drugset / Trial / NCT00160381
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
RandomizedParallel-groupTriple-blindTreatment
Summary
The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.
Timeline
- Start
- 2002-09
- Primary completion
- 2005-01
- Completion
- 2005-01
Publications
- Stewart EA, Diamond MP, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. Safety and efficacy of the selective progesterone receptor modulator asoprisnil for heavy menstrual bleeding with uterine fibroids: pooled analysis of two 12-month, placebo-controlled, randomized trials. Hum Reprod. 2019 Apr 1;34(4):623-634. doi: 10.1093/humrep/dez007.
- Larsen L, Coyne K, Chwalisz K. Validation of the menstrual pictogram in women with leiomyomata associated with heavy menstrual bleeding. Reprod Sci. 2013 Jun;20(6):680-7. doi: 10.1177/1933719112463252. Epub 2012 Nov 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asoprisnil | Other / unclassified | 10 mg | Oral |
| Subject | Asoprisnil | Other / unclassified | 25 mg | Oral |