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

Phase 2 Completed 33 enrolled Abbott

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start: 2003-07
Primary completion: 2005-05
Completion: 2005-05

Publications

Results Williams 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Asoprisnil	Other / unclassified	10 mg	Oral
Subject	Asoprisnil	Other / unclassified	25 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications