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

Phase 3 Completed 523 enrolled Abbott

Non-randomizedParallel-groupSingle-blindTreatment

Summary

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

Timeline

Start: 2003-09
Primary completion: 2007-01
Completion: 2007-01

Publications

Diamond 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.

Drugs

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

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

Summary

Timeline

Publications

Drugs

Indications