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A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Women With Endometriosis From Study M01-398

NCT ID: NCT00160420

Last Updated: 2008-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2004-07-31

Brief Summary

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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.

Detailed Description

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Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. Although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. The objective of this study is to determine the long-term safety of asoprisnil 5 mg daily for 12 months in women with endometriosis, after an initial 12 weeks in study M01-398. The safety will be based on assessments of the endometrium, lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

Conditions

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Endometriosis

Keywords

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Pelvic pain Dysmenorrhea Dyspareunia Infertility asoprisnil

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

5mg Tablet, oral Daily for 12 months

Interventions

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Asoprisnil

5mg Tablet, oral Daily for 12 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Medical Director

Role: STUDY_CHAIR

Abbott

Other Identifiers

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M02-408

Identifier Type: -

Identifier Source: org_study_id