Clinical trial · Interventional

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

NCT00156182CI-TRIAL-00002109completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leiomyoma	Leiomyoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Asoprisnil	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
1
interventionNames
1. Drug: Asoprisnil

Primary outcomes (2)

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

Secondary outcomes (6)

measure
Improvement in hematologic parameters.
timeFrame
Treatment months 2,4,and 6

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.