the Visual Analog Scale.

    Months 1,2,3 and Final Visit

  • +8 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL
Drug: Asoprisnil

2

EXPERIMENTAL
Drug: Asoprisnil

3

EXPERIMENTAL
Drug: Asoprisnil

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AsoprisnilDRUG

0.5 mg Tablet, oral Daily for 12 weeks

1
PlaceboDRUG

Tablet, oral Daily for 12 weeks

4

Eligibility Criteria

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

You may qualify if:

  • Premenopausal women (18-40 years)
  • Surgically confirmed endometriosis within 3 years
  • History of menstrual cycles between 21 and 35 days
  • Moderate or severe pelvic pain OR moderate or severe dysmenorrhea OR moderate or severe pelvic tenderness accompanied by at least mild non-menstrual pelvic pain
  • Negative pregnancy test
  • Agrees to use double barrier method of contraception
  • Pap smear with no evidence of malignancy or pre-malignant changes
  • Ultrasound with no significant gynecological disorder.
  • Otherwise in good health

You may not qualify if:

  • Less than 3 months after having a baby or breast-feeding
  • Any abnormal lab or procedure result the study-doctor considers important
  • Severe reaction(s) to hormone therapy
  • Anticipated need for excluded hormonal therapy or unapproved narcotics
  • Current use of an IUD
  • History or prolactinoma

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
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2002

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

May 29, 2008

Record last verified: 2008-05