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

NCT ID: NCT00160381

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

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2005-01-31

Brief Summary

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The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

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 safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.

Conditions

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Leiomyoma Menorrhagia Metrorrhagia

Keywords

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Symptomatic Uterine Fibroids Excessive Uterine Bleeding Uterine Hemorrhage 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

10mg Tablet, oral Daily for 12 months

2

Group Type EXPERIMENTAL

Asoprisnil

Intervention Type DRUG

25 mg Tablet, oral Daily for 12 months

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet, oral Daily for 12 months

Interventions

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Asoprisnil

10mg Tablet, oral Daily for 12 months

Intervention Type DRUG

Asoprisnil

25 mg Tablet, oral Daily for 12 months

Intervention Type DRUG

Placebo

Tablet, oral Daily for 12 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Premenopausal women
* History of regular menstrual cycles (21-42 days)
* Diagnosis of uterine fibroid(s)
* Abnormal vaginal bleeding associated with uterine fibroids
* Otherwise in good health
* Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
* Negative pregnancy test
* Agrees to Double-barrier method of contraception
* Pap smear with no evidence of malignancy or pre-malignant changes
* Endometrial biopsy with no significant histological disorder

Exclusion Criteria

* Any abnormal lab or procedure result the study-doctor considers important
* Severe reaction(s) to or are currently using any hormone therapy
* History of osteoporosis or other bone disease
* Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
* History of Polycystic Ovary Syndrome or prolactinoma
* MRI shows significant gynecologic disorder
* Uterine size \> 25 weeks gestation
* Hemoglobin \< 8 g/dL at Day -1
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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Stewart EA, Diamond MP, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. Safety and efficacy of the selective progesterone receptor modulator asoprisnil for heavy menstrual bleeding with uterine fibroids: pooled analysis of two 12-month, placebo-controlled, randomized trials. Hum Reprod. 2019 Apr 1;34(4):623-634. doi: 10.1093/humrep/dez007.

Reference Type DERIVED
PMID: 30865281 (View on PubMed)

Larsen L, Coyne K, Chwalisz K. Validation of the menstrual pictogram in women with leiomyomata associated with heavy menstrual bleeding. Reprod Sci. 2013 Jun;20(6):680-7. doi: 10.1177/1933719112463252. Epub 2012 Nov 27.

Reference Type DERIVED
PMID: 23188490 (View on PubMed)

Other Identifiers

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M01-394

Identifier Type: -

Identifier Source: org_study_id