Clinical trial · Interventional

Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

NCT00156195CI-TRIAL-00001492completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

Conditions

Conditions (3)

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
Menorrhagia	—	UNRESOLVED	—
Metrorrhagia	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Asoprisnil	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
1
interventionNames
1. Drug: Asoprisnil
type
EXPERIMENTAL
label
2
interventionNames
1. Drug: Asoprisnil

Primary outcomes (1)

measure
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
timeFrame
Month 12

Secondary outcomes (8)

measure
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
* Otherwise in good health
* Premenopausal based on Estrogen and FSH levels
* Agrees to use of double barrier method of contraception
* Adequate endometrial biopsy with no significant histological disorder

Exclusion Criteria:

* Any abnormal lab or procedure result(s) the study-doctor considers important
* Significant gynecological disorder such as confirmed endometrial polyp
* Hemoglobin \< 8.0 g/dL
* History of a blood-clotting disorder
* Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.

References

Publications (1)

DERIVEDDiamond MP, Stewart EA, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. A 12-month extension study to evaluate the safety and efficacy of asoprisnil in women with heavy menstrual bleeding and uterine fibroids. Hum Reprod Open. 2019 Nov 4;2019(4):hoz027. doi: 10.1093/hropen/hoz027. eCollection 2019. PMID 31777761