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A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy

NCT ID: NCT00150644

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-05-31

Brief Summary

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The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and 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 effects of asoprisnil in uterine fibroid growth suppression. Full thickness biopsies obtained from surgical procedures will allow the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial angiogenesis. Various other exploratory immunohistological and biochemical specimens will be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the myometrium, and in uterine fibroids.

Conditions

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Uterine Fibroids Leiomyoma

Keywords

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Fibroid Uterus Leiomyoma Uterine Fibroids Hysterectomy 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

Asoprisnil 10mg Tablet, oral Daily for 12 weeks

2

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

Asoprisnil 25 mg Tablet, oral Daily for 12 weeks

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Tablet, oral Daily for 12 weeks

Interventions

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Asoprisnil

Asoprisnil 10mg Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Asoprisnil

Asoprisnil 25 mg Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Placebo

Placebo Tablet, oral Daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

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J867 J867

Eligibility Criteria

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Inclusion Criteria

* Premenopausal women, at least 18 years of age
* Diagnosis of uterine fibroid(s), confirmed by ultrasound
* History of menstrual cycles between 17 and 42 days
* Otherwise in good health
* Scheduled for a hysterectomy at the end of the treatment period
* Negative pregnancy test
* Agrees to double barrier method of contraception
* Pap test with no evidence of malignancy or pre-malignant changes
* Endometrial biopsy with no significant histological disorder

Exclusion Criteria

* 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 or are currently using any hormone therapy
* History of cancer or alcohol or drug abuse
* Diagnosis of Polycystic Ovary Syndrome
* History of prolactinoma
* Current use of Intrauterine Device
* Significant gynecological disorder
* Uterine size \> 32 weeks gestation
* Current diagnosis of endometriosis
* Uterine artery embolization within 6 months
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

References

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Williams AR, Critchley HO, Osei J, Ingamells S, Cameron IT, Han C, Chwalisz K. The effects of the selective progesterone receptor modulator asoprisnil on the morphology of uterine tissues after 3 months treatment in patients with symptomatic uterine leiomyomata. Hum Reprod. 2007 Jun;22(6):1696-704. doi: 10.1093/humrep/dem026. Epub 2007 Mar 5.

Reference Type RESULT
PMID: 17339234 (View on PubMed)

Other Identifiers

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C02-003

Identifier Type: -

Identifier Source: org_study_id