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

Primary Purpose

Leiomyoma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Asoprisnil

Placebo

About this trial

This is an interventional treatment trial for Leiomyoma focused on measuring Fibroid Uterus, Leiomyoma, Uterine Fibroids, asoprisnil

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Percent change from baseline in uterine volume and volume of the largest fibroid.

Duration of amenorrhea

Secondary Outcome Measures

Change from baseline in uterine size in gestational weeks.

Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume.

Percentage of days with bleeding.

Changes in hematologic and iron parameters.

Uterine fibroid symptom improvement.

Response to Global Efficacy Question regarding improvement in fibroid symptoms.

Full Information

NCT ID

NCT00160459

First Posted

September 8, 2005

Last Updated

May 27, 2008

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00160459

Brief Title

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

Official Title

A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

May 2000 (undefined)

Primary Completion Date

July 2001 (Actual)

Study Completion Date

July 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leiomyoma

Keywords

Fibroid Uterus, Leiomyoma, Uterine Fibroids, asoprisnil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

129 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Asoprisnil

Intervention Description

5 mg Tablet, oral Daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Asoprisnil

Intervention Description

10 mg Tablet, oral Daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Asoprisnil

Intervention Description

25 mg Tablet, oral Daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Tablet, oral Daily for 12 weeks

Primary Outcome Measure Information:

Title

Percent change from baseline in uterine volume and volume of the largest fibroid.

Time Frame

Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.

Title

Duration of amenorrhea

Time Frame

Day 1 to 1st post treatment menses

Secondary Outcome Measure Information:

Title

Change from baseline in uterine size in gestational weeks.

Time Frame

Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6

Title

Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume.

Time Frame

Week 12 and final visit

Title

Percentage of days with bleeding.

Time Frame

Day 1 through end of 1st post-treatment menses

Title

Changes in hematologic and iron parameters.

Time Frame

Baseline to each visit

Title

Uterine fibroid symptom improvement.

Time Frame

Baseline to each visit

Title

Response to Global Efficacy Question regarding improvement in fibroid symptoms.

Time Frame

Week 12 and Final Visit

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

48 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Abbott

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

17307170

Citation

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.

Results Reference

result

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

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