Clinical trial · Interventional
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.
NCT00160459CI-TRIAL-00001485completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asoprisnil | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Asoprisnil
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: Asoprisnil
- type
- EXPERIMENTAL
- label
- 3
- interventionNames
- Drug: Asoprisnil
- type
- PLACEBO_COMPARATOR
- label
- 4
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 48 Years
Show eligibility criteria text
Inclusion Criteria: * Women between 18 and 49 years of age * Diagnosis of either 1 or more uterine fibroids * History of regular menstrual cycles of 21 to 35 days in length. Exclusion Criteria: * Any abnormal lab result the study-doctor considers significant * History of severe reaction to or current use of hormone therapy * History of osteoporosis or other bone disease * History of uterine artery embolization, cryomyolysis, or electrical myolysis * Subject currently breast feeding * Hemoglobin \< 8 g/dL at baseline
References
Publications (1)
- RESULTChwalisz K, Larsen L, Mattia-Goldberg C, Edmonds A, Elger W, Winkel CA. A randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata. Fertil Steril. 2007 Jun;87(6):1399-412. doi: 10.1016/j.fertnstert.2006.11.094. Epub 2007 Feb 20. PMID 17307170