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A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

NCT ID: NCT00160459

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

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2001-07-31

Brief Summary

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This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.

Detailed Description

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No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study

Conditions

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Leiomyoma

Keywords

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Fibroid Uterus Leiomyoma Uterine Fibroids asoprisnil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

5 mg Tablet, oral Daily for 12 weeks

2

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

10 mg Tablet, oral Daily for 12 weeks

3

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

25 mg Tablet, oral Daily for 12 weeks

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet, oral Daily for 12 weeks

Interventions

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Asoprisnil

5 mg Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Asoprisnil

10 mg Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Asoprisnil

25 mg Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Placebo

Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women between 18 and 49 years of age
* Diagnosis of either 1 or more uterine fibroids
* History of regular menstrual cycles of 21 to 35 days in length.

Exclusion Criteria

* Any abnormal lab result the study-doctor considers significant
* History of severe reaction to or current use of hormone therapy
* History of osteoporosis or other bone disease
* History of uterine artery embolization, cryomyolysis, or electrical myolysis
* Subject currently breast feeding
* Hemoglobin \< 8 g/dL at baseline
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 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

References

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Chwalisz K, Larsen L, Mattia-Goldberg C, Edmonds A, Elger W, Winkel CA. A randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata. Fertil Steril. 2007 Jun;87(6):1399-412. doi: 10.1016/j.fertnstert.2006.11.094. Epub 2007 Feb 20.

Reference Type RESULT
PMID: 17307170 (View on PubMed)

Other Identifiers

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M99-144

Identifier Type: -

Identifier Source: org_study_id