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Safety of Treatment of Uterine Fibroids With Asoprisnil

NCT ID: NCT00156208

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

PHASE3

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Conditions

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Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids

Keywords

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Symptomatic Uterine Fibroids Excessive Uterine Bleeding Uterine Hemorrhage asoprisnil

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

10mg Tablet, oral Daily for 18 months

2

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

25 mg Tablet, oral Daily for 18 months

Interventions

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Asoprisnil

10mg Tablet, oral Daily for 18 months

Intervention Type DRUG

Asoprisnil

25 mg Tablet, oral Daily for 18 months

Intervention Type DRUG

Other Intervention Names

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J867 J867

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 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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C03-062

Identifier Type: -

Identifier Source: org_study_id