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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160459

Enrollment

129

Registered

2005-09-12

Start date

2000-05-31

Completion date

2001-07-31

Last updated

2008-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leiomyoma

Keywords

Fibroid Uterus, Leiomyoma, Uterine Fibroids, asoprisnil

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

Interventions

DRUGAsoprisnil

5 mg Tablet, oral Daily for 12 weeks

DRUGPlacebo

Tablet, oral Daily for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 48 Years

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

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in uterine volume and volume of the largest fibroid.	Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.
Duration of amenorrhea	Day 1 to 1st post treatment menses

Secondary

Measure	Time frame
Percentage of days with bleeding.	Day 1 through end of 1st post-treatment menses
Changes in hematologic and iron parameters.	Baseline to each visit
Change from baseline in uterine size in gestational weeks.	Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6
Response to Global Efficacy Question regarding improvement in fibroid symptoms.	Week 12 and Final Visit
Uterine fibroid symptom improvement.	Baseline to each visit
Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume.	Week 12 and final visit

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026