A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00156182

Enrollment

Registered

2005-09-12

Start date

2001-04-30

Completion date

2001-12-31

Last updated

2009-03-04

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 long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

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 long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.

Interventions

DRUGAsoprisnil

10mg Tablet, oral Daily for 6 months

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 48 Years

Healthy volunteers

Inclusion criteria

* Completed dosing and Day 84 procedures at sites in study M99-144 * No interruption of dosing * Otherwise continued good health

Exclusion criteria

* Any abnormal lab result the study-doctor considers significant * History of severe reaction to or current use of hormone therapy * History of alcohol or drug abuse

Design outcomes

Primary

Measure	Time frame
Percentage of subjects that achieved amenorrhea.	Treatment months 1-6
Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144	Treatment months 3 and 6 and Post-treatment months 3 and 6

Secondary

Measure	Time frame
Change from baseline in uterine size in gestational weeks.	Months 3 and 6
Duration of amenorrhea.	Start of previous study to first post-treatment menses.
Improvement in hematologic parameters.	Treatment months 2,4,and 6
Mean change from baseline for endocrine determinations.	Months 2,4 and 6
Response to global efficacy question regarding improvement of fibroid symptoms.	Month 6
Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale	Treatment Months 1-6

Outcome results

None listed

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