Clinical trial · Interventional
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata
NCT00152256CI-TRIAL-00001482completedPhase 3ClinicalTrials.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)
The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroid Uterus | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Menorrhagia | — | UNRESOLVED | — |
| Metrorrhagia | — | UNRESOLVED | — |
| 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
- Drug: Asoprisnil
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: Asoprisnil
- type
- PLACEBO_COMPARATOR
- label
- 3
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Cumulative percent of subjects achieving amenorrhea.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 53 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal women * History of regular menstrual cycles (21-42 days) * Diagnosis of uterine fibroid(s) * Abnormal vaginal bleeding associated with uterine fibroids * Otherwise in good health * Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small fibroids with a uterine volume of ≥ 200 cm3 Exclusion Criteria: * Less than 3 months postpartum and post-lactation * Previous myomectomy within 1 year * Any abnormal lab or procedure result the study-doctor considers important * Severe reaction(s) to or are currently using any hormone therapy * History of osteoporosis or other bone disease
References
Publications (0)
Data not yet available
No reference posted for this study.