Clinical trial · Interventional

A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy

A Phase 2, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.

NCT00150644CI-TRIAL-00001487completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.

Conditions

Conditions (2)

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
Uterine Fibroids	Uterine Corpus Leiomyoma	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Asoprisnil	Drug	—	UNRESOLVED
Placebo	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
1
interventionNames
1. Drug: Asoprisnil
type
EXPERIMENTAL
label
2
interventionNames
1. Drug: Asoprisnil
type
PLACEBO_COMPARATOR
label
3
interventionNames
1. Drug: Placebo

Primary outcomes (1)

measure
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Premenopausal women, at least 18 years of age
* Diagnosis of uterine fibroid(s), confirmed by ultrasound
* History of menstrual cycles between 17 and 42 days
* Otherwise in good health
* Scheduled for a hysterectomy at the end of the treatment period
* Negative pregnancy test
* Agrees to double barrier method of contraception
* Pap test with no evidence of malignancy or pre-malignant changes
* Endometrial biopsy with no significant histological disorder

Exclusion Criteria:

* Less than 3 months after having a baby or breast-feeding
* Any abnormal lab or procedure result the study-doctor considers important
* Severe reaction(s) to or are currently using any hormone therapy
* History of cancer or alcohol or drug abuse
* Diagnosis of Polycystic Ovary Syndrome
* History of prolactinoma
* Current use of Intrauterine Device
* Significant gynecological disorder
* Uterine size \> 32 weeks gestation
* Current diagnosis of endometriosis
* Uterine artery embolization within 6 months

References

Publications (1)

RESULTWilliams AR, Critchley HO, Osei J, Ingamells S, Cameron IT, Han C, Chwalisz K. The effects of the selective progesterone receptor modulator asoprisnil on the morphology of uterine tissues after 3 months treatment in patients with symptomatic uterine leiomyomata. Hum Reprod. 2007 Jun;22(6):1696-704. doi: 10.1093/humrep/dem026. Epub 2007 Mar 5. PMID 17339234