Clinical trial · Interventional
Study of Asoprisnil in the Treatment of Uterine Fibroids.
A Phase 3, Continuation Study to Evaluate the Long-Term Safety of Asoprisnil in Subjects With Uterine Leiomyomata
NCT00156156CI-TRIAL-00001480completedPhase 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 long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asoprisnil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Asoprisnil
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: Asoprisnil
Primary outcomes (1)
- measure
- Long-term Safety.
- timeFrame
- Throughout 2 year treatment period
Secondary outcomes (8)
- measure
- Change from baseline in the monthly bleeding score and the number of days with bleeding.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment * Otherwise in good health * Premenopausal based on Estrogen and FSH levels * Adequate endometrial biopsy with no significant histological disorder * Agrees to use double-barrier method of contraception Exclusion Criteria: * Any abnormal lab or procedure result(s) the study-doctor considers important * History of a blood-clotting disorder * History of osteoporosis requiring treatment * Any invasive procedure(s) (D\&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study * Hemoglobin \< 8.0 g/dL * Endometrial thickness ≥ 19 mm
References
Publications (0)
Data not yet available
No reference posted for this study.